Checkmate Pharmaceuticals is committed to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness.
Consistent with Checkmate’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach best serves patients who could be helped by the therapies we are developing. Further information about Checkmate’s clinical trials is available at Clinicaltrials.gov.
At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, Checkmate will consider requests from qualified physicians for pre-approval access to vidutolimod, an investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met.
Expanded Access Policy (EAP) provide a pathway for patients who are facing serious and life-threatening circumstances to gain access to investigational medicines for treatment outside of clinical trials when no comparable or satisfactory alternative therapy exists but their physician feels they should still try the investigational medicine. As part of our sustained commitment to patients, Checkmate may be able to provide access to an investigational medicine, under certain limited conditions, through our EAP. These conditions include the following:
- The patient has a serious or life-threatening illness or condition;
- There are either no appropriate, comparable, or satisfactory alternative treatments available, or the patient is no longer responsive to or no longer able to tolerate any available treatment option;
- The Checkmate investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
- A benefit-risk analysis, based on both the evolving clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
- Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
- Adequate supply of the investigational drug is available.
The safety and efficacy of vidutolimod is currently being evaluated in clinical trials for specific patient populations with cancer. At this time, we can only consider requests for single patient access to vidutolimod for use in patients who are ineligible for our existing enrolling trials and who have unresectable or metastatic (Stage II to IV) melanoma that is refractory to available treatments.
Checkmate is committed to evaluating all requests in a fair and equitable manner. To be considered for participation in the Checkmate EAP, all requests must be submitted by the patient’s treating physician. Checkmate may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring, and safety reporting. All requests will be considered on a case by case basis. Once a decision has been made, that decision will be final.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to:
ExpandedAccessRequests@checkmatepharma.com We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt.