DoD Kidney Cancer, Clinical Consortium – Clinical Trial Site Award

This year the KCRP is offering the Clinical Consortium – Clinical Trial Site Award (CTSA) mechanism to support the inclusion of new Clinical Trial Sites to the existing Kidney Cancer Research Consortium (KCRC).

The FY20 KCRP CTSA is intended to support a major goal, a consortium of exceptional institutions and leading investigators to advance high-impact, novel therapeutic strategies and interventions to improve patient outcomes and significantly decrease the impact of the disease (the “Consortium”).

The objectives of the Consortium shall be to design, develop, and conduct Phase I or Phase II-linked Phase I (Phase I/II) clinical trials of promising therapeutic agents for the prevention, detection/diagnosis, management, or treatment of kidney cancer.

The KCRP CTSA provides the support to develop and enhance collaborations and resources necessary for a network of organizations to rapidly execute investigator-initiated kidney cancer clinical trials. Support from this award is directed toward Consortium infrastructure needs rather than direct support of the research itself.

Applicants should be knowledgeable of the current state of clinical studies and clinical priorities related to kidney cancer and are encouraged to familiarize themselves with the KCRP Strategic Plan, and to consider this material when preparing their application. The FY20 KCRP CTSA mechanism is designed to fund up to two new Clinical Trial Sites, each through separate awards.

FY19 KCRP CTSA awardees are not eligible to apply for this FY20 KCRP CTSA. The Clinical Trial Sites will merge with the newly established KCRC and will be jointly responsible for proposing, selecting, and conducting Phase II and Phase I/II clinical trials focused on kidney cancer therapeutic interventions. The existing Consortium consists of one Coordinating Center and three Clinical Trial Sites.

Additional details regarding the structure of the Consortium are described below. The Coordinating Center, in addition to functioning as a Clinical Trial Site, serves as the Consortium information and planning nexus providing administrative, operational, and data management support services to participating Clinical Trial Sites to implement Consortium clinical trials in a timely manner.

Responsibilities of the Coordinating Center include coordinating the clinical trial selection process; protocol coordination; regulatory coordination; study management and monitoring; data collection, management, and statistics; and intellectual/material property coordination.

In addition, the Coordinating Center coordinates and promotes best practices for human subject recruitment and aids Clinical Trial Sites in directing potential subjects to the most appropriate trials. All Sites (Clinical Trial Sites and the Coordinating Center) are required to participate in at least two of the KCRC’s new or ongoing clinical trials at all times.

Collectively, the Coordinating Center Principal Investigator (PI), the PI from each Clinical Trial Site, and consumer advocates constitute the Clinical Consortium Steering Committee. The consumer advocates must be kidney cancer patients, or caretakers for someone with kidney cancer, and possess a high-level familiarity with current issues in kidney cancer research.

The consumer advocates’ role in the committee should be independent of their employment with a participating institution. During the KCRC’s period of performance, the Coordinating Center PI chairs the Steering Committee. The Clinical Consortium Steering Committee collaboratively develops and maintains procedures for the selection of clinical trials to be implemented within the Consortium.

The KCRP Grants Officer Representative (GOR) must be invited to meetings of the Clinical Consortium Steering Committee as well as any other formal meetings of the KCRC. All Sites are responsible for working collaboratively to identify new clinical trials for implementation. Any Site may serve as an entry point for clinical trials that originate from outside the Consortium.

The Coordinating Center is responsible for facilitating the entire process. The Consortium should leverage other Department of Defense (DoD) investment opportunities whenever possible (e.g., to support correlative studies, clinical trial PIs are strongly encouraged to apply for translational awards offered by the DoD).

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 (https://health.

mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY20 KCRP priorities. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.

Key requirements of the FY20 KCRP Clinical Consortium – Clinical Trial Site Award are listed below. Additional information regarding the responsibilities of the current KCRC Coordinating Center can be found within the FY19 KCRP Program Announcement W81XWH-19-KCRP-CCA on pages five and six.

 Responsibilities of the Consortium Participants: Procedures for the Consortium, while managed by the Coordinating Center, will be fully developed and agreed upon by all participants working collaboratively. At the discretion of the Government, a pre-award planning meeting may be required. ○ Coordinating Center.

The responsibilities of the established Coordinating Center for the KCRC can be found within the FY19 KCRP Program Announcement W81XWH-19-KCRP-CCA on pages five and six. ○ Clinical Trial Sites.

