DOD Kidney Cancer, Clinical Trial Award | W81XWH 21 KCRP CTA

Opportunity Information: Apply for W81XWH 21 KCRP CTA

The DOD Kidney Cancer Research Program (KCRP) Clinical Trial Award is a Department of Defense funding opportunity meant to speed the launch of early-phase kidney cancer clinical trials, specifically phase 0, phase 1, and phase 1/2 studies. The main goal is to move promising ideas into human testing quickly, in a way that can meaningfully shift how kidney cancer is treated or managed. Projects can test a wide range of interventions, including drugs and biologics, medical devices, surgical approaches, behavior change strategies, clinical guidance, and newer technologies or emerging approaches. The program is also open to repurposing, meaning it encourages studies that take an existing intervention and test it for a new kidney-cancer-related use. The expectation is that results from these smaller, early trials will build a strong scientific case for later, larger trials focused on efficacy and eventual changes to standard patient care.

A core point of this award is that the funded work must be a clinical trial as defined by federal standards: human subjects must be prospectively assigned to one or more interventions (which can include placebo or control) to measure effects on biomedical or behavioral health outcomes. This mechanism is not meant for preclinical research; investigators proposing lab-only or animal-only work are directed to other KCRP announcements instead. Because this is human research, applicants are expected to follow a detailed set of clinical and regulatory expectations, and the opportunity points applicants to a DoD Human Subjects Resource Document for additional guidance.

Regulatory readiness is a major theme. If the trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) application may be required under 21 CFR 312. If an IND is required, it must be submitted to the FDA by the application submission deadline, and it must match the specific product and the specific indication being tested (not a related derivative or alternate version). If the intervention is a device, an Investigational Device Exemption (IDE) may be required under 21 CFR 812, with similar expectations that the IDE be submitted by the deadline when required and that it align with the exact device and indication in the proposed study. If the project includes international clinical sites, the applicant must also show that submissions to the relevant national regulatory authorities in the host country or countries have been made by the deadline. When an IND or IDE is not required, the applicant must provide documentation from the IRB of record or the FDA supporting that determination.

The program lays out practical start-up and execution requirements intended to ensure the study can actually run. Trials are expected to begin within 12 months of the award date, so proposals need to show they are ready to move. Preliminary data relevant to the clinical trial is required, and the trial must be grounded in a clear scientific rationale supported by critical review of the literature. Applicants are expected to define clear objectives and appropriate endpoints, and to design the study in line with Good Clinical Practice (GCP). A strong statistical plan is required, including power and sample size justification and access to appropriate statistical expertise. On the operational side, proposals must include a data management plan, use an appropriate database, and, if FDA-regulated, use systems compliant with 21 CFR Part 11 along with appropriate data standards. Safety oversight also needs to be spelled out through a safety management and pharmacovigilance plan when applicable, plus a clinical monitoring plan describing how compliance and data integrity will be monitored across the study.

Feasibility and access are treated as make-or-break issues. Applicants must demonstrate access to a suitable patient population and provide a realistic accrual plan that explains how enrollment targets will be met, including how existing standards of care might affect recruitment or eligibility. The application must also document availability of the intervention and any needed materials for the full duration of the study, with product quality and stability documented at a level consistent with FDA expectations for the intervention type and trial phase (for example, GMP-related expectations). Importantly, the announcement specifies that award funds cannot be used to cover costs of producing or acquiring the intervention itself, such as purchasing it from a manufacturer, so applicants need to have a separate, documented path to secure the product. The program also looks for evidence that the team can work effectively with regulators, including prior FDA interaction and submissions when relevant. Staffing expectations include having study coordinator support to navigate IRB and other regulatory approvals, coordinate multi-site activities, and manage accrual efforts.

The award also emphasizes what happens after the trial. Applications must include a Transition Plan that explains how the product or approach will move to the next phase of clinical testing and/or toward market delivery if the early trial is successful, including potential funding sources and resources to support that next step. Institutional support must be clear, and if the project requires an FDA regulatory sponsor, the application should show commitment and capability to fulfill sponsor responsibilities described in 21 CFR 312 Subpart D. For transparency and public accountability, funded trials must register on ClinicalTrials.gov before the study begins, and they are required to post the informed consent form on a publicly available federal website in line with federal requirements (32 CFR 219).

From an administrative and funding standpoint, awards are issued as assistance agreements, which can be either grants or cooperative agreements. Whether it becomes a grant or a cooperative agreement depends on how much substantial involvement the DoD anticipates having during the project, with cooperative agreements used when the agency expects to collaborate, participate, or intervene in aspects of the research. The opportunity is run by the Department of Defense (Department of the Army, USAMRAA) under CFDA 12.420, and eligibility is broadly open (unrestricted) unless otherwise limited by the full announcement.

In terms of scale, the anticipated direct cost cap for the full period of performance is up to $2.0 million per award. The program expected to allocate about $12.8 million total to fund roughly four awards under this announcement. Awards were planned to be made by September 30, 2022, and the funding is tied to FY21 appropriations with an expiration for use on September 30, 2027. The research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public, and the program strongly encourages collaborations between military or VA institutions and civilian organizations to combine expertise, infrastructure, and access to patient populations. The announcement also flags alignment with recommendations from the Congressionally mandated Metastatic Cancer Task Force, encouraging applicants to consider those priorities when proposing kidney cancer trials that fit within the scope of the mechanism.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Kidney Cancer, Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Jun 14, 2021.
• Applicants must submit their applications by Oct 05, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 4 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

Apply for W81XWH 21 KCRP CTA

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