DoD Kidney Cancer, Clinical Trial Award | W81XWH 22 KCRP CTA

Opportunity Information: Apply for W81XWH 22 KCRP CTA

The Department of Defense (DoD), through the Congressionally Directed Medical Research Programs (CDMRP) Kidney Cancer Research Program (KCRP), offered the Clinical Trial Award (W81XWH-22-KCRP-CTA) to speed the launch of early-phase kidney cancer clinical trials that could meaningfully change how kidney cancer is treated or managed. The program is specifically aimed at phase 0, phase 1, and phase 1/2 studies that generate credible, actionable signals and the scientific justification needed to move into larger, efficacy-focused trials later. In practical terms, the award is meant to push promising approaches into the clinic quickly, so the results can guide the next step of development rather than remaining stuck at the preclinical stage.

A central requirement is that the funded project must be a clinical trial as defined by prospective assignment of one or more human subjects to one or more interventions (including placebo or control, when appropriate) to measure biomedical or behavioral outcomes. This mechanism is not intended for preclinical work, and applicants proposing non-clinical studies are directed to other KCRP funding announcements. The announcement emphasizes flexibility in what counts as an intervention, allowing trials that test drugs or biologics, devices, surgical procedures, behavior change strategies, clinical guidance, and other emerging technologies. It also explicitly welcomes studies that repurpose existing interventions for new kidney cancer indications, which can be a faster path to patient impact when safety profiles and manufacturing pathways are already established.

Two options introduced as new features for FY22 broaden how teams can structure proposals. The Cell Therapy Focus Option allows support for cell therapy trials, recognizing that these studies often require extra resources for manufacturing optimization and intensive correlative science; under this option, applicants can request a higher funding cap within the allowed performance window, but they must show confirmed access to the needed specimens and/or cohort data at the time they apply. The Qualified Collaboration Option is designed to encourage investigators to plug into established, federally funded consortia or partnerships (for example, groups with multi-institutional trial infrastructure). The idea is to reduce duplication and improve efficiency by using shared capabilities like data management, database administration, statistics support, and tissue repositories. To use this option, the application must include a letter of collaboration describing the partner organization’s concrete commitments and shared services, and explaining how that collaboration adds value to the government.

Operationally, the DoD expects these trials to move quickly. The clinical trial should begin within 12 months of the award date, or within 18 months if the study is FDA-regulated, reflecting the additional lead time needed for regulatory readiness. Competitive applications must include preliminary data relevant to the proposed trial, along with a clear demonstration that the investigators can actually recruit the participants they need. That means documenting access to an appropriate patient population, laying out realistic accrual goals and a recruitment plan, and addressing the inclusion of women and minorities in a way that fits the study’s objectives. The announcement also requires applicants to show documented access to the intervention (drug, device, or other materials) for the duration of the trial and to document product quality and stability in a manner consistent with applicable FDA manufacturing expectations (such as GMP or device Quality System standards). At the same time, there is a notable restriction: award funds generally cannot be used to pay for producing or purchasing the intervention itself from a manufacturer, so teams need a credible plan for obtaining the investigational product outside the grant budget.

The funding opportunity places heavy emphasis on execution capacity. Applications are expected to demonstrate that the team has real clinical trial expertise, including biostatistics, data management, and familiarity with FDA processes when relevant. The DoD also expects a study coordinator function capable of driving the protocol through IRB review and other regulatory approvals, coordinating multi-site activity, and managing participant accrual. For trials involving FDA-regulated products, the application should reflect institutional commitment and, when applicable, a willingness and ability to act as the regulatory sponsor and meet sponsor obligations under federal regulations (for example, 21 CFR 312 for drugs/biologics). The statistical and data infrastructure expectations are explicit: proposals must include a solid statistical analysis plan, power analysis and sample size justification aligned to the study objectives, and a data management plan that protects data integrity. If the trial is FDA-regulated, the database must be compliant with 21 CFR Part 11 and use appropriate data standards consistent with FDA expectations.

Regulatory readiness is treated as a gating issue, not an afterthought. If a drug is not FDA-approved for the proposed investigational use, an IND may be required, and the applicant is responsible for either (1) providing proof that an IND is not required or (2) submitting the IND to FDA by the application deadline. Similar requirements apply to devices via the IDE pathway, including evidence if an IDE is not required or qualifies for an abbreviated process; if an IDE is required, it must also be submitted by the application deadline. For trials that will run at international sites, applicants must show that submissions to relevant national regulatory authorities have been made by the deadline as well. After award, additional compliance steps include registering the trial on ClinicalTrials.gov before initiating the study and posting the informed consent form on a publicly available federal website as required by federal human subjects rules.

Because this is DoD-funded human research, the Human Research Protection Office (HRPO) within USAMRDC must review and approve the study before it can begin, and that HRPO review is separate from local IRB or Ethics Committee review. Local IRB approval is not required at the time of application submission, but awardees should plan for the HRPO review timeline (often up to around three months once complete documentation is submitted). For multi-institutional trials in the United States, applications must describe the governance structure, include a plan for single-IRB arrangements, identify the lead institution responsible for the master protocol and consent, and address communication, data transfer, and handling of specimens and imaging products. Multi-site projects also require an intellectual and material property plan agreed to by all participating institutions. If the work relies on DoD or VA resources, databases, or access to active-duty populations, the application must describe how access is secured at submission and how it will be maintained during the project.

From a funding and award-structure standpoint, the mechanism uses assistance agreements, meaning awards may be issued as either grants or cooperative agreements depending on how much substantial involvement the DoD anticipates during performance. Budget limits are set in direct costs for the entire period of performance: up to $1.5 million for the standard Clinical Trial Award and the Qualified Collaboration Option, and up to $2.0 million for the Cell Therapy Focus Option. For this FY22 cycle, CDMRP planned to allocate about $8.0 million total to make roughly three awards (approximately two standard CTA awards and one Cell Therapy-focused award), contingent on federal funds and application quality. The posting lists an original closing date of October 20, 2022, with awards to be made no later than September 30, 2023, and notes that FY22 funds were expected to remain available for use only for a limited time window, expiring for use on September 30, 2028.

Overall, the opportunity is designed for teams that already have a credible intervention, preliminary supporting evidence, access to patients, and the operational and regulatory experience to launch an early-phase kidney cancer trial quickly. The DoD’s priorities show up in the insistence on start timelines, concrete recruitment feasibility, robust data and regulatory plans, and use of established infrastructure when possible, all with the end goal of generating results that can justify and shape larger confirmatory studies that improve kidney cancer care.

• 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 15, 2022.
• Applicants must submit their applications by Oct 20, 2022. (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 3 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.

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