Duration of Anti-PD-1 Therapy in Metastatic Melanoma
ConditionUnresectable/Metastatic Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group
About this trial
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
Qualifiers
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.
Without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Intermittent PD-1 inhibitor therapy
- Continuous PD-1 inhibitor therapy
Treatment groups
614 Participants
are divided into 2 treatment groupsSponsors and collaborators
Canadian Cancer Trials Group
Lead sponsor
Melanoma and Skin Cancer Trials Limited
Collaborator
Source ClinicalTrials.gov