This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Peer Reviewed Cancer Research Program

Clinical Trial Award

Funding Opportunity Number: HT942526PRCRPCTA

Pre-Application Due: June 26, 2026

Application Due: October 5, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Peer Reviewed Cancer Clinical Trial Award 2

Content

Before You Begin 3

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Clinical Trial Award; provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes for application compliance review, pre-application and full application selection/notification, and risk assessment. Also, details the review criteria for pre-application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

FY26 Peer Reviewed Cancer Clinical Trial Award 3

Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:~:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:~:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:~:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Peer Reviewed Cancer Clinical Trial Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Peer Reviewed Cancer Research Program (PRCRP) Clinical Trial Award (CTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of cancer within at least one of the FY26 PRCRP Topic Areas. Clinical trials proposed may evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) that evaluate the effects of interventions or inform the design of more advanced trials to large-scale trials (up to phase III) to determine efficacy in relevant patient populations.

Distinctive Features:

• Applications to this award mechanism must include a clinical trial.

• Projects can range from phase 0 to phase III.

• If an Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or equivalent, is required, a regulatory application must be submitted to the relevant regulatory agency by the Clinical Trial Award application submission deadline. The regulatory application should be specific to the product and indication to be tested in the proposed clinical trial.

• Applications are required to include patient advocates.

• Animal studies are NOT allowed under this award mechanism. All preclinical work must be completed prior to the award start date.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $45.0M to fund approximately 10 Clinical Trial Award applications with total cost caps of $4.5M per award. The maximum period of performance is 4 years. It is anticipated that awards made from this fiscal year 2026 (FY26) funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), June 26, 2026

• Invitation to Submit an Application: August 10, 2026

• Application Submission Deadline: 11:59 p.m. ET, October 5, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 8, 2026

• Peer Review: December 2026

• Programmatic Review: February 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526PRCRPCTA

Assistance Listing Number: 12.420

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FY26 Peer Reviewed Cancer Clinical Trial Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Independent investigators at all career levels affiliated with an eligible organization are eligible to be named as Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%201.%0ARECIPIENT%20QUALIFICATION%20AND%20RESTRICTION%20INFORMATION

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Peer Reviewed Cancer Clinical Trial Award 6

3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Peer Reviewed Cancer Research Program (PRCRP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the PRCRP in 2009 to provide support for research of high potential impact and exceptional scientific merit. Appropriations for the PRCRP from FY09 through FY25 totaled $1.17 billion. The FY26 appropriation is $165 million (M).

Congressional language stipulates the FY26 PRCRP must be relevant to Service Members, and address at least one of the congressionally directed FY26 PRCRP Topic Areas listed below.

• Bladder cancer

• Blood cancers

• Brain cancer

• Colorectal cancer

• Endometrial cancer

• Esophageal cancer

• Germ cell cancers

• Glioblastoma

• Liver cancer

• Lymphoma

• Mesothelioma

• Metastatic cancers

• Myeloma

• Neuroblastoma

• Neuroendocrine Tumors

• Pediatric, adolescent, and young adult cancers1

• Pediatric brain tumors

• Sarcoma

• Stomach cancer

• Thyroid cancer

Research proposed to the PRCRP must not address research in melanoma, or cancers originating in the breast, kidney, lung, pancreas, prostate or ovary. In addition, FY26 PRCRP funds must not be used to study rare cancers except FY26 PRCRP Topic Area cancer types that are rare by definition.

FY26 PRCRP Portfolios and Strategic Goals

To meet the intent of the funding opportunity, all applications for FY26 PRCRP funding must specifically address one of the FY26 PRCRP Topic Areas as directed by the U.S.

Congress and have direct relevance to military health. Additionally, the PRCRP implements a portfolio-driven approach by grouping related topic areas with strategic goals as a framework within which to address critical gaps in cancer research and patient care. All applications must address one of the FY26 PRCRP strategic goals as it relates to the portfolio-assigned FY26 PRCRP Topic Area. Some topic areas are present in more than one portfolio.

