82_FR_36123 82 FR 35976 - Request for Letters of Interest for NCI-MATCH Laboratories

82 FR 35976 - Request for Letters of Interest for NCI-MATCH Laboratories

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 147 (August 2, 2017)

Page Range35976-35978
FR Document2017-16203

The National Cancer Institute (NCI) in collaboration with the NCI Molecular Analysis for Therapy Choice (MATCH) trial leadership (NCT 02465060) invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next Generation Sequencing (NGS) assays to participate in the NCI MATCH trial. The NCI MATCH trial has implemented a new process for identifying patients for arms with rare variant eligibility criteria. Laboratories will contact any of the approximately 1100 sites that have activated NCI MATCH if a specimen sent from one of these sites has a rare variant that would potentially make the patient eligible for one of the treatment arms open in this initiative.

Federal Register, Volume 82 Issue 147 (Wednesday, August 2, 2017)
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35976-35978]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16203]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Letters of Interest for NCI-MATCH Laboratories

SUMMARY: The National Cancer Institute (NCI) in collaboration with the 
NCI Molecular Analysis for Therapy Choice (MATCH) trial leadership (NCT 
02465060) invites applications for Clinical Laboratory Improvements 
Program (CLIA) certified/accredited laboratories that test tumor 
specimens from patients utilizing Next Generation Sequencing (NGS) 
assays to participate in the NCI MATCH trial. The NCI MATCH trial has 
implemented a new process for identifying patients for arms with rare 
variant eligibility criteria. Laboratories will contact any of the 
approximately 1100 sites that have activated NCI MATCH if a specimen 
sent from one of these sites has a rare variant that would potentially 
make the patient eligible for one of the treatment arms open in this 
initiative.

DATES: LOIs should be submitted to the National Cancer Institute (NCI), 
National Institutes of Health (NIH) on or before 5:00 p.m. EST on 
January 31, 2018.

ADDRESSES: Submit LOIs by email to NCIMATCHLabApps@nih.gov. 9609 
Medical Center Drive, 3 West, Room 526, MSC 9728, Rockville, MD 20892.

FOR FURTHER INFORMATION CONTACT: Questions about this request for LOIs 
should be directed to NCIMATCHLabApps@nih.gov. James V. Tricoli 
tricolij@mail.nih.gov can also provide further information.

SUPPLEMENTARY INFORMATION: NCI-MATCH aims to establish whether patients 
with tumor mutations, amplifications or translocations in one of the 
genetic pathways of interest are likely to derive clinical benefit 
(primary objective: Objective response; secondary objective: 
Progression-free survival of at least 6 months) if treated with agents 
targeting that specific pathway in a single-arm design (see current 
arms below).
    Patients with histologically documented solid tumors, lymphomas and 
multiple myeloma whose disease has progressed following at least one 
line of standard systemic therapy or for whom no standard therapy 
exists are eligible if they meet the eligibility criteria for the 
trial. Further information about the NCI-MATCH trial may be found at 
http://ecog-acrin.org/trials/nci-match-eay131.
    The selected collaborating laboratories may only act (i.e., refer 
patients) on any of the rare variant arms for which their assay reports 
actionable mutations of interest (aMOIs). The assay must also report 
all exclusionary variants for the arm unless these occur at a frequency 
of >1% in cancer patients.
    CLIA accredited/certified laboratories located in the United States 
may be

[[Page 35977]]

considered for addition to the laboratory network.

Letter of Interest (LOI) and Collaboration Agreement

    Candidate laboratories should submit a letter of interest to 
NCIMATCHLabApps@nih.gov stating:

 Statement of interest in the proposed activity
 Laboratory name
 Lead contact name, address, email address, and telephone 
number
 CLIA certification number
 Assay name
 Brief description of assay
    [cir] Sensitivity and specificity for SNVs, indels, CNV, fusions
    [cir] Method of analysis
    [cir] Platform and variant calling
 Number of assays per month
 Number of patients whose assay results would make them 
potentially eligible for the rare variant arms (below) in the last 6 
months
 Willingness to contact sites regarding results with a rare 
variant potentially eligible for NCI MATCH
 Willingness to sign a collaboration agreement with NCI and to 
share data and publication rights
 Which arms the laboratory is prepared to address.

