Opportunity Information: Apply for RFA CA 10 007
Apply for RFA CA 10 007
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Cancer Immunotherapy Trials Network (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395 Cancer Treatment Research.
- This funding opportunity was created on Dec 1, 2009 and posted on Dec 1, 2009.
- Applicants must submit their applications by Feb 19, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
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Opportunity Summary:
The Cancer Immunotherapy Trials Network (CITN) (U01) funding opportunity, issued by the National Institutes of Health through the National Cancer Institute (NCI), was designed to speed up and strengthen early-stage cancer immunotherapy testing in humans by building a coordinated, multi-site clinical trials network. The main goal was to stimulate Phase I and Phase II immunotherapy trials, with a clear preference for testing high-priority immunotherapy agents highlighted during the 2007 NCI immunotherapy agent workshop, as well as trials that combine different immunotherapy approaches or pair immunotherapies with other types of anti-cancer agents. In practical terms, the FOA aimed to bring promising immune-based treatments into well-run, efficiently coordinated clinical studies so that safety, dosing, early signals of activity, and immune response effects could be evaluated in a consistent and credible way across multiple institutions.
A defining feature of this opportunity is that it did not fund a collection of independent trial sites through separate awards. Instead, it centered on a single cooperative agreement award to create and run the network's Central Operations and Statistical Center (COSC). The COSC was intended to function as the hub of the entire network: providing overall leadership, organizing and coordinating protocol development, managing study operations, and delivering the statistical expertise needed for designing trials, monitoring progress, and analyzing outcomes. The Program Directors/Principal Investigators (PDs/PIs) leading the COSC would effectively serve as the coordinating leadership team for the CITN program, ensuring that studies move from concept to activation to completion in a structured, network-wide manner.
Applicants for the COSC were required to plan for a broader network architecture beyond the central coordinating team. First, the CITN was expected to include up to 25 clinical institutions serving as Member Sites, where the actual Phase I and Phase II trials would be conducted. These Member Sites were to be supported through subcontracts issued under the COSC award, meaning the COSC awardee would not only coordinate scientific and operational work but would also manage a subcontracting structure to enable multi-institution participation. Second, the FOA emphasized the importance of standardized immunomonitoring and correlative science, requiring support for tumor immunology laboratories associated with the Member Sites. Those labs would carry out harmonized immune assays, biomarker testing, and other correlative studies tied to the clinical trials, helping the network learn not just whether an intervention works, but how it works immunologically and which patient or tumor characteristics might predict response. Third, the FOA noted that data coordinating services would be provided by an NCI-operated unit, and that this component was outside the scope of what applicants were being asked to propose; in other words, applicants were expected to integrate with an NCI-provided data coordinating resource rather than independently building that function.
From an administrative standpoint, this was a discretionary funding opportunity using the cooperative agreement mechanism (U01), which typically signals substantial scientific or programmatic involvement by the funding agency during the life of the award. The program fell under the health and education activity category and was associated with CFDA number 93.395 (Cancer Treatment Research). There was no cost sharing or matching requirement. Eligible applicants included a range of nonprofit and higher-education entities, including public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with 501(c)(3) status (other than institutions of higher education), and certain nonprofits without 501(c)(3) status (again, other than institutions of higher education).
Key dates show this was a time-limited call: it was posted and created on December 1, 2009, with an original and current closing date of February 19, 2010, and an archive date of March 22, 2010. The official FOA identifier was RFA-CA-10-007, titled "Cancer Immunotherapy Trials Network (U01)." For full details, the opportunity pointed applicants to the NIH grants guide posting, and provided NIH Office of Extramural Research webmaster contacts for technical access issues.
Frequently Asked Questions (FAQs)
What is the Cancer Immunotherapy Trials Network (CITN) (U01) funding opportunity?
The Cancer Immunotherapy Trials Network (CITN) (U01) was a National Institutes of Health (NIH) funding opportunity issued through the National Cancer Institute (NCI). It was designed to speed up and strengthen early-stage testing of cancer immunotherapies in humans by building a coordinated, multi-site clinical trials network focused on Phase I and Phase II studies.
