CMP-001 + Nivolumab for Melanoma

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Checkmate Pharmaceuticals

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma. The study is divided into two phases: Phase 2 and Phase 3. The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma. The secondary objectives of Phase 3 are to: * To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. * To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.

Eligibility Criteria

Adults with advanced melanoma that hasn't spread to the eyes, hands, feet or mucous membranes. They haven't had systemic treatment for metastatic melanoma and have no history of certain allergies or immune deficiencies. Participants must not be pregnant, should use contraception, and have good organ function.

Inclusion Criteria

I understand and can follow the study's requirements.

I am a man who is either surgically sterile or using reliable birth control.

Able and willing to provide written informed consent and to follow study instructions

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Exclusion Criteria

I am allergic to nivolumab or its ingredients.

Participation in another clinical study of an investigational anticancer therapy or device within 30 days before the first dose of study treatment

I have not received blood products or growth factors in the last 30 days.

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Treatment Details

Interventions

CMP-001 (Virus Therapy)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing CMP-001 given directly into tumors combined with Nivolumab via IV versus just Nivolumab alone. It aims to see if the combination works better for treating unresectable or metastatic melanoma without surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Nivolumab MonotherapyExperimental Treatment1 Intervention

All enrolled subjects will receive nivolumab monotherapy IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Group II: CMP-001 and NivolumabExperimental Treatment2 Interventions

All enrolled subjects will receive CMP-001 IT and nivolumab IV according to the treatment schedule until a reason for treatment discontinuation is reached.