    The arms that are included in the rare variant protocol amendment 
are:

----------------------------------------------------------------------------------------------------------------
             Rare variant candidate                                 MATCH subprotocol (agent)
----------------------------------------------------------------------------------------------------------------
AKT1 mut.......................................  EAY131-Y (AZD5363).
NF2 loss.......................................  EAY131-U (Defactinib).
MET amplification..............................  EAY131-C1 (Crizotinib).
BRAF V600......................................  EAY131-H (Dabrafenib + Trametinib).
SMO/PTCH1......................................  EAY131-T (Vismodegib).
BRAF non V600..................................  EAY131-R (Trametinib).
EGFR T790M.....................................  EAY131-E (AZD9291).
ALK translocation..............................  EAY131-F (Crizotinib).
cKIT mutation..................................  EAY131-V (Sunitinib).
EGFR mutation..................................  EAY131-A (Afatinib).
ROS1 translocation.............................  EAY131-G (Crizotinib).
GNAQ/GNA11.....................................  EAY131-S2 (Trametinib).
MET exon 14 skipping...........................  EAY131-C2 (Crizotinib).
NTRK fusions...................................  EAY131 Z1E (Loxo101).
MTOR mutations.................................  EAY131-L (MLN0128).
TSC1 or TSC2 mutations.........................  EAY131-M (MLN0128).
CCND 1,2,3 amplifications......................  EAY131-Z1B (Palbociclib).
CDK4 or CDK6 amplification.....................  EAY131-Z1C (Palbociclib).
DDR2 mutation..................................  EAY131-X (Dasatinib).
----------------------------------------------------------------------------------------------------------------

    Following an acceptable eligibility review to the NCI MATCH 
screening committee, the laboratory would execute a confidentiality 
agreement with the NCI and will be provided with a detailed list of 
eligibility and exclusion variants for arms in which the lab has 
interest. The lab would then be required to submit an application 
within 3 months for review by the NCI-MATCH steering committee. 
Candidate laboratories will be required to meet the following general 
requirements:
     Testing must be performed in a CLIA-certified or -
accredited laboratory located in the United States.
     Assays must be on tumor tissue only (including lymphoma 
and myeloma). Assays using circulating nucleic acids will not be 
accepted at this time.
     Laboratory NGS panels must be analytically and clinically 
validated, with performance characteristics as follows:

[cir] Specificity at least 99% for single nucleotide variants, indels
[cir] Sensitivity at least 95% for single nucleotide variants, indels
[cir] Sensitivity of 90% for copy number variants (state fold of copy 
number variants that can be detected with 90% sensitivity)
[cir] 99% reproducibility between sequencers (if more than one 
sequencer is used) and between operators
[cir] Lower limit of detection for SNV, indels, CNV must be stated.

    Laboratories must supply the following information in their 
application:

[cir] Lower limit of % tumor accepted, and whether (and which) 
enrichment procedures are employed
[cir] Whether the lab archives images of slides from the tumor
[cir] Whether the lab also runs germline as well as tumor with the 
assay (a simultaneous germline sequencing is not required by NCI MATCH)
[cir] A detailed description of assay procedures, including starting 
material, extraction of nucleic acids, quality assurance, quality 
metrics, data analysis and filters must be supplied.

     Laboratory NGS test panels must interrogate actionable 
mutations of interest (aMOIs) required for enrollment into the Rare 
Variant Arms (see table above). Applicant laboratories must state the 
MATCH arms in which they would like to participate.
     Academic laboratories must be located at a center that 
participates in NCI MATCH.
     As it is important that the dataset used for analysis in 
NCI MATCH be as robust as possible, the laboratory NGS test will 
require qualification, during which the performance of the laboratory 
will be compared with the NCI-MATCH central laboratory test to ensure 
good agreement with that assay. Concordance between the results from 
each lab and results of the NCI MATCH NGS assay run on an archived 
specimen will be tracked; if concordance falls below 90% for SNVs and 
indels, or 80% for CNVs, the laboratory must be willing to address 
these issues with the NCI MATCH team. If they cannot be addressed to 
the satisfaction of the NCI MATCH team, the laboratory may be 
eliminated from participation in NCI MATCH.
     Laboratories shall NOT advertise that they are screening 
laboratories for MATCH eligibility. Any press release or public 
disclosure requires clearance by NCI and NCI MATCH.
     Laboratories must agree to use the existing workflow 
established by the NCI MATCH trial to identify patients for the Rare 
Variant Arms. This includes use of the MATCH Rare Variant

[[Page 35978]]

template to identify aMOIs for submission to MATCHbox.

