Notice of Change to RFA-CA-17-005 "Cancer Immune Monitoring and Analysis Centers (CIMACs) (U24)" for Addition of a Pediatric CIMAC

Notice Number: NOT-CA-17-024

Key Dates
Release Date:   January 31, 2017

Related Announcements
RFA-CA-17-005
NOT-CA-17-025

Issued by
National Cancer Institute (NCI)

Purpose

This Notice is to inform the scientific community that the National Cancer Institute (NCI) is amending  RFA-CA-17-005 "Cancer Immune Monitoring and Analysis Centers (CIMACs) (U24)” to support an additional CIMAC to be focused on biospecimens from pediatric immunotherapy trials (the Pediatric CIMAC).  

CIMACs (covered by RFA-CA-17-005) will form a network together with Cancer Immunologic Data Commons (CIDAC) covered by the companion funding opportunity announcement (FOA), RFA-CA-17-006. By inclusion of the Pediatric CIMAC, the CIMACs-CIDC network will be able to accommodate correlative studies using specimens from clinical trials in pediatric patient populations.

The following Sections of RFA-CA-17-005 are revised accordingly:

Part 1: Overview Information

Section 1. Funding Opportunity Purpose

Currently reads:

This National Cancer Institute (NCI) funding opportunity announcement (FOA) solicits applications for multidisciplinary Cancer Immune Monitoring and Analysis Centers (CIMACs) that will serve as the main units of the Network for correlative studies in clinical trials involving immunotherapy. The Network will encompass two to three CIMACs (to be supported by this FOA) and a single Cancer Immunologic Data Commons (CIDC) (to be supported by the companion FOA, RFA-CA-17-006) forming a CIMACs-CIDC Network.

Modified to read:

This National Cancer Institute (NCI) funding opportunity announcement (FOA) solicits applications for multidisciplinary Cancer Immune Monitoring and Analysis Centers (CIMACs) that will serve as the main units of the Network for correlative studies in clinical trials involving immunotherapy. The Network will encompass two to three CIMACs (to be supported by this FOA) as well as an additional CIMAC focusing on pediatric immunotherapy (the Pediatric CIMAC), and a single Cancer Immunologic Data Commons (CIDC) (to be supported by the companion FOA, RFA-CA-17-006) forming a CIMACs-CIDC Network.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Additional Background section:

Additional research on the immunogenomics and immunotargets for childhood and adolescent cancers is needed. Despite progress, for most patients with high-risk or refractory childhood cancers there is no effective immunotherapeutic option. The addition of a CIMAC focusing exclusively on pediatric cancers is part of multi-component effort by NCI to accelerate the pace at which further effective immunotherapies are realized for childhood cancers. It is likely that the development of successful pediatric immunotherapy will require a distinctive focus when compared to immunotherapy for adult cancers. For pediatric cancers, there will likely be increased focus on approaches designed at targeting the immune system towards aberrantly expressed embryonal antigens using CAR T cells, bispecific T cell engaging antibodies, antibody-drug conjugates, and other approaches.  Distinctive laboratory tests may apply to clinical trials involving these and other pediatric immunotherapy agents (e.g., embryonal antigen expression, FcR genotyping, KIR/KIR ligand genotyping, etc.). The pediatric CIMAC will be well placed to both recognize these research opportunities and to perform the laboratory studies needed so that optimum information for advancing pediatric immunotherapy is obtained from pediatric clinical trials.

Main Objectives and Key Requirements for the Cancer Immune Monitoring and Analysis Centers (CIMACs)

Sources of Clinical Specimens for CIMACs

Currently reads:

  • National Clinical Trials Network (NCTN);
  • Experimental Therapeutics Clinical Trials Network (ETCTN);
  • Cancer Immunotherapy Trials Network (CITN);
  • Pediatric Brain Tumor Consortium (PBTC) Pediatric phase I and II Network; and
  • Adult Brain Tumor Consortium (ABTC)

Modified to read:

  • National Clinical Trials Network (NCTN);
  • Experimental Therapeutics Clinical Trials Network (ETCTN);
  • Cancer Immunotherapy Trials Network (CITN);
  • Pediatric Brain Tumor Consortium (PBTC) Pediatric phase I and II Network; and
  • Adult Brain Tumor Consortium (ABTC)
  • Children’s Oncology Group Phase 1 / Pilot Consortium

Sources of Clinical Specimens for CIMACs

Currently reads:

The specimens for CIMAC biomarker assays will be derived from Phase 1 and 2 immunotherapy trials. In the event of a combined Phase 2/3 trial, the CIMAC award will support only the Phase 2 component. Phase 3 trials are outside the scope of this FOA. If there is a need for correlative studies for the Phase 3 segment, additional funds would have to be obtained from outside the CIMACs award for such study.

Modified to read:

The specimens for CIMAC biomarker assays will be derived from Phase 1 and 2 immunotherapy trials. In the event of a combined Phase 2/3 trial, the CIMAC award will support only the Phase 2 component. Phase 3 trials are outside the scope of this FOA. If there is a need for correlative studies for the Phase 3 segment, additional funds would have to be obtained from outside the CIMACs award for such study. For the Pediatric CIMAC, specimens may be derived from phase 1 and 2 immunotherapy trials as well as from phase 3 trials when the specimens can help to address important pediatric immunotherapy questions.

Section II. Award Information

Funds Available and Anticipated Number of Awards

Currently reads:

The NCI intends to fund up to three (3) Cancer Immune Monitoring and Analysis Center (CIMAC) awards, corresponding to a set-aside of $4.2 million (in direct costs) in fiscal year 2017.

Modified to read:

The NCI intends to fund up to four (4) Cancer Immune Monitoring and Analysis Center
(CIMAC) awards (including the Pediatric CIMAC), corresponding to a set-aside of $5.8M (in direct costs) in fiscal year 2017.

Award Budget

Currently reads:

Each CIMAC application budget is limited to no more than $1.4 million in direct costs for any budget year.

Applications for CIMACs not focused entirely on pediatric cancers may request budgets up to $1.6 million in direct costs for any budget year. The amounts budgeted, however, must include $0.2 million in direct costs that will be dedicated to applying the proposed analyses to pediatric specimens

Applications for Pediatric CIMAC, i.e., those focused entirely on analyses specific for pediatric specimens, may request budgets up to $1 million per year in direct costs. 

Section IV. Application and Submission Information

R&R Budget

Additional bullet inserted after bullet for "Specialized assays reflecting the CIMAC's unique technical capabilities":

  • For Pediatric CIMACs, the same assumptions applied to the other CIMACs should be used, taking into consideration that the total direct costs are reduced. (Note: Depending upon the complexity of the assays performed on pediatric specimens, the number of specimens that will actually be studied may be greater than that used for budgeting purposes.)

Additional bullet inserted after "Travel Funds" bullet:

  • Pediatric specimens: CIMAC applicants not focusing entirely on pediatric cancers should include $0.2 million annually in their budget request that will be dedicated to the evaluation of pediatric specimens using the assays of these CIMACs.

PHS 398 Research Plan

Research Strategy:
Sub-section (A) Significance and Innovation

Additional bullet inserted after the last bullet in this section:

  • For the Pediatric CIMAC, describe the distinctive aspects of pediatric immunotherapy and how the research team will address these through its technical capabilities and its research aims.

All other aspects of RFA-CA-17-005 remain unchanged.

Inquiries

Please direct all inquiries to:  

Magdalena Thurin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5973
E-mail: thurinm@mail.nih.gov

Malcolm A. Smith, M.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6087
E-mail: Malcolm.Smith@nih.gov