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Recruiting Phase 3 NCT02821013

Duration of Anti-PD-1 Therapy in Metastatic Melanoma

Trial Parameters

Condition Unresectable/Metastatic Melanoma
Sponsor Canadian Cancer Trials Group
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 614
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2016-10-31
Completion 2027-12-31
Interventions
Intermittent PD-1 inhibitor therapyContinuous PD-1 inhibitor therapy

Brief Summary

The purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.

Eligibility Criteria

Minimum age 18 or as specified in the Product Monograph and eligible for public funding. Inclusion Criteria: * Histologically confirmed melanoma that is unresectable / metastatic (stage III or stage IV). * 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: 1. Without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases. 2. Treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases. 3. Treated with stereotacti

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