Applications must align to the strategic goal of the portfolio in which a topic area is included. If the proposed research does not specifically address one FY26 PRCRP Topic Area and one FY26 PRCRP strategic goal from a single portfolio, then the government reserves the right to administratively withdraw the application. The government reserves the right to reassign

1 The definition of adolescents and young adults is derived from the National Cancer Institute (https://www.cancer.gov/types/aya). Research should be targeted toward pediatric (ages 0-14 years), adolescents (ages 15-24 years), and/or young adults (ages 25-39 years).

https://www.cancer.gov/types/aya

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FY26 Peer Reviewed Cancer Clinical Trial Award 7 the application’s topic area if submitted to an incorrect topic area. The table below lists the FY26 PRCRP Topic Areas and strategic goals in each PRCRP portfolio category.

Portfolio: Blood Cancers

All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: Blood cancers, Lymphoma, Myeloma

Knowledge Areas:

Strategic Goals:

Prevention and Etiology

• Improve risk assessment of precancerous conditions

• Develop early intervention strategies to prevent initiation and/or progression

• Investigate autoimmune disorders as risk factors for lymphoma to inform surveillance strategies

• Understand the role of cancer stem cells and the tumor microenvironment in the development of blood cancers

Diagnosis and Prognosis

• Improve methods for early detection, prognostic evaluation and/or therapeutic stratification

• Develop more cost-effective molecular diagnostics

• Identify biomarkers to predict progression from indolent disease

• Identify unique prognostic factors in pediatric, adolescent and young adult malignancies

Treatment • Develop new, less toxic therapies

• Develop methods to predict therapeutic vulnerabilities

• Develop therapies that don’t require hospitalization

• Develop therapies employing gene editing technologies and cell therapies

• Identify contribution of immune niche to initial treatment response and relapse

• Develop therapeutic options for patients who fail last line therapies

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

• Identify long-term effects of gene editing and cell therapies and develop risk-based standards for surveillance of treated patients

• Improve understanding of the effects of long-term immunosuppression

Epidemiology • Design population-based studies to identify and characterize risk factors related to malignancy

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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FY26 Peer Reviewed Cancer Clinical Trial Award 8

Portfolio: Gastroenterological Cancers

All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: Colorectal cancer, Esophageal cancer, Liver cancer, Stomach cancer

Knowledge Areas:

Strategic Goals:

Prevention and Etiology

• Identify modifiable and non-modifiable risk factors to inform prevention strategies

• Identify factors driving the increasing rates of early-age onset disease

• Identify environmental and genetic factors associated with an increased cancer risk

• Identify key drivers of conversion from precancerous lesions into cancer

• Explore the interplay between the microbiome and infectious agents in cancer initiation and progression

• Conduct integrative studies that analyze stool, blood and the microbiome as they impact disease onset and patient outcomes

Diagnosis and Prognosis

• Improve methods for early detection, prognostic evaluation and/or therapeutic stratification

• Develop cost-effective and minimally invasive tools for early detection

• Develop preclinical models to study disease development

Treatment • Develop new, less toxic therapies

• Develop effective treatments for advanced disease

• Develop immunotherapies and novel targeting therapies

• Identify combination therapies to improve patient outcomes

• Identify predictive biomarkers to determine treatment response

• Develop integrated treatment plans to address short and long-term impacts of cancer

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

• Improve post treatment surveillance guidelines

• Develop validated tools to measure patient quality of life

Epidemiology • Design population-based studies to identify and characterize risk factors related to malignancy

• Implement systems to analyze disease patterns and track patient outcomes to inform best practices

• Examine the influence of familial genetics and geographic location on disease onset and treatment outcome

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Peer Reviewed Cancer Clinical Trial Award 9

Portfolio: Neurological Cancers

All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: Brain cancer, Glioblastoma, Pediatric Brain Tumors

Knowledge Areas:

Strategic Goals:

Prevention and Etiology

• Identify biological and environmental exposures, including maternal exposures during pregnancy, that increase risk

Diagnosis and Prognosis

• Develop early detection methods that avoid diagnostic uncertainties

• Develop effective monitoring for recurrence/refractory disease

• Develop less invasive diagnostic procedures

Treatment • Develop new, less toxic therapies

• Prevent or overcome treatment resistance

• Develop personalized oncological care and synergistic multi-modal therapies

• Identify protective therapies to be used in conjunction with toxic therapies to reduce treatment-related damage