What is the main purpose of this funding opportunity?
The primary purpose was to stimulate Phase I and Phase II immunotherapy trials and to move promising immune-based treatments into well-run, efficiently coordinated clinical studies. The intention was to evaluate safety, dosing, early signals of activity, and immune response effects in a consistent, credible way across multiple institutions.
What types of trials were emphasized?
The opportunity emphasized Phase I and Phase II immunotherapy trials, with a preference for trials testing high-priority immunotherapy agents highlighted at the 2007 NCI immunotherapy agent workshop. It also favored trials that combine different immunotherapy approaches or pair immunotherapies with other types of anti-cancer agents.
Did this opportunity fund multiple independent clinical trial sites through separate awards?
No. A defining feature was that it did not fund a collection of independent trial sites through separate awards. Instead, it centered on a single cooperative agreement award to create and operate the network's Central Operations and Statistical Center (COSC).
What is the Central Operations and Statistical Center (COSC)?
The COSC was intended to serve as the hub of the entire CITN. It would provide overall leadership, organize and coordinate protocol development, manage study operations, and deliver statistical expertise for trial design, monitoring, and analysis across the network.
What responsibilities were expected of the COSC leadership?
The Program Directors/Principal Investigators (PDs/PIs) leading the COSC were expected to function as the coordinating leadership team for the CITN program. They were responsible for ensuring studies moved from concept to activation to completion in a structured, network-wide manner.
How large was the expected network of clinical institutions?
The CITN was expected to include up to 25 clinical institutions serving as Member Sites where Phase I and Phase II trials would be conducted.
How were Member Sites intended to be supported financially?
Member Sites were to be supported through subcontracts issued under the COSC award. That means the COSC awardee was expected to manage a subcontracting structure to enable participation by multiple institutions.
What role did immunomonitoring and correlative science play in this opportunity?
The opportunity emphasized standardized immunomonitoring and correlative science. It required support for tumor immunology laboratories associated with Member Sites to conduct harmonized immune assays, biomarker testing, and other correlative studies linked to the clinical trials.
Why were tumor immunology laboratories and correlative studies important to the network?
These activities were intended to help the network learn not only whether an intervention works, but how it works immunologically and which patient or tumor characteristics might predict response.
Were applicants expected to build their own data coordinating center?
No. The funding opportunity stated that data coordinating services would be provided by an NCI-operated unit, and that this component was outside the scope of what applicants were being asked to propose. Applicants were expected to integrate with the NCI-provided data coordinating resource rather than independently building that function.
What funding mechanism was used for this program?
This was a discretionary funding opportunity using the cooperative agreement mechanism (U01), which generally indicates substantial scientific or programmatic involvement by the funding agency during the life of the award.
Which NIH institute issued this opportunity?
The opportunity was issued by the National Institutes of Health through the National Cancer Institute (NCI).
What was the official FOA identifier and title?
The official FOA identifier was RFA-CA-10-007, titled "Cancer Immunotherapy Trials Network (U01)."
What was the CFDA number associated with this funding opportunity?
The program was associated with CFDA number 93.395, Cancer Treatment Research.
What activity category was this program listed under?
The opportunity fell under the health and education activity category.
Was cost sharing or matching required?
No. The opportunity specified that there was no cost sharing or matching requirement.
Who was eligible to apply?
Eligible applicants included public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with 501(c)(3) status (other than institutions of higher education), and certain nonprofits without 501(c)(3) status (again, other than institutions of higher education).
When was the opportunity posted and when did it close?
It was posted and created on December 1, 2009. The original and current closing date was February 19, 2010.
When was the opportunity archived?
The archive date was March 22, 2010.
Is this a current funding opportunity?
Based on the provided dates (closing date February 19, 2010 and archive date March 22, 2010), this was a time-limited call and is not current.
Where were applicants directed for full details?
For full details, the opportunity pointed applicants to the NIH grants guide posting.
Who was listed for technical access issues?
The opportunity provided NIH Office of Extramural Research webmaster contacts for technical access issues.
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