Notice of Intent to Publish a Request for Applications for a Cancer Immunotherapy Trials Network (U01)

Notice Number: NOT-CA-09-016

Key Dates
Release Date: April 9, 2009

Issued by
National Cancer Institute (NCI), (


The Notice is to announce that the National Cancer Institute (NCI) intends to publish a new Request for Applications (RFA) for a “Cancer Immunotherapy Trials Network (CITN)”. The CITN initiative is being developed to address an important need in the cancer treatment arsenal for an organized, multi-site approach to bringing forward early phase trials in cancer immunotherapy. 

The CITN program is expected to foster multi-institutional and transdisciplinary interactions with the goal to provide a new route for completion of multi-site Phase I and early Phase II trials. The CITN is intended for clinical trials that will:

(a) focus on high priority biologic agents;
(b) include patient outcome-associated biomarkers; and
(c) use standardized specimen collection and immunomonitoring.

The CITN RFA will utilize the NIH cooperative agreement U01 mechanism. The NCI Board of Scientific Advisors has approved the concept of this RFA and associated set-aside funds ($1,600,000 in Fiscal Year 2010) for one multi-institutional CITN award under this program.

This Notice is being provided to allow potential applicants sufficient time to develop required collaborations and meaningful projects that would be responsive to the outlined requirements. Applications are NOT being solicited at this time.

The CITN RFA is expected to be published by July, 2009 with the application receipt date in the fall of 2009. 

Background and Details of the CITN Initiative

An increased understanding of the science of tumor immunology in the past decade has resulted in a new awareness of the complexities of tumor-host interactions in the tumor microenvironment, with new methods available to overcome immune tolerance and immune suppression.  These advances provide impetus for new clinical trials aimed at shifting the balance of positive and negative signals toward clinically effective ant-tumor responses. Such clinical trials will likely require a mix of therapeutic approaches, combinations of carefully prioritized agents, and manipulation of the tumor microenvironment. In this context, a number of immunotherapeutic agents (including antibodies, cytokines, and immune adjuvants) were identified as “high priority” for clinical development at the 2007 NCI Immunotherapy Agent Workshop. The CITN initiative will support a multi-investigator/multi-site team as a new collaborative pathway for bringing these prioritized agents to the clinic.

Interested investigators with expertise in immunotherapy trials are encouraged to consider proactively the formation of appropriate collaborations that will be needed for applying for the CITN RFA.  Specifically, the CITN is intended to bring together clinical immunotherapy treatment sites with documented experience in participating in Phase I and II immunotherapy clinical trials. The network will be limited to 6-8 such institutions, although ancillary clinical sites will be permitted to join specific clinical trials. The CITN will also be composed of select tumor immunology laboratories, either academic, government, or commercial, which are envisioned to provide high quality tumor immunology expertise to complete standardized immune assessment assays, biomarker studies linked to patient outcome, and/or correlative science studies to inform future trials.

The CITN program will receive additional support from the NCI. Specifically, in order to move rapidly into clinical trials, the CITN will be served by the NCI’s Cancer Trials Support Unit (CTSU) as the data management and patient enrollment center. This center will be funded outside the expected U01 award for the initial two years.  Moreover, the NCI intramural program is expected to provide additional clinical and/or laboratory sites for certain CITN clinical trials.  


Interested parties may contact:

William D. Merritt, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, Suite 7009
Rockville, MD 20852
Telephone: (301) 496-8866
FAX: (301) 480-4663


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