CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma

Conditions

• Advanced Melanoma
• Melanoma
• Metastatic Melanoma
• Unresectable Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CMP-001 — DRUG
