Immuno-Oncology Translation Network (IOTN): Cancer Immunotherapy Research Projects (U01 Clinical Trial Not Allowed) | RFA CA 19 015

Frequently Asked Questions (FAQs)

What is the name of this funding opportunity?

The opportunity is titled "The Immuno-Oncology Translation Network (IOTN): Cancer Immunotherapy Research Projects (U01 Clinical Trial Not Allowed)" and it is associated with the NIH Funding Opportunity Announcement RFA-CA-19-015.

Which agency is offering this opportunity?

The originating agency is the National Institutes of Health (NIH).

What type of award mechanism is being used?

This opportunity uses the U01 cooperative agreement mechanism. A cooperative agreement generally involves substantial scientific involvement by NIH program staff compared with a standard research project grant.

Is this a discretionary funding opportunity?

Yes. The opportunity summary describes it as a discretionary funding opportunity.

What is the overall purpose of this program?

The program is designed to speed up practical, near-term advances in cancer immunotherapy by supporting translational immuno-oncology research that moves discoveries about immune-tumor interactions toward strategies to better treat established adult cancers or prevent cancers from developing.

How does this opportunity connect to the Cancer Moonshot?

This FOA is part of the Beau Biden Cancer Moonshot initiative and aligns with the Cancer Moonshot Blue Ribbon Panel scientific priority (Recommendation B) calling for a dedicated translational science network built around immunotherapy approaches for adult cancers.

What does "Immuno-Oncology Translation Network (IOTN)" mean in practice?

It means funded projects are intended to operate as components of a broader, coordinated network rather than as isolated, stand-alone efforts. The emphasis is on multidisciplinary team science, collaboration across projects, sharing insights and resources, and coordinating work to accelerate progress in immunotherapy translation.

What kinds of research projects does the FOA support?

The FOA supports organ site-specific cancer immunotherapy research projects focused on translational immuno-oncology, with the goal of producing near-term, practical advances that are positioned to move toward future clinical translation.

What is meant by "organ site-specific" in this context?

Based on the FOA description, projects should focus on immunotherapy research related to a specific organ site (i.e., a particular cancer site/disease area) while still contributing to the broader IOTN network objectives.

Is the research expected to be preclinical or clinical?

The work is expected to be largely preclinical, but strongly clinically relevant. Projects should use models, experimental systems, and endpoints that meaningfully reflect human disease and could plausibly support future clinical translation.

Are clinical trials allowed under this FOA?

No. The FOA explicitly states "Clinical Trial Not Allowed," reinforcing that the primary deliverables should be translational and preclinical advances rather than interventional studies in human participants.

What are the scientific goals of the overall network?

The overall IOTN goals include understanding innate and adaptive immune mechanisms that influence tumor growth and progression, identifying and validating new immune targets, and testing novel immune-based treatments and rational combination approaches aimed at producing durable anti-cancer immune responses.

Does the FOA encourage combination approaches?

Yes. The FOA description specifically mentions rational combination approaches, such as pairing immunotherapies with standard treatments or other modalities, with the aim of achieving durable anti-cancer immune responses.

What does NIH involvement typically look like in a U01 cooperative agreement?

Because this is a cooperative agreement, NIH program staff typically have substantial scientific involvement. Funded teams should be prepared for active coordination, milestone-driven progress, and participation in network-level activities that integrate efforts across sites and disease areas.

Is the program intended to fund independent, stand-alone projects?

No. The FOA is designed to build a coordinated network of multidisciplinary teams. The intent is that projects function as parts of a broader ecosystem that shares information and resources to accelerate translational progress.

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations and governmental entities, including state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.

Are tribal governments and tribal organizations eligible?

Yes. Eligible applicants include Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments). The FOA also highlights Indian/Native American tribal governments that are not federally recognized as an additional eligible applicant type.

Are U.S. territories or possessions eligible to apply?

Yes. The FOA highlights U.S. territories or possessions as eligible applicant types.

Are specific types of minority-serving institutions called out as eligible?

Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and tribally controlled colleges and universities.

Can non-U.S. (foreign) institutions apply as the applicant organization?

No. Non-U.S. (foreign) institutions are not eligible to apply as applicant organizations under this FOA.

Can a U.S. organization include non-U.S. components?

No. The FOA states that non-U.S. components of U.S. organizations are not eligible.

Are any foreign collaborations allowed at all?

Yes. While foreign institutions cannot apply as the applicant organization and non-U.S. components are not eligible, the FOA states that foreign components (as defined under NIH policy) are allowed. This implies a U.S. applicant can include well-justified foreign collaborations or elements within the project structure when consistent with NIH policy.

What is the award ceiling listed for this opportunity?

The opportunity summary lists an award ceiling of $500,000.

What is the activity category or area listed for this opportunity?

The activity category is listed under environment and health.

What was the original closing date for applications?

The original closing date listed in the summary is February 8, 2019.

What are the key deliverables this FOA is aiming for?

Based on the description, the FOA is aiming for translational and preclinical advances that are clinically grounded, help identify and validate immune targets, and support the development and testing of novel immune-based therapies and rational combinations, all within a collaborative network structure intended to accelerate movement toward the clinic.

What does "translational immuno-oncology" mean in the context of this FOA?

In this FOA, translational immuno-oncology refers to pushing discoveries about how the immune system interacts with tumors toward practical strategies that can more effectively treat established adult cancers or help prevent cancers from developing, using preclinical work that is tightly connected to clinical relevance.

Does the FOA focus on adult cancers?

Yes. The description repeatedly frames the network and its immunotherapy approaches around adult cancers.

How should applicants think about models and endpoints for supported projects?

The FOA expects projects to use models, experimental systems, and endpoints that meaningfully reflect human disease and could plausibly support future clinical translation, even though clinical trials are not permitted under this mechanism.

What does it mean that projects will "operate as components" of the broader network?

It indicates the projects are expected to participate in network-level coordination and collaborative activities, contribute to shared goals, and integrate their efforts with other teams and disease areas rather than functioning as isolated research efforts.