• Develop less invasive treatment options

• Develop therapies that cross the blood-brain-barrier

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

• Develop effective screening, monitoring, and provision of psychosocial support/care for the patient and family

• Develop care for patients as they transition from pediatric to adult survivors

Epidemiology • Analyze and assess the incidence/prevalence of brain tumors over time to identify changes in trends

Technology Development

• Advance the development or adoption of technologies in areas including artificial intelligence and machine learning, human microbiota, genomics, nanoparticles and robotics

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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FY26 Peer Reviewed Cancer Clinical Trial Award 10

Portfolio: Pediatric Adolescent and Young Adult Cancers (PAYAC)

All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: PAYAC, Germ cell cancers, Neuroblastoma, Sarcoma, Thyroid cancer

Knowledge Areas:

Strategic Goals:

Prevention and Etiology

• Determine the molecular basis of cancer predisposition syndromes

• Determine the extent to which development of disease is attributable to genetic versus environmental differences

• Increase understanding of epigenetic influences on cancer development and progression

• Identify biological and environmental exposures, including maternal exposures during pregnancy, that increase risk

• Investigate the role of microbiome composition in cancer risk and outcomes

Diagnosis and Prognosis

• Improve methods for early detection, prognostic evaluation and/or therapeutic stratification

• Develop noninvasive techniques for monitoring progression and recurrence

• Identify biomarkers present in early-stage disease

• Develop preclinical models that accurately mimic disease

• Improve accurate and rapid diagnosis of sub-types of disease

Treatment • Develop new, less toxic therapies

• Develop treatments for relapse/recurrence, metastatic and advanced disease

• Increase the number of clinical trials, including ones that may not be curative but may improve the quality of life for terminal patients

• Generate evidence-based treatment and surveillance strategies to preserve fertility

• Reduce secondary cancers arising from treatment regimen

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

• Develop strategies to improve the full implementation of survivorship guidelines

• Develop survivorship guidelines based on current/modern therapeutic agents

Epidemiology • Design population-based studies to identify and characterize risk factors related to malignancy

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Peer Reviewed Cancer Clinical Trial Award 11

Portfolio: Solid Tumors

All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: Bladder cancer, Endometrial cancer, Mesothelioma, Sarcoma, Germ cell cancers, Thyroid cancer, Neuroendocrine tumors

Knowledge Areas:

Strategic Goals:

Prevention and Etiology

• Develop methods that mitigate or identify risk

• Develop prevention strategies

• Explore the mechanistic relationship between novel and known risk factors and oncogenesis

• Identify convergent etiologies underlining the development of malignancies

Diagnosis and Prognosis

• Improve methods for early detection, prognostic evaluation and/or therapeutic stratification

• Investigate the interactions of pre-existing autoimmune disease and cancer

Treatment • Develop new, less toxic therapies

• Develop feasible precision medicine approaches

• Identify ways to tailor therapeutic strategies to minimize toxicity

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

Epidemiology • Design population-based studies to identify and characterize risk factors related to malignancy

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Peer Reviewed Cancer Clinical Trial Award 12

Portfolio: Metastatic Disease

All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Area: Metastatic Cancers, limited to PRCRP topic area cancers

Knowledge Areas:

Strategic Goals:

Prevention and Etiology

• Identify biomarkers in primary disease that could predict metastatic potential

• Prevent immune evasion by circulating tumor cells

• Identify how dormant, disseminated tumor cells (DTCs) persist

• Identify drivers that initiate DTCs progression to metastatic colonies

• Prevent metastatic colonization by maintaining dormancy of DTCs

• Investigate clonal divergence of primary tumor cells between metastatic sites to immunological disease

Diagnosis and Prognosis

• Improve early detection of metastasis and dormant residual disease

• Develop biomarkers that predict and monitor treatment efficacy

Treatment • Develop new, less toxic therapies

• Revert metastatic cells to a dormant state

• Identify strategies to prevent or overcome treatment resistance

• Investigate abscopal effects of primary disease treatment

• Determine optimal sequencing of treatments

• Eliminate chemotherapy-induced metastasis

Survivorship • Develop strategies to alleviate treatment toxicities

• Improve quality of life for survivors and/or caregivers

Metastatic cancer is cancer that has spread from its original location to another place in the body, representing what are known as stage III and stage IV cancer diagnoses. While recent research has revealed that there is a genetic basis for susceptibility or resistance to metastasis, more research is needed to develop a comprehensive understanding of this complex process.