[cir] Laboratory results of NGS assays done for clinical care will be 
the subject of this initiative. There is no funding for ``screening'' a 
patient for MATCH.
[cir] Laboratories must notify NCI MATCH sites that the laboratory 
results would potentially allow the patient to be eligible for NCI 
MATCH.
[cir] Laboratories must track how many assays per week detect rare 
variants that could make a patient eligible for NCI MATCH.
    [cir] If the clinician presents the MATCH study and the patient is 
eligible and desires to enter the study, the laboratory must agree to 
fill out a spreadsheet that can be used to put the results into the 
informatics system that assigns treatment in NCI MATCH (MATCHbox).
    [cir] Laboratories must have a way to answer questions from NCI 
MATCH sites about their assay and must have a contact person for 
optimal communication with the NCI MATCH team.
     Prior to participation, laboratories must enter into a 
collaboration agreement with NCI. A sample agreement is available upon 
request. As part of such a collaboration agreement, laboratories must 
agree to provide the licensing rights described in the CTEP IP Option 
to the Pharmaceutical Collaborators who provided agents for the NCI 
MATCH trial (https://ctep.cancer.gov/branches/rab/intellectual_property_optionto_collaborators.htm), as well as agree to 
the data sharing and publication rights consistent with those 
agreements.
     No reimbursement for these activities (testing or 
notification of sites of NCI MATCH eligibility) exists.
    Qualified laboratories serving underserved populations are 
encouraged to participate.
    How to apply:
    1. Submit letter of interest (LOI) as described above under 
``Letter of Interest and Collaboration Agreement'' to 
NCIMATCHLabApps@nih.gov.
    2. LOIs will be accepted until January 31, 2018 at 5:00 p.m. 
Eastern Time. LOIs will be reviewed on a monthly basis, with those 
arriving by the 15th day of the month being reviewed and answered by 
the 15th day of the following month.
    3. Notification of acceptance, non-acceptance or questions from 
Steering Committee will be sent to the designated contact person as 
soon as the LOI has been reviewed. This notification will include 
further instructions if a full application is invited.
    4. Applications that have not been submitted within 3 months of 
notification of acceptance will be de-activated, and a new LOI must 
then be submitted if the laboratory wishes to participate in NCI MATCH.
    5. DO NOT send a full application until you are invited to do so.
    Review criteria for LOI:
     Laboratory is a CLIA certified or accredited laboratory 
within the United States.
     Academic laboratories must have NCI MATCH open at their 
site.
     Laboratory has adequate sensitivity, specificity.
     Laboratory tests tumor tissue for rare variants as 
described in NCI MATCH.
     Laboratory agrees to provide needed information for 
evaluation of the analytical validity of the test.
     Laboratory is likely to refer at least 100 patients to NCI 
MATCH based on detection of rare variants in the past.
     Laboratory agrees to contact sites regarding NCI MATCH 
eligibility.
     Laboratory agrees to a collaboration with NCI as detailed 
above.
    Review criteria for full application:
     Laboratory NGS assay interrogates inclusionary and all 
exclusionary variants for arms in which the laboratory will 
participate.
     Laboratory supplies evidence that the assay meets 
analytical requirements as detailed above.
     Laboratories are capable of contacting clinical sites, 
tracking activity, and of referring at least 100 patients to the study 
based on detection of rare variants in the past.
     Laboratories agree to execute a collaboration agreement 
with NCI, as well as to data sharing and sharing publication rights.
     Laboratories agree to abide by the procedures in place for 
the MATCH study and to collaborate fully with the MATCH team.
    For more information, contact NCIMATCHLabApps@nih.gov.

    Dated: July 20, 2017.
James V. Tricoli,
Chief, Diagnostic Biomarkers and Technology Development Branch, Cancer 
Diagnosis Program, Division of Cancer Treatment and Diagnosis, National 
Cancer Institute.
[FR Doc. 2017-16203 Filed 8-1-17; 8:45 am]
 BILLING CODE 4140-01-P



                                                35976                      Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices

