Coordinating Center for Canine Immunotherapy Trials and Correlative Studies (U24) | RFA CA 17 002

Opportunity Information: Apply for RFA CA 17 002

The Coordinating Center for Canine Immunotherapy Trials and Correlative Studies (U24) funding opportunity (RFA-CA-17-002) is a National Institutes of Health, National Cancer Institute (NCI) cooperative agreement designed to fund a single coordinating hub for a larger network of canine cancer immunotherapy studies. The broader network is made up of companion awards under a related U01 announcement (RFA-CA-17-001) that will run clinical trials in pet dogs that naturally develop cancer (spontaneous tumors) and will carry out laboratory correlative studies tied directly to those trials. The idea is to use naturally occurring cancers in dogs, treated in real-world veterinary settings, to generate clinically relevant immunotherapy data and biological insights that can inform both veterinary and human cancer research, with the coordinating center serving as the operational and scientific backbone that keeps the network aligned, consistent, and productive.

At its core, the U24 coordinating center is expected to function as the network-wide organizer and technical resource. A major responsibility is providing statistical support for the design, conduct, and analysis of the clinical trials, helping ensure the studies are appropriately powered, endpoints are defined clearly, analyses are prespecified, and results can be interpreted with confidence. Beyond statistics, the coordinating center is tasked with helping develop, harmonize, and standardize clinical trial protocols across the participating U01 sites. This includes building consistency around eligibility criteria, treatment plans, response assessments, specimen collection schedules, and reporting requirements so data from multiple locations can be combined and compared without introducing avoidable variation.

Another central requirement is laboratory standardization for immune monitoring and other correlative assays. Because immunotherapy trials depend heavily on understanding immune responses and biomarkers, the coordinating center is expected to assist with developing and standardizing immune monitoring assays and related laboratory methods used across the network. That standardization role is meant to improve reproducibility and make it more feasible to interpret cross-study patterns, such as how immune signatures relate to clinical response, resistance, or toxicity. These correlative studies are positioned as an integrated component of the clinical trials rather than an afterthought, meaning the coordinating center helps keep the laboratory science tightly linked to the clinical questions being tested.

The announcement also emphasizes hands-on implementation support for the actual conduct of immunotherapy and combination-agent trials, including practical support tied to accrual (enrollment of eligible canine patients). This points to a real operational mission: helping sites open studies efficiently, keep them running smoothly, and enroll dogs in a timely way, which is often one of the biggest challenges in multi-site trials. Since these trials involve immunotherapies and combinations, the coordinating center is also expected to help track and manage immune-related adverse events in a consistent manner across the network, improving safety oversight and ensuring that toxicity reporting is complete and comparable across sites.

A major deliverable is comprehensive data management. The coordinating center must manage clinical and correlative data coming from all U01 sites and their collaborators, which includes capturing, curating, quality-checking, and maintaining datasets that combine clinical outcomes, laboratory results, and adverse event information. This kind of centralized data coordination is intended to support accurate analyses, enable cross-trial comparisons, and increase the scientific value of specimens and results generated by the network. Alongside data coordination, the FOA calls for facilitating sharing of agents, specimens, and data, which signals an expectation that the coordinating center will help establish the processes and infrastructure needed for distribution and access, such as common standards, tracking systems, and policies that enable collaboration while protecting study integrity.

Structurally, the coordinating center is also expected to create and support an ad hoc steering committee that brings together the expertise needed to guide the network. This committee is meant to include both internal and external experts, specifically including the PDs/PIs of the U01 projects, representatives of the NCI Comparative Oncology Program (COP), and the NCI Program Official. The purpose of this steering function is to ensure coordination of priorities, resolve operational or scientific issues as they arise, and keep the network focused on achieving the overall goals of the canine immunotherapy trial effort.

The FOA is explicitly integrated with the NCI Comparative Oncology Program (COP) within NCI's Center for Cancer Research, positioning the coordinating center as an integral component of NCI's comparative oncology strategy rather than a standalone administrative unit. In practice, this means close collaboration with COP leadership and alignment with NCI expectations for cooperative agreements, where NIH/NCI staff typically have substantial scientific and programmatic involvement compared to standard grants.

In terms of administrative details, this is a discretionary funding opportunity using a cooperative agreement mechanism (U24), reflecting the planned, networked nature of the work and the active partnership with NCI. The opportunity was created December 16, 2016, with an original closing date of March 7, 2017. The anticipated number of awards was one, with an award ceiling of $350,000, indicating NCI intended to fund a single coordinating center to serve the entire U01 clinical trial network. Eligibility is broad and includes many types of U.S. organizations and governments, such as state and local governments, public and private institutions of higher education, tribal governments and organizations, nonprofits with or without 501(c)(3) status, for-profit entities (other than small businesses), and small businesses, with additional eligibility guidance referenced in the full announcement.

Overall, the opportunity funds a single central organization to provide the statistical, protocol, assay, operational, data, and governance infrastructure needed for a multi-site network of canine immunotherapy clinical trials and correlative studies. The coordinating center is meant to make the network function as a unified program, improve consistency and quality across sites, accelerate trial execution and enrollment, strengthen biomarker and immune-monitoring science, and ensure that agents, specimens, and datasets are managed and shared in ways that maximize scientific impact.

• The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Coordinating Center for Canine Immunotherapy Trials and Correlative Studies (U24)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.394, 93.395, 93.396, 93.399.
• This funding opportunity was created on Dec 16, 2016.
• Applicants must submit their applications by Mar 07, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $350,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

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