Limited Competition: AIDS Malignancy Consortium (AMC; UM1 Clinical Trial Required) | RFA CA 24 028

Opportunity Information: Apply for RFA CA 24 028

The National Cancer Institute (NCI), through the National Institutes of Health (NIH), is offering a limited-competition cooperative agreement to support the AIDS Malignancy Consortium (AMC) under a UM1 mechanism that requires clinical trials. The AMC is described as a major, standing infrastructure rather than a single stand-alone study, built to drive coordinated, multi-site clinical research focused on cancers that occur in people with HIV. The overall purpose is to strengthen and accelerate cooperative efforts that move promising prevention and treatment strategies into well-designed clinical trials, while also using those trials as a platform to learn more about the underlying biology of HIV-associated malignancies.

The scientific scope centers on five linked goals. First, the consortium is expected to design, develop, and evaluate clinical interventions aimed at preventing and treating HIV-associated cancers. Second, it should advance more effective therapeutics and management strategies, which can include improving how existing therapies are used in people with HIV and testing new approaches tailored to this population. Third, AMC trials are intended to serve as an engine for biologic discovery, meaning the consortium should investigate cancer and virus biology in the context of clinical trials using correlative science and other embedded research activities. Fourth, the AMC must be able to address issues of international importance related to HIV-associated malignancies, reflecting the global relevance of HIV and cancer, even while applicant eligibility is primarily U.S.-based. Fifth, the consortium is expected to contribute to the broader research community by distributing excess tumor tissue and other relevant biologic fluids to the AIDS and Cancer Specimen Resource (ACSR), supporting ongoing and future investigations beyond the immediate AMC trial portfolio.

Structurally, the NOFO makes clear that the AMC must be organized into four core functional units that work together as an integrated network: a Coordination Center, Clinical Trial Sites, Network Laboratories, and a Statistical Center. The Coordination Center typically serves as the operational hub for protocol development, regulatory coordination, site management, communication, and overall trial execution across the network. Clinical Trial Sites provide the patient-facing capacity to enroll, treat, and follow participants under standardized protocols. The Statistical Center is responsible for trial design support, statistical analysis plans, data oversight, and rigorous interpretation of results to ensure the network produces credible, practice-relevant evidence. The Network Laboratories support both routine trial operations and the science that makes the trials informative, including specialized testing that may not be feasible at each clinical site.

A required element of the AMC organization is the presence of disease-oriented Working Groups focused on specific cancer categories in people with HIV. The NOFO specifies Working Groups for Kaposi Sarcoma, hematologic malignancies, human papillomavirus (HPV)-associated cancers, and solid tumors. These Working Groups are meant to concentrate expertise, identify the most pressing clinical questions, shape protocol concepts, and guide implementation in their respective disease areas. In practice, this arrangement is designed to ensure that the consortium maintains depth in each major cancer domain while still operating under a unified network structure.

The Network Laboratories have a particularly defined set of responsibilities. Beyond routine clinical trial support activities, they are expected to conduct pathogenesis-driven correlative studies, which are analyses tied directly to understanding mechanisms of disease and treatment response using samples and data collected during trials. They also must support clinical pharmacology and pharmacokinetics studies that evaluate interactions between anticancer agents and antiviral therapies, an area of special importance in HIV care where drug-drug interactions and overlapping toxicities can strongly influence safety and outcomes.

Equity and access are explicitly addressed through the requirement that all AMC clinical trials be available to participants of all racial and ethnic groups. This indicates an expectation that study design, site selection, recruitment approaches, and enrollment practices will support inclusive participation and that the evidence generated will be relevant across diverse populations affected by HIV-associated cancers.

From an administrative standpoint, this opportunity is a discretionary funding opportunity issued as a cooperative agreement, meaning NCI is expected to have substantial involvement in the conduct of the program compared with a standard research project grant. The funding opportunity title is "Limited Competition: AIDS Malignancy Consortium (AMC; UM1 Clinical Trial Required)," and the funding opportunity number is RFA-CA-24-028. It is tied to CFDA numbers 93.393, 93.394, 93.395, and 93.396, and the original closing date listed is January 10, 2025. The opportunity was created on August 13, 2024.

Eligibility is restricted in ways that matter for applicants with international footprints. Non-U.S. entities (foreign organizations) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. At the same time, the NOFO notes that foreign components, as defined in the NIH Grants Policy Statement, are allowed, which typically means certain discrete elements of the work can occur outside the U.S. when justified and compliant, even though the applicant organization itself must be eligible. The source data also lists small businesses among eligible applicants, though the practical fit depends on whether an applicant can credibly operate or lead the required consortium infrastructure and clinical trial network functions under the UM1 cooperative agreement model.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Limited Competition: AIDS Malignancy Consortium (AMC; UM1 Clinical Trial Required)" 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.
• This funding opportunity was created on 2024-08-13.
• Applicants must submit their applications by 2025-01-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA CA 24 028

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