                                                applications, the disclosure of which                   Room 7323, MSC 5452, Bethesda, MD 20892,              Molecular Analysis for Therapy Choice
                                                would constitute a clearly unwarranted                  (301) 594–8843, stanfibr@niddk.nih.gov.               (MATCH) trial leadership (NCT
                                                invasion of personal privacy.                             Name of Committee: National Diabetes and            02465060) invites applications for
                                                                                                        Digestive and Kidney Diseases Advisory                Clinical Laboratory Improvements
                                                  Name of Committee: National Diabetes and              Council; Digestive Diseases and Nutrition.
                                                Digestive and Kidney Diseases Advisory                                                                        Program (CLIA) certified/accredited
                                                                                                          Date: September 6, 2017.
                                                Council.                                                                                                      laboratories that test tumor specimens
                                                                                                          Open: 1:00 p.m. to 2:00 p.m.
                                                  Date: September 6, 2017.                                Agenda: To review the Division’s scientific         from patients utilizing Next Generation
                                                  Open: 8:30 a.m. to 12:00 p.m.                         and planning activities.                              Sequencing (NGS) assays to participate
                                                  Agenda: To present the Director’s Report                Place: National Institutes of Health,               in the NCI MATCH trial. The NCI
                                                and other scientific presentations.                     Natcher Building Forty-five, Natcher                  MATCH trial has implemented a new
                                                  Place: National Institutes of Health,                 Conference Center, Room F1, 45 Center                 process for identifying patients for arms
                                                Natcher Building Forty-five, Conference                 Drive, Bethesda, MD 20892.
                                                Rooms E1/E2, 45 Center Drive, Bethesda, MD
                                                                                                                                                              with rare variant eligibility criteria.
                                                                                                          Closed: 2:15 p.m. to 3:30 p.m.                      Laboratories will contact any of the
                                                20892.                                                    Agenda: To review and evaluate grant
                                                  Closed: 3:45 p.m. to 4:30 p.m.                                                                              approximately 1100 sites that have
                                                                                                        applications.
                                                  Agenda: To review and evaluate grant                                                                        activated NCI MATCH if a specimen
                                                                                                          Place: National Institutes of Health,
                                                applications.                                           Natcher Building Forty-five, Natcher                  sent from one of these sites has a rare
                                                  Place: National Institutes of Health,                 Conference Center, Room F1, 45 Center                 variant that would potentially make the
                                                Natcher Building Forty-five, Conference                 Drive, Bethesda, MD 20892.                            patient eligible for one of the treatment
                                                Rooms E1/E2, 45 Center Drive, Bethesda, MD                 Contact Person: Brent B. Stanfield, Ph.D.,         arms open in this initiative.
                                                20892.                                                  Director, Division of Extramural Activities,
                                                  Contact Person: Brent B. Stanfield, Ph.D.,                                                                  DATES: LOIs should be submitted to the
                                                                                                        National Institutes of Diabetes and Digestive         National Cancer Institute (NCI),
                                                Director, Division of Extramural Activities,            and Kidney Diseases, 6707 Democracy Blvd.
                                                National Institutes of Diabetes and Digestive                                                                 National Institutes of Health (NIH) on or
                                                                                                        Room 7323, MSC 5452, Bethesda, MD 20892,
                                                and Kidney Diseases, 6707 Democracy Blvd.               (301) 594–8843, stanfibr@niddk.nih.gov.
                                                                                                                                                              before 5:00 p.m. EST on January 31,
                                                Room 7323, MSC 5452, Bethesda, MD 20892,                                                                      2018.
                                                (301) 594–8843, stanfibr@niddk.nih.gov.                    Any interested person may file written
                                                                                                        comments with the committee by forwarding             ADDRESSES: Submit LOIs by email to
                                                  Name of Committee: National Diabetes and              the statement to the Contact Person listed on         NCIMATCHLabApps@nih.gov. 9609
                                                Digestive and Kidney Diseases Advisory                  this notice. The statement should include the
                                                Council; Diabetes, Endocrinology and
                                                                                                                                                              Medical Center Drive, 3 West, Room
                                                                                                        name, address, telephone number and when              526, MSC 9728, Rockville, MD 20892.
                                                Metabolic Diseases.                                     applicable, the business or professional
                                                  Date: September 6, 2017.                                                                                    FOR FURTHER INFORMATION CONTACT:
                                                                                                        affiliation of the interested person.
                                                  Closed: 1:00 p.m. to 2:00 p.m.                           In the interest of security, NIH has               Questions about this request for LOIs
                                                  Agenda: To review and evaluate grant                  instituted stringent procedures for entrance          should be directed to
                                                applications.                                           onto the NIH campus. All visitor vehicles,            NCIMATCHLabApps@nih.gov. James V.
                                                  Place: National Institutes of Health,                 including taxicabs, hotel, and airport shuttles       Tricoli tricolij@mail.nih.gov can also
                                                Natcher Building Forty-five, Natcher                    will be inspected before being allowed on
                                                Conference Center, Room E1, 45 Center
                                                                                                                                                              provide further information.
                                                                                                        campus. Visitors will be asked to show one            SUPPLEMENTARY INFORMATION: NCI–
                                                Drive, Bethesda, MD 20892.                              form of identification (for example, a
                                                  Open: 2:00 p.m. to 3:30 p.m.                                                                                MATCH aims to establish whether
                                                                                                        government-issued photo ID, driver’s license,
                                                  Agenda: To review the Division’s scientific
                                                                                                        or passport) and to state the purpose of their        patients with tumor mutations,
                                                and planning activities.                                                                                      amplifications or translocations in one
                                                                                                        visit.
                                                  Place: National Institutes of Health,                                                                       of the genetic pathways of interest are
                                                                                                           Information is also available on the
                                                Natcher Building Forty-five, Natcher                                                                          likely to derive clinical benefit (primary
                                                                                                        Institute’s/Center’s home page:
                                                Conference Center, Room E1, 45 Center
                                                Drive, Bethesda, MD 20892.
                                                                                                        www.niddk.nih.gov/fund/divisions/DEA/                 objective: Objective response; secondary
                                                                                                        Council/coundesc.htm., where an agenda and            objective: Progression-free survival of at
                                                  Contact Person: Brent B. Stanfield, Ph.D.,
                                                                                                        any additional information for the meeting            least 6 months) if treated with agents
                                                Director, Division of Extramural Activities,
                                                                                                        will be posted when available.                        targeting that specific pathway in a
                                                National Institutes of Diabetes and Digestive
                                                and Kidney Diseases, 6707 Democracy Blvd.               (Catalogue of Federal Domestic Assistance             single-arm design (see current arms
                                                Room 7323, MSC 5452, Bethesda, MD 20892,                Program Nos. 93.847, Diabetes,                        below).
                                                (301) 594–8843, stanfibr@niddk.nih.gov.                 Endocrinology and Metabolic Research;                    Patients with histologically
                                                                                                        93.848, Digestive Diseases and Nutrition
                                                  Name of Committee: National Diabetes and                                                                    documented solid tumors, lymphomas
                                                                                                        Research; 93.849, Kidney Diseases, Urology
                                                Digestive and Kidney Diseases Advisory                                                                        and multiple myeloma whose disease
                                                                                                        and Hematology Research, National Institutes
                                                Council; Kidney, Urologic and Hematologic                                                                     has progressed following at least one
                                                                                                        of Health, HHS)
                                                Diseases.                                                                                                     line of standard systemic therapy or for
                                                  Date: September 6, 2017.                                Dated: July 27, 2017.
                                                                                                                                                              whom no standard therapy exists are
                                                  Open: 1:00 p.m. to 3:00 p.m.                          David Clary,
                                                  Agenda: To review the Division’s scientific
                                                                                                                                                              eligible if they meet the eligibility
                                                                                                        Program Analyst, Office of Federal Advisory           criteria for the trial. Further information
                                                and planning activities.                                Committee Policy.
                                                  Place: National Institutes of Health,                                                                       about the NCI–MATCH trial may be
                                                Natcher Building Forty-five, Natcher                    [FR Doc. 2017–16192 Filed 8–1–17; 8:45 am]            found at http://ecog-acrin.org/trials/nci-
                                                Conference Center, Room F2, 45 Center                   BILLING CODE 4140–01–P                                match-eay131.
                                                Drive, Bethesda, MD 20892.                                                                                       The selected collaborating
                                                  Closed: 3:00 p.m. to 3:30 p.m.                                                                              laboratories may only act (i.e., refer
                                                  Agenda: To review and evaluate grant                  DEPARTMENT OF HEALTH AND                              patients) on any of the rare variant arms
                                                applications.                                           HUMAN SERVICES
sradovich on DSKBCFCHB2PROD with NOTICES




