EVOLUTIONARY THERAPY
Request for Application (RFA)
Submission deadline - 1 March 2021, 23:59 CET
_closed call_
Scope of this RFA
This Request for Application (RFA) seeks to increase clinical trial activity of evolutionarily informed therapeutic strategies aiming at improving survival outcomes of cancer patients.
Knowledge about tumour evolutionary dynamics has been growing rapidly. However, there has been a limited translation of that knowledge into therapeutic trials. The most clinically advanced strategy is adaptive therapy. Adaptive therapy is a treatment strategy attempting to prolong response to treatment by delaying the emergence of resistance. The goal of adaptive therapy is to maintain a controllable stable tumour burden by allowing a significant population of treatment-sensitive cells to survive. The main principle of the intervention is to control the tumour and prolong survival by allowing on/off treatment periods based on a valid marker.
This RFA will accept clinical trials on adaptive therapy and any other evolutionarily informed strategy, as long as they meet all criteria (see eligibility criteria below).
We encourage investigators working on evolutionarily informed strategies (including adaptive therapy) to apply for funding for their clinical trial evaluating such approach in cancer patients.
For further information on what is seen as evolutionarily informed strategies and adaptive therapy, we would like to refer applicants to a recent article by Gatenby & Brown (Gatenby RA, Brown JS. Integrating evolutionary dynamics into cancer therapy. Nat Rev Clin Oncol 2020; 17: 675–86).
Eligibility criteria
Clinical trials are eligible if they meet all of the following criteria:
- Trial needs to be an interventional clinical trial based on an adaptive and/or evolutionarily informed approach (see scope).
- Trial in any cancer type, but with a well-defined and valid patient/tumour-specific marker that illustrates tumour dynamics.
- Trial should serve patients’ interest and be patient-centred.
- Trial must contain patient-reported outcomes measurements and quality of life assessments.
- The clinical trial team has a track record of performing high-quality trials – preferentially investigator-driven trials.
- There should be no trial competing for the same patient population in the participating centres and/or countries.
- There is no geographical restriction. All nationalities and countries are permitted to submit their proposals. International clinical trials are permitted.
- Trial should have an accrual period of max. 3 years.
- The ultimate goal of the intervention is to improve survival. However, the trial submitted can be an early phase trial not powered for survival but looking at a biological, translational, clinical or safety primary endpoint.
- All interventions are allowed, except:
- Compounds (chemical/biological) that are still in drug development are not permitted.
- Drug products not approved for any indication (cancer or not cancer related indication) are not permitted. - Interventions must be reimbursed by national health care system for the specific disease setting within the trial. Drug products provided by the company for the trial are also accepted.
Applications will be automatically rejected if the applicant omits disclosure of secured funding or ongoing funding applications for the same trial.
We encourage applicants to contact apply@anticancerfund.org for any question related to the RFA or to check eligibility of their proposal in case of doubt.
Budget
- The budget must be realistic and limited to the core activity of conducting the clinical trial.
- Investigator fees and institutional overhead costs are not accepted.
- Budget for translational work should be limited.
- Co-funding is welcome. All applicants must disclose the funding already secured and all past and ongoing funding applications.
We foresee a total budget of 1.5M €, we anticipate supporting up to 3 trials with this budget.
Submission and selection process
This is a 2-step RFA
- Step 1: applicants are requested to submit a Letter of Intent (LOI).
- Step 2: after a pre-feasibility call with ACF, applicants are requested to submit a full application, i.e. a trial protocol (ready or almost ready to be submitted to authorities and IRB/ethics committee), a detailed budget and a rebuttal letter on feedback about the LOI.
Step 1: Letter of Intent (LOI)
We ask all applicants to complete a LOI form which includes 2 main sections:
- The eligibility section where applicants demonstrate that their proposal meets all the above-mentioned criteria.
- The trial information section where applicants provide details on their proposal.
-- Deadline for submission of the LOI is Monday 1 March 2021, 23:59 CET --
The evaluation of the LOIs will be done by the ACF team and will include
- Checking the eligibility criteria
- Evaluating the scientific rationale and the possible existence of counterevidence
- Performing horizon scanning to assess competition
From all applications, we expect to select 5 applications to go forward to step 2.
Applicants will be notified whether their LOI has been selected to proceed to Step 2 by 1 April 2021.
Step 2: Full Application
Step 2 starts with a teleconference between the ACF team and the applicant. The goal of this teleconference is to explain the process, perform a preliminary evaluation of the feasibility for running the trial, and assess whether any circumstances have changed since receipt of the LOI.
After the teleconference, the applicants will be asked to submit a full application containing:
- Protocol: we ask the applicants to submit a protocol ready (or almost ready) to be submitted to the competent authorities and to the IRB/EC;
- Budget: detailed breakdown of the budget;
- Rebuttal: we might ask further elaboration on specific questions and/or concerns that arose during the evaluation of the LOI.
-- Deadline for full application is Tuesday 1 June 2021, 23:59 CET --
The evaluation of the full applications will be done by a grant review committee (GRC) consisting of experts in the field as well as patient representatives.
The final selection is expected to be communicated on 31 August 2021. Selected applications will receive a conditional go. The final go and signing of the collaboration agreement will only be after a final assessment on the feasibility of running the trial and a site visit.
Key dates
- Deadline Letter of Intent: 1 March 2021
- Selection step 2: 1 April 2021
- Deadline Full Application: 1 June 2021
- Final decision: 31 August 2021
Questions?
Please send us an e-mail at apply@anticancerfund.org or give us a call on +32 2 268 48 16.
We encourage applicants to contact us for any question related to the RFA or to check eligibility of their proposal, in case of doubt.