The responsibilities of each Site include:– If required by the Government, participation in a pre-award planning meeting with all Consortium members to discuss operational features of the Consortium, the requirements for progress and evaluation, and the award negotiations process.

– Full participation in the Consortium, including but not limited to, clinical trial introduction and selection, patient accrual for Consortium studies (to consider disproportionately affected populations [see https://seer. cancer. gov]), data collection and timely submissions, meeting attendance, and adherence to the Consortium’s operating procedures.

– Presentation of at least two clinical trials for the Consortium’s consideration per year. – Meeting minimum accrual requirements of 15 patients per year across open and recruiting KCRC clinical trials, either independently or in partnership with other non-Consortium institutions.

At least 20% of these patients must be contributions to trials from other Consortium Sites, and at least 5% of all accrued patients at each site must be from disproportionately affected populations.

Provision for a Clinical Trial Coordinator, who will interact with the Clinical Trial Coordinators of other Clinical Trial Sites and the Supervising Clinical Trial Coordinator of the Coordinating Center to expedite and guide clinical protocols through the regulatory approval processes, to coordinate patient accrual and study activities across Sites, and foster communication with other Consortium Clinical Trial Coordinators.

– Implementation of the Consortium’s core data collection methodology and strategies. – Compliance with Consortium-developed quality assurance and quality control procedures, as appropriate, including: Participation in a monitoring program to be managed by the Coordinating Center.  Implementation of the Consortium-developed management plan for acquisition, delivery, and storage of biological samples and study data.

 Submission of appropriate data and materials to allow for verification and review of protocol-related procedures, for example, pathology, imaging techniques, surgical methods, and therapeutic use. – Implementation of procedures established by the Coordinating Center for ensuring compliance with FDA requirements for investigational agents, as appropriate.

– Implementation of procedures established by the Coordinating Center to meet the local Institutional Review Board (IRB) requirements for the conduct of clinical trials and the protection of human subjects. – Participation in Consortium-developed procedures for the timely publication of major findings.

– Participation in Consortium-developed procedures for resolving intellectual and material property issues among institutions participating in the Consortium. – Participation in ongoing review by the Consortium’s External Advisory Board (EAB). – Submission of annual written progress reports, a final written comprehensive report, and any other reports required by the Government to be outlined in the assistance agreement.

– Additional responsibilities based on recommendations and guidance from the consortium EAB and U.S. Army Medical Research and Development Command (USAMRDC) staff.  Performance Metrics: Exercise of the option for continued performance of each participant Site after the first year will be contingent upon meeting performance metrics as specified in the award agreements.

○ Metrics for Clinical Trial Site Performance– Accrual of at least 15 patients per year across open and recruiting Consortium clinical trials, either independently or in partnership with other non-Consortium institutions. – Participation in a minimum of two trials, at all times, initiated by any of the Consortium Sites. – Presentation of at least two trials per year to the Consortium for consideration.

– Timely submission of quality data as outlined by the Coordinating Center. The types of awards made under the Program Announcement will be assistance agreements.

An assistance agreement is appropriate when the Federal Government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. Government. An assistance agreement can take the form of a grant or cooperative agreement.

The level of involvement on the part of the DoD during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304).

Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award.

The award type, along with the start date, will be determined during the negotiation process. The anticipated direct costs budgeted for the entire period of performance for an FY20 KCRP Clinical Consortium – Clinical Trial Site Award will not exceed $300,000 per year for a maximum of $600,000 for the entire 2-year performance period. Refer to Section II.

D. 5, Funding Restrictions, for detailed funding information. Awards will be made no later than September 30, 2021.

For additional information refer to Section II. F. 1, Federal Award Notices.

The CDMRP expects to allot approximately $1. 92M over a 2-year period to fund approximately two Clinical Consortium – Clinical Trial Site Award applications. A total of $960,000 will be allocated from the FY20 KCRP budget to fund the first year of performance.

Options will be included for continued performance in the following year, with $960,000 expected from each of the FY21 KCRP anticipated Congressional appropriations. The initial performance period of the award and the following option period will be for 12 months.

Funding of applications received is contingent upon the availability of Federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the Government.

Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY20 funding opportunity will be initially funded with FY20 funds, which will expire for use on September 30, 2026.

Exercise of the option for continued performance is contingent upon receipt of sufficient Congressional appropriations for the KCRP in FY21, with anticipated funds expiring for use on September 30, 2027. Funding Opportunity Number: W81XWH-20-KCRP-CTSA. Assistance Listing: 12.

420. Funding Instrument: CA,G. Category: ST.

Award Amount: $1. 9M total program funding.