                                                                                                                                                              for which their assay reports actionable
                                                  Place: National Institutes of Health,                                                                       mutations of interest (aMOIs). The assay
                                                Natcher Building Forty-five, Natcher                    National Institutes of Health
                                                Conference Center, Room F2, 45 Center
                                                                                                                                                              must also report all exclusionary
                                                Drive, Bethesda, MD 20892.                              Request for Letters of Interest for NCI–              variants for the arm unless these occur
                                                  Contact Person: Brent B. Stanfield, Ph.D.,            MATCH Laboratories                                    at a frequency of >1% in cancer
                                                Director, Division of Extramural Activities,                                                                  patients.
                                                National Institutes of Diabetes and Digestive           SUMMARY:   The National Cancer Institute                 CLIA accredited/certified laboratories
                                                and Kidney Diseases, 6707 Democracy Blvd.               (NCI) in collaboration with the NCI                   located in the United States may be


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                                                                                      Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices                                                                                  35977

                                                considered for addition to the laboratory                                   • Lead contact name, address, email                                             variant arms (below) in the last 6
                                                network.                                                                        address, and telephone number                                               months
                                                                                                                            • CLIA certification number                                                 • Willingness to contact sites regarding
                                                Letter of Interest (LOI) and                                                • Assay name                                                                    results with a rare variant
                                                Collaboration Agreement                                                     • Brief description of assay                                                    potentially eligible for NCI MATCH
                                                                                                                              Æ Sensitivity and specificity for                                         • Willingness to sign a collaboration
                                                   Candidate laboratories should submit                                         SNVs, indels, CNV, fusions
                                                a letter of interest to                                                                                                                                     agreement with NCI and to share
                                                                                                                              Æ Method of analysis
                                                NCIMATCHLabApps@nih.gov stating:                                              Æ Platform and variant calling                                                data and publication rights
                                                                                                                            • Number of assays per month                                                • Which arms the laboratory is prepared
                                                • Statement of interest in the proposed                                     • Number of patients whose assay                                                to address.
                                                    activity                                                                    results would make them                                                   The arms that are included in the rare
                                                • Laboratory name                                                               potentially eligible for the rare                                       variant protocol amendment are:

