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.

What is the Condition Being Studied?

Unresectable or metastatic melanoma

Who Can Participate in the Study?

Adults who:
- Have stage III or IV unresectable or metastatic melanoma
- Have not received a PD-1 blocking antibody

Age Group
Adults

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.

Study Details

Full Title
A Randomized, Open-Label, Active-Control, Phase 2/3 Study of First-Line Intratumoral CMP-001 in Combination with Intravenous Nivolumab Compared to Nivolumab Monotherapy in Subjects with Unresectable or Metastatic Melanoma
Principal Investigator
Surgical Oncologist
Protocol Number
IRB: PRO00107061
NCT: NCT04695977
Phase
Phase II/III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698