Trial details

Trial short name: STOP GAP

Official title: A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma

Principal Investigator: Dr. Teresa Petrella

Cancer type: Melanoma
Cancer location: Melanoma
Disease stage: Early and Advanced Cancer
Trial phase: Phase 3
Intervention: Drug: PD-1 Inhibitor Therapy, Duration of Therapy

Registration #: NCT02821013

Contact e-mail: cancerclinicaltrials@sunnybrook.ca

Trial description:
The purpose of this study is to look at the duration of taking PD-1 inhibitor drugs in patients with metastatic melanoma. Patients with stage III or IV melanoma who are eligible to receive government approved and publicly funded PD-1 inhibitor may be able to participate. There will be two groups of patients participating in this study; one group will receive PD-1 inhibitor therapy continuously (as is the current standard of treatment) while the second group will receive PD-1 inhibitor therapy intermittently (taking breaks from treatment when the melanoma is better). Patients participating will know which treatment they are receiving but will be randomly allocated to one group or the other.

Inclusion Criteria: • Histologically confirmed melanoma that is unresectable / metastatic (stage III or stage IV). • Minimium age of 18 or as specified in the Product Monograph and eligible for public funding. • Eligible to receive treatment with a government approved and publically funded PD-1 inhibitor, according to the guidance / indications described in the Product Monograph / Provincial Formulary. • Patients must have evidence of unresectable / metastatic disease, that is considered evaluable by the investigator and can be followed, but measurable disease is not mandatory. • Patients with brain metastases are allowed, provided they are stable according to the following definitions: • Without evidence of progression by for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases. • Treated with surgery and without evidence of progression prior to randomization and have no evidence or new or enlarging brain metastases. • Treated with stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases. • In all cases above, patients should also not be on more than 10mg of prednisone or equivalent. • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to randomization. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible. • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. • Patients must be randomized prior to the start of, or within 3 weeks from the initiation of PD-1 inhibitor treatment. For patients who are being randomized before the start of treatment, the PD-1 inhibitor should be started within 2 working days after randomization. Exclusion Criteria: • Patients not willing to stop anti-PD-1 therapy, if randomized to the intermittent arm. • Patients with any contraindications to PD-1 inhibitors, as described in the Product Monograph or Provincial Formulary, and/or not eligible to receive anti-PD-1 therapy.