                                                                                                                                                                                                                             MATCH subprotocol
                                                                                                              Rare variant candidate                                                                                             (agent)

                                                AKT1 mut ......................................................................................................................................................     EAY131–Y (AZD5363).
                                                NF2 loss ........................................................................................................................................................   EAY131–U (Defactinib).
                                                MET amplification .........................................................................................................................................         EAY131–C1 (Crizotinib).
                                                BRAF V600 ...................................................................................................................................................       EAY131–H (Dabrafenib + Trametinib).
                                                SMO/PTCH1 .................................................................................................................................................         EAY131–T (Vismodegib).
                                                BRAF non V600 ............................................................................................................................................          EAY131–R (Trametinib).
                                                EGFR T790M ................................................................................................................................................         EAY131–E (AZD9291).
                                                ALK translocation ..........................................................................................................................................        EAY131–F (Crizotinib).
                                                cKIT mutation ................................................................................................................................................      EAY131–V (Sunitinib).
                                                EGFR mutation .............................................................................................................................................         EAY131–A (Afatinib).
                                                ROS1 translocation .......................................................................................................................................          EAY131–G (Crizotinib).
                                                GNAQ/GNA11 ...............................................................................................................................................          EAY131–S2 (Trametinib).
                                                MET exon 14 skipping ..................................................................................................................................             EAY131–C2 (Crizotinib).
                                                NTRK fusions ................................................................................................................................................       EAY131 Z1E (Loxo101).
                                                MTOR mutations ...........................................................................................................................................          EAY131–L (MLN0128).
                                                TSC1 or TSC2 mutations .............................................................................................................................                EAY131–M (MLN0128).
                                                CCND 1,2,3 amplifications ...........................................................................................................................               EAY131–Z1B (Palbociclib).
                                                CDK4 or CDK6 amplification ........................................................................................................................                 EAY131–Z1C (Palbociclib).
                                                DDR2 mutation .............................................................................................................................................         EAY131–X (Dasatinib).



                                                  Following an acceptable eligibility                                       Æ 99% reproducibility between                                                  • Academic laboratories must be
                                                review to the NCI MATCH screening                                             sequencers (if more than one                                              located at a center that participates in
                                                committee, the laboratory would                                               sequencer is used) and between                                            NCI MATCH.
                                                execute a confidentiality agreement                                           operators                                                                    • As it is important that the dataset
                                                with the NCI and will be provided with                                      Æ Lower limit of detection for SNV,                                         used for analysis in NCI MATCH be as
                                                a detailed list of eligibility and                                            indels, CNV must be stated.                                               robust as possible, the laboratory NGS
                                                exclusion variants for arms in which the                                                                                                                test will require qualification, during
                                                                                                                              Laboratories must supply the                                              which the performance of the laboratory
                                                lab has interest. The lab would then be
                                                                                                                            following information in their                                              will be compared with the NCI–MATCH
                                                required to submit an application
                                                                                                                            application:                                                                central laboratory test to ensure good
                                                within 3 months for review by the NCI–
                                                MATCH steering committee. Candidate                                         Æ Lower limit of % tumor accepted, and                                      agreement with that assay. Concordance
                                                laboratories will be required to meet the                                     whether (and which) enrichment                                            between the results from each lab and
                                                following general requirements:                                               procedures are employed                                                   results of the NCI MATCH NGS assay
                                                  • Testing must be performed in a                                          Æ Whether the lab archives images of                                        run on an archived specimen will be
                                                CLIA-certified or -accredited laboratory                                      slides from the tumor                                                     tracked; if concordance falls below 90%
                                                located in the United States.                                               Æ Whether the lab also runs germline as                                     for SNVs and indels, or 80% for CNVs,
                                                  • Assays must be on tumor tissue                                            well as tumor with the assay (a                                           the laboratory must be willing to
                                                only (including lymphoma and                                                  simultaneous germline sequencing is                                       address these issues with the NCI
                                                myeloma). Assays using circulating                                            not required by NCI MATCH)                                                MATCH team. If they cannot be
                                                nucleic acids will not be accepted at                                                                                                                   addressed to the satisfaction of the NCI
                                                                                                                            Æ A detailed description of assay
                                                this time.                                                                                                                                              MATCH team, the laboratory may be
                                                                                                                              procedures, including starting
                                                  • Laboratory NGS panels must be                                                                                                                       eliminated from participation in NCI
                                                                                                                              material, extraction of nucleic acids,
                                                analytically and clinically validated,                                                                                                                  MATCH.
                                                                                                                              quality assurance, quality metrics,
                                                with performance characteristics as
                                                                                                                              data analysis and filters must be                                            • Laboratories shall NOT advertise
                                                follows:                                                                                                                                                that they are screening laboratories for
                                                                                                                              supplied.
sradovich on DSKBCFCHB2PROD with NOTICES