Applications submitted under any PRCRP topic area, including the Metastatic cancers topic area, may not address or include research focused on melanoma or cancers that originate in the breast, kidney, lung, pancreas, prostate, or ovaries, or rare cancers (excluding relevant subtypes of the FY26 PRCRP Topic Areas) as part of the research study; such applications will be administratively withdrawn.

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FY26 Peer Reviewed Cancer Clinical Trial Award 13

FY26 PRCRP Military Health Focus Areas

It is central to the Vision and Mission of the PRCRP that applications are related to military health and mission readiness, and investigators must demonstrate how the proposed research will decrease the burden of cancer on Service Members, their dependents, Veterans and other military beneficiaries (i.e., Retirees and their Family members).

In addition to addressing at least one of the required FY26 PRCRP Topic Areas and FY26 Strategic Goals, applications for the FY26 Clinical Trial Award must define how the research is relevant to Service Members and their Families by addressing at least one of the FY26 PRCRP Military Health Focus Areas listed below.

FY26 PRCRP Military Health Focus Areas:

• Environmental exposure risk factors associated with cancer

○ Environmental and/or occupational risk factors should be relevant to activities specific to the military, such as assigned duties or deployments that may lead to exposures to potential carcinogens (ionizing radiation, chemicals, infectious agents, etc.). For more information on military-related exposures and risk factors for cancer, applicants should refer to Exposure-Related Health Concerns at https://www.publichealth.va.gov/exposures/health-concerns.asp or to the PRCRP website (https://cdmrp.health.mil/prcrp/default).

• Mission Readiness and Gaps in Cancer Research

○ Gaps in cancer prevention, early detection/diagnosis, prognosis, and/or treatment that may impact mission readiness and the health and well-being of military members, Veterans, their beneficiaries and the general public.

○ Gaps in quality of life and/or survivorship that may impact mission readiness and the health and well-being of military members, Veterans, their beneficiaries and the general public.

Mission readiness under the FY26 PRCRP Military Health Focus Areas refers to the impact of cancer on the Service Member. Decreasing the impact of cancer on Service Members and/or their Families protects the overall military missions. Some examples of relevant research to decrease the impact on mission readiness may include, but are not limited to:

• Studies on the improvement in survival while minimizing effects that would allow an active-duty Service Member to return to full duty;

• Treatments to minimize a cancer patient’s (either a Service Member’s or their Family member’s) time in the hospital, thus maximizing the time the Service Member is on duty;

• Effective ways to minimize cancer relapse for Service Members or their Families; and

• Research into improvements in cancer detection that would lead to earlier diagnosis, thus allowing for improved treatment of the Service Member and early return to duty.

For more information on military health and cancer:

• PRCRP (https://cdmrp.health.mil/prcrp/default)

• Military Health System (MHS) (https://www.health.mil)

• U.S. Department of Veterans Affairs (VA) (https://www.va.gov/) https://www.publichealth.va.gov/exposures/health-concerns.asp https://cdmrp.health.mil/prcrp/default https://cdmrp.health.mil/prcrp/default https://www.health.mil/ https://www.va.gov/

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Peer Reviewed Cancer Clinical Trial Award 14

The PRCRP strongly encourages investigators to collaborate, integrate, and/or align their research projects with DOW and/or VA research laboratories and programs (Refer to GSI Appendix 10).

3.1. Intent of the Clinical Trial Award

The FY26 PRCRP Clinical Trial Award (CTA) mechanism supports the rapid execution and analysis of clinical trials with the potential to have a significant impact on the treatment or management of cancer within at least one of the FY26 PRCRP Topic Areas. Investigators may design a clinical trial to evaluate promising new products, pharmacologic agents (drugs, biologics or medical devices), clinical guidance and/or emerging approaches and technologies.

