Checkmate_CMP-001-011 (1st line) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out how an experimental drug called CMP-001 works with nivolumab in your body and against your cancer. We will compare this drug combination to treatment with nivolumab alone.
Unresectable or metastatic melanoma
Who Can Participate in the Study?
- Have stage III or IV unresectable or metastatic melanoma
- Have not received a PD-1 blocking antibody
What is Involved?
The study has two parts: a screening period and a study dosing period.
If you choose to join this study, during the screening period you will:
- Have physical exams and blood draws
- Have imaging done (CT, MRI, photographs)
- Get an electrocardiogram
- Have a tumor biopsy done
If you're eligible for the study dosing period, you will:
- Receive the study drug(s) directly into your skin/tumor or through an IV
- Be randomized (like flipping a coin) into one of two groups
-- Group 1 will receive CMP-001 in combination with nivolumab
-- Group 2 will receive nivolumab on its own
- Return for a follow-up visit 100 days after the last study drug injection
- Have phone calls every 3 months after you finish the study treatment
If you decide to stop treatment before the study is done , we may ask you to come in for a few visits to take some images (CT or MRI). We will also call you every 3 months after you stop treatment until your doctor decides it is not necessary.