Administrative Supplements for P30 Cancer Centers Support Grants (CCSG) to Stimulate Research in Immunotherapy and Tumor Microenvironment in HIV/AIDS Cancer Patients at NCI-designated Cancer Centers
Key Dates
Release Date: January 9, 2020
Request Receipt Due: March 31, 2020
Earliest Anticipated Start Date for Awards: July 1, 2020
Purpose
The National Cancer Institute (NCI) announces an opportunity for supplemental funding to identify and advance immunotherapy translational approaches for HIV/AIDS individuals with cancer. The primary goals will be the discovery and characterization of immunotherapeutic targets, the development of new immunotherapy treatment approaches, and the improved understanding of the immunosuppressive tumor microenvironment, all in order to advance new, more effective immune-based therapeutic regimens for patients with HIV/AIDS-related cancers.
All NCI-Designated Cancer Centers are eligible for funding. A letter of intent is not required; a full proposal of no more than 6 pages must be submitted by the request receipt date to the NCI Office of Cancer Centers. Funding is contingent upon NCI approval of the proposal, which will include both a scientific and budgetary evaluation. Only one supplement will be allowed per institution. These administrative supplements are designed to address focused areas of challenge such as mechanisms of immune evasion, model development, or validation of a single target.
Background
Human immunodeficiency virus (HIV)-infected individuals are at increased risk for developing several cancers. Despite the success of combination antiretroviral therapy (cART) in suppressing HIV and improving patients’ quality of life, cART does not lead to eradication of the virus. Cellular immunity is central in controlling HIV replication, and the focus now has shifted more to control of viral replication rather than eradication. Several recent studies have demonstrated the safety and feasibility of immunotherapeutic approaches for successful treatment of some cancers in non-HIV infected individuals. Effective strategies include the use of antibodies to check point inhibitory molecules such as PD-1 and antibodies that targets cytotoxic T-lymphocyte associated antigen-4 (CTLA-4) which are regulators of T-cell function. Other reported approaches include the use of chimeric antigen receptor (CAR) T-cells for treatment of adults with relapsed or refractory non-Hodgkin lymphoma patients. The capability of CAR T-cells for long-term engraftment and immune surveillance was recently shown in a large animal preclinical model for HIV/AIDS.
Since HIV adopts numerous strategies to evade immune surveillance, it is of importance to determine if people living with HIV (PLWH) will respond to anticancer immunotherapy modalities in a fashion similar to non-HIV infected individuals in the general population. The ultimate goal to treating cancer is dependent on a safe and effective immunotherapeutic modality concurrently with enhancing a tumor microenvironment that promotes T cell activation and infiltration into premalignant or cancerous tissue. The success rates of first generation cancer immunotherapies, such as checkpoint inhibitors, genetically engineered T-cells, and new immune activators, have improved remarkably over the past 10 years resulting in durable, long term survival, and in some cases cures for a subset of patients with advanced cancers such as melanoma, blood and lung cancers. However, it is unknown whether PLWH are good candidates for immunotherapy, since they are often excluded from cancer immunotherapy studies. Little is known about their response to immunotherapy; if their tumor microenvironment is more hostile and prevents T-cell activation and infiltration; and if they can achieve similar results as the non-HIV-infected cancer patients.
Scope
The primary goals will be the discovery and characterization of immunotherapeutic targets, the development of new immunotherapy treatment approaches, and the improved understanding of the immunosuppressive tumor microenvironment, all in order to advance new, more effective immune-based therapeutic regimens for patients with HIV/AIDS-related cancers. This FOA is not designed for support of clinical trials.
Eligible Institutions
Cancer Centers whose P30 CCSG will be in a cost-extension at the time the award is made in FY20 are not eligible for this supplement.
Number of Applications
Only one application per institution is allowed. Each application must include a cover letter from the NCI-Cancer Center Director with concurrence from the Authorized
Organization Official (AOR).
Letter of Intent
A letter of intent is not required for this supplement.
Terms and Conditions of Funding and Allowable Costs
The budget should justify all the direct and indirect costs. Supplements are for 2 years only, although a one-year no-cost extension will be allowed. We anticipate that up to 8 to 9 awards of no more than $250,000 total cost each will be made in the 2020 fiscal year. Any proposal that cannot be completed within the 2-year time frame will be viewed as non-responsive. Allowable costs include funding for the Project Leader of the study (maximum of 20% effort), who must be a member of the NCI-designated cancer center; funding for required expertise to complete this project; and costs for supplies. The purchase of large pieces of equipment through this supplement will not be permitted.
Supplement Award Application Procedures
1. Cover Letter
A cover letter should accompany each application and include the following:
a. Request for an administrative supplement to support the project
b. Title of the supplement
c. P30 grant number
d. Contact information for the Cancer Center Director and the Project Leader
e. Signatures of the Cancer Center Director and the Authorized Organization Representative (AOR)
2. Application
a. Standard PHS 398 (pages: 1-5)
i. Item 2: check yes and provide the title indicated in the cover letter, 1.b.
ii. Item 7A-8B, denote the direct and total costs for the project.
iii. The AOR must sign the face page.
iv. Include a detailed budget description.
v. Provide NIH biographical sketches for the P30 Principal Investigator and the Project Leader.
3. Summary of the Project Proposed
The applicant should attach a summary of the project including a description of aims; specific approach to be used to complete this project; investigators; and environment where the work will be performed. A full budget with justification should be included. A statement of how the proposed project would meet the NIH HIV/AIDS Research Priorities as listed in the NOT-OD-15-137. It should explain which high priority topic or topics be addressed. General projects focusing, for example, on EBV, HPV, KSHV or other oncogenic viruses or HIV alone are not eligible for support under this supplement award.
4. Justification of Staff
Provide NIH biographical sketches of all key personnel, including investigators who will
provide immunological, model development, sequencing and biostatistical analyses, if required. Note that in order to qualify for a supplement, the name of the Project Leader must be proposed at the time of submission.
Application Submission
Applications may be submitted as a signed, scanned PDFs to Ms. Nga Nguyen at nga.nguyen2@nih.gov by 5:00 p.m. (local time) on the receipt date.
Evaluation Criteria
Supplements will be administratively evaluated by NCI staff with appropriate expertise. There will not be a secondary review process.
Awards
Awards will be based on responsiveness to the goals of this announcement and the availability of funds.
Reporting Requirements
As part of the annual progress report for either the parent NCI Cancer Center Support Grants include information on what has been accomplished via the administrative supplement during the funding period. A copy of the annual progress report for the administrative supplement should also be sent to Dr. Hasnaa Shafik by email at shafikh@mail.nih.gov.
Questions
Please contact Dr. Hasnaa Shafik (telephone: 240-276-5600; Email: shafikh@mail.nih.gov) for questions related to the supplement.