Proposed projects may range from small proof-of-concept trials (i.e., pilot, first-in-human, phase

0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations. The proposed clinical trial must begin no later than 12 months after the award date or 18 months after the award date for studies regulated by the Regulatory Agency.

Funding from this award mechanism must support a clinical trial.

3.1.1. Key Elements for the CTA

• Impact: The proposed intervention(s) should offer significant potential for advancing to the next stage of clinical study, transition of results to fielded science, or improve the standard of care for at least one of the FY26 PRCRP Topic Areas and address one of the FY26 PRCRP Military Health Focus Areas and one of the FY26 PRCRP Strategic Goals. The impact of the intervention should include considerations of quality of life and supportive care during the trial.

• Applications require supportive preclinical data: Applications must include supportive preclinical data relevant for the clinical trial. No proposed preclinical research to support an IND/IDE application is allowed. No animal work is allowed.

• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how the research team will achieve accrual goals.

as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, sex, ethnicity or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

• Intervention Availability: The application should demonstrate the documented availability of and access to the drug/compound, device and/or other materials needed, as appropriate, for the proposed duration of the study.

• Research Personnel and Environment: The application should demonstrate the study team’s expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of U.S. Food and Drug Administration (FDA) processes (if applicable), and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local IRB of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=agreement%20is%20issued.-,APPENDIX%2010.,-DOW%20AND%20VA

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FY26 Peer Reviewed Cancer Clinical Trial Award 15 sponsor, ensuring all sponsor responsibilities described in Code of Federal Regulations, Title 21, Part 312, Subpart D (21 CFR 312, Subpart D), are fulfilled.

• Patient Advocates: Applications are required to include patient advocate involvement. The research team must include two or more patient advocates who will be integral throughout the planning and implementation of the research project. Patient advocates should be involved in the development of research questions, project design, oversight, recruitment and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. As lay representatives the patient advocates must be individuals who have been directly impacted by cancer either by being diagnosed themselves or as a caretaker/family member of a patient. Their role in the project should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with or at risk of cancer. The patient advocates should have a high level of knowledge of current cancer issues and the appropriate background and/or training in cancer research to contribute to the project.

When developing applications to the PRCRP CTA mechanism, the PRCRP strongly encourages applicants to provide sufficient evidence to demonstrate the following key considerations:

• Availability of, and access to, the study population.

• Intervention access and availability.

• Appropriate study team composition.

• Statistical considerations, data management and analysis plans appropriate for the proposed research.

3.1.2. Other Important Considerations for the CTA

Funding from this award mechanism must support a clinical trial. Preclinical research is not supported in this funding opportunity.

Applicants seeking funding for research that does not meet the definition of a clinical trial should consider other FY26 PRCRP funding opportunities that may be more appropriate for such research.

An informational resource for preparing an application, the Human Subject Research Resource, is available on the CDMRP website.

The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for studies regulated by the Regulatory Agency. Unless otherwise noted, for the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any equivalent international regulatory agency.

If an IND application, IDE, or equivalent, is required, a regulatory application must be submitted to the relevant regulatory agency by the Clinical Trial Award application submission deadline. The regulatory application should be specific to the product and indication to be tested in the proposed clinical trial (this includes clinical trials requesting exception from informed consent under 21 CFR 50.24.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://cdmrp.health.mil/#:~:text=Human%20Subject%20Research%20Resource https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines

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FY26 Peer Reviewed Cancer Clinical Trial Award 16

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the VA and other federal government agencies are highly encouraged. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY26 PRCRP priorities.

3.2. Funding Instrument

The funding instrument for awards made under the program announcement will be grants

(31 USC 6304).

3.3. Funding Details

Period of Performance: The maximum period of performance is 4 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $4.5M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

Research milestones to be accomplished by the end of each year in the period of performance must be clearly defined in the project SOW and will be finalized during award negotiations. The PI(s) will be required to present an update on progress toward accomplishing research milestones and goals of the project at an annual Milestone Meeting to be held virtually at the discretion of the government. Annual Milestone Meetings will be held at the conclusion of year 1 and may be held every subsequent year in the period of performance. Milestone Meetings will be attended by members of the PRCRP Programmatic Panel, CDMRP staff and the DHACA Grants Officer.