                                                Æ Specificity at least 99% for single                                                                                                                   MATCH eligibility. Any press release or
                                                  nucleotide variants, indels                                                 • Laboratory NGS test panels must                                         public disclosure requires clearance by
                                                Æ Sensitivity at least 95% for single                                       interrogate actionable mutations of                                         NCI and NCI MATCH.
                                                  nucleotide variants, indels                                               interest (aMOIs) required for enrollment                                       • Laboratories must agree to use the
                                                Æ Sensitivity of 90% for copy number                                        into the Rare Variant Arms (see table                                       existing workflow established by the
                                                  variants (state fold of copy number                                       above). Applicant laboratories must                                         NCI MATCH trial to identify patients for
                                                  variants that can be detected with                                        state the MATCH arms in which they                                          the Rare Variant Arms. This includes
                                                  90% sensitivity)                                                          would like to participate.                                                  use of the MATCH Rare Variant


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                                                35978                      Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices

                                                template to identify aMOIs for                            4. Applications that have not been                  DEPARTMENT OF HEALTH AND
                                                submission to MATCHbox.                                 submitted within 3 months of                          HUMAN SERVICES
                                                Æ Laboratory results of NGS assays done                 notification of acceptance will be de-
                                                   for clinical care will be the subject of             activated, and a new LOI must then be                 National Institutes of Health
                                                   this initiative. There is no funding for             submitted if the laboratory wishes to
                                                   ‘‘screening’’ a patient for MATCH.                                                                         National Cancer Institute; Notice of
                                                                                                        participate in NCI MATCH.
                                                Æ Laboratories must notify NCI MATCH                                                                          Closed Meeting
                                                                                                          5. DO NOT send a full application
                                                   sites that the laboratory results would
                                                                                                        until you are invited to do so.                          Pursuant to section 10(d) of the
                                                   potentially allow the patient to be
                                                                                                          Review criteria for LOI:                            Federal Advisory Committee Act, as
                                                   eligible for NCI MATCH.
                                                Æ Laboratories must track how many                                                                            amended (5 U.S.C. Appendix 2); notice
                                                                                                          • Laboratory is a CLIA certified or                 is hereby given of the following
                                                   assays per week detect rare variants                 accredited laboratory within the United
                                                   that could make a patient eligible for                                                                     meeting.
                                                                                                        States.                                                  The meeting will be closed to the
                                                   NCI MATCH.
                                                   Æ If the clinician presents the                        • Academic laboratories must have                   public in accordance with the
                                                      MATCH study and the patient is                    NCI MATCH open at their site.                         provisions set forth in sections 552b(c)
                                                      eligible and desires to enter the                   • Laboratory has adequate sensitivity,              (4) and 552b(c) (6), Title 5 U.S.C., as
                                                      study, the laboratory must agree to               specificity.                                          amended. The purpose of this meeting
                                                      fill out a spreadsheet that can be                                                                      is to evaluate requests for preclinical
                                                                                                          • Laboratory tests tumor tissue for                 development resources for potential
                                                      used to put the results into the
                                                                                                        rare variants as described in NCI                     new therapeutics for the treatment of
                                                      informatics system that assigns
                                                      treatment in NCI MATCH                            MATCH.                                                cancer. The outcome of the evaluation
                                                      (MATCHbox).                                         • Laboratory agrees to provide needed               will provide information to internal NCI
                                                   Æ Laboratories must have a way to                    information for evaluation of the                     committees that will decide whether
                                                      answer questions from NCI MATCH                   analytical validity of the test.                      NCI should support requests and make
                                                      sites about their assay and must                    • Laboratory is likely to refer at least            available contract resources for
                                                      have a contact person for optimal                                                                       development of the potential
                                                                                                        100 patients to NCI MATCH based on
                                                      communication with the NCI                                                                              therapeutic to improve the treatment of
                                                                                                        detection of rare variants in the past.
                                                      MATCH team.                                                                                             various forms of cancer. The research
                                                   • Prior to participation, laboratories                 • Laboratory agrees to contact sites                proposals and the discussions could
                                                must enter into a collaboration                         regarding NCI MATCH eligibility.                      disclose confidential trade secrets or
                                                agreement with NCI. A sample                              • Laboratory agrees to a collaboration              commercial property such as patentable
                                                agreement is available upon request. As                 with NCI as detailed above.                           material, and personal information
                                                part of such a collaboration agreement,                                                                       concerning individuals associated with
                                                laboratories must agree to provide the                    Review criteria for full application:
                                                                                                                                                              the proposed research projects, the
                                                licensing rights described in the CTEP                    • Laboratory NGS assay interrogates                 disclosure of which would constitute a
                                                IP Option to the Pharmaceutical                         inclusionary and all exclusionary                     clearly unwarranted invasion of
                                                Collaborators who provided agents for                   variants for arms in which the                        personal privacy.
                                                the NCI MATCH trial (https://                           laboratory will participate.                            Name of Committee: National Cancer
                                                ctep.cancer.gov/branches/rab/                             • Laboratory supplies evidence that                 Institute Special Emphasis Panel; Jun2017
                                                intellectual_property_optionto_                         the assay meets analytical requirements               Cycle 26 NExT SEP Committee Meeting.
                                                collaborators.htm), as well as agree to                 as detailed above.                                      Date: August 31, 2017.
                                                the data sharing and publication rights                                                                         Time: 8:30 a.m. to 4:30 p.m.
                                                consistent with those agreements.                         • Laboratories are capable of                         Agenda: To evaluate the NCI Experimental
                                                   • No reimbursement for these                         contacting clinical sites, tracking                   Therapeutics Program Portfolio.
                                                activities (testing or notification of sites            activity, and of referring at least 100                 Place: National Institutes of Health, 9000
                                                of NCI MATCH eligibility) exists.                       patients to the study based on detection              Rockville Pike, Building 31, Wing C, 6th
                                                                                                                                                              Floor, Conference Room 10, Bethesda, MD
                                                   Qualified laboratories serving                       of rare variants in the past.                         20892.
                                                underserved populations are                               • Laboratories agree to execute a                     Contact Persons: Barbara Mroczkowski,
                                                encouraged to participate.                              collaboration agreement with NCI, as                  Ph.D., Executive Secretary, Discovery
                                                   How to apply:                                                                                              Experimental Therapeutics Program,
                                                   1. Submit letter of interest (LOI) as                well as to data sharing and sharing
                                                                                                                                                              National Cancer Institute, NIH, 31 Center
                                                described above under ‘‘Letter of                       publication rights.
                                                                                                                                                              Drive, Room 3A44, Bethesda, MD 20817
                                                Interest and Collaboration Agreement’’                    • Laboratories agree to abide by the                (301) 496–4291, mroczkoskib@mail.nih.gov.
                                                to NCIMATCHLabApps@nih.gov.                             procedures in place for the MATCH                       Toby Hecht, Ph.D., Executive Secretary,
                                                   2. LOIs will be accepted until January               study and to collaborate fully with the               Development Experimental Therapeutics
                                                31, 2018 at 5:00 p.m. Eastern Time. LOIs                MATCH team.                                           Program, National Cancer Institute, NIH,
                                                will be reviewed on a monthly basis,                                                                          9609 Medical Center Drive, Room 3W110,
                                                                                                          For more information, contact                       Rockville, MD 20850, (240) 276–5683,
                                                with those arriving by the 15th day of
                                                                                                        NCIMATCHLabApps@nih.gov.                              toby.hecht2@nih.gov.
                                                the month being reviewed and answered
                                                by the 15th day of the following month.                   Dated: July 20, 2017.                               (Catalogue of Federal Domestic Assistance
                                                   3. Notification of acceptance, non-                                                                        Program Nos. 93.392, Cancer Construction;
sradovich on DSKBCFCHB2PROD with NOTICES




