Cancer Immunotherapy Trials Network (U01)

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Purpose. The purpose of this funding opportunity announcement (FOA) is to stimulate the conduct of early (Phase I and Phase II) clinical trials in the area of cancer immunotherapy by forming a Cancer Immunotherapy Trials Network (CITN). The emphasis is on clinical trials of high priority agents that were identified at the 2007 NCI immunotherapy agent workshop and on clinical trials using combinations of immunotherapy modalities and other agents. The CITN will support a multi-investigator team assembled to bring new immunotherapy agents to the clinic. This support will be realized through a single award for a Central Operations and Statistical Center (COSC) of the CITN. Whereas this FOA solicits applications specifically for the CITN COSC, the awardee team and their Program Directors/Principal Investigators (PDs/PIs) will provide overall leadership and statistical and protocol coordinator support for the CITN program. COSC applicants must plan that the CITN will include the following additional elements : (1) up to 25 institutions that will conduct the clinical trials as CITN Member Sites (supported through subcontracts within the COSC award); (2) support for tumor immunology laboratories that are associated with the Member Sites to conduct standardized immunomonitoring assays and biomarker and correlative studies related to the clinical trials; and (3) a data coordinating service that will be provided by a unit operated by the NCI (which remains beyond the scope of solicited applications).

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