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES:~:text=agreement%20is%20issued.-,APPENDIX%2010,-.%0ADOW%20AND https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost

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• Research subject compensation and reimbursement for trial-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving and resources/equipment to enable participation).

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to one scientific/technical meeting per year in addition to the required meeting described above. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the PRCRP

CTA.

Must not be requested for:

• Costs for travel to scientific/technical meeting(s) beyond the limits stated above.

• Preclinical research costs.

• Tuition.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

Pre-application submissions must include the following components.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (three-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ Background: State the FY26 PRCRP Topic Area(s) and FY26 PRCRP Strategic Goal the application will address.

○ Research Idea and Impact: Describe how the proposed research will have a significant impact on the treatment or management of cancer within at least one of the FY26 PRCRP Topic Areas. Describe the ideas and scientific rationale on which the proposed clinical trial is based; include relevant literature citations. State the clinical intervention, subject population(s), phase of the clinical trial proposed, regulatory status and sponsor.

○ Project Readiness: Briefly describe the project readiness to include the level of scientific evidence that supports the initiation of the proposed clinical trial, and the availability of, and accessibility to, the intervention and the proposed subject population.

Describe a plan to submit an IND/IDE by the full application deadline or describe why the proposed research does not need one.

○ Clinical Strategy: Concisely state the project’s hypothesis and/or objectives. Briefly describe the clinical approach, including study design, endpoints/outcome measures and statistical methods for analysis.

○ Personnel: Briefly state the qualifications of the PI and key personnel to perform the clinical trial. Note any DOW- or VA-relevant collaborations.

○ Military Relevance: Explain how the proposed research will lead to promising outcomes for one or more of the selected FY26 PRCRP Military Health Focus Area(s).

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

○ List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols used in the Preproposal Narrative.

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications, and previous work accomplished.

○ Letters of Support (if applicable): Letters of support should be provided to demonstrate commitment of collaborators (i.e., industry partners) to proposed study.

4.3. Full Application Components

Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected.

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (20-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below. It should be evident that the proposed study meets the definition of a clinical trial.

– Background: Describe in detail the scientific rationale for the study. Provide a review and analysis of the available literature and completed/ongoing studies relevant to the proposed clinical trial.

▪ Describe the preliminary studies and/or preclinical data that support the proposed clinical trial.

▪ Summarize key preclinical pharmacological findings, dosage studies and other clinical studies (if applicable) that examine the safety and stability (as appropriate) of the intervention.

▪ Provide a summary of other relevant ongoing, planned or completed clinical trials, and describe how the proposed study differs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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▪ Describe how the proposed project addresses a FY26 topic area and corresponding FY26 PRCRP Strategic Goal.

If the proposed clinical trial was initiated using other funding prior to this application, explain the history and background of the clinical trial and declare the source(s) of prior funding. Identify the specific portions of the study that will be supported with funds from this award.

– Intervention: Identify the intervention to be tested. Include the following components, as applicable: intervention type (drug, device, behavioral, surgical, etc.), complete name and composition, source, general concept of design, administration route. Indicate who holds the intellectual property rights to the intervention, if applicable, and how the PI has obtained access to those rights, along with access to the intervention itself, for conduct of the clinical trial. As applicable, appropriate letters of commitment should be provided in Attachment 2: Supporting Documentation, demonstrating the study team’s access to the intervention(s) for the duration of the clinical trial. Describe how the intervention addresses current clinical needs and how it compares with currently available interventions and/or standards of care.

– Objectives, Specific Aims and Hypotheses: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested in the proposed clinical trial and detail the specific aims that will address the hypothesis/research question.

– Study Design: Describe the proposed clinical trial in sufficient detail to evaluate its appropriateness and feasibility, relating to both the scientific success of the study and setting reasonable expectations of what study participants will experience.

Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ Describe the type of study to be performed. Outline the proposed clinical trial methodology and study variables in sufficient detail to demonstrate a clear course of action and justification. Describe the interaction with the human subject, including the study intervention that they will experience, and include the dose and administration route.