                                                                                                        James V. Tricoli,
                                                acceptance or questions from Steering                                                                         93.393, Cancer Cause and Prevention
                                                                                                        Chief, Diagnostic Biomarkers and Technology           Research; 93.394, Cancer Detection and
                                                Committee will be sent to the                           Development Branch, Cancer Diagnosis                  Diagnosis Research; 93.395, Cancer
                                                designated contact person as soon as the                Program, Division of Cancer Treatment and             Treatment Research; 93.396, Cancer Biology
                                                LOI has been reviewed. This                             Diagnosis, National Cancer Institute.                 Research; 93.397, Cancer Centers Support;
                                                notification will include further                       [FR Doc. 2017–16203 Filed 8–1–17; 8:45 am]            93.398, Cancer Research Manpower; 93.399,
                                                instructions if a full application is                   BILLING CODE 4140–01–P
                                                                                                                                                              Cancer Control, National Institutes of Health,
                                                invited.                                                                                                      HHS)



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Document Created: 2017-08-02 07:09:31
Document Modified: 2017-08-02 07:09:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesLOIs should be submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH) on or before 5:00 p.m. EST on January 31, 2018.
ContactQuestions about this request for LOIs should be directed to [email protected] James V. Tricoli [email protected] can also provide further information.
FR Citation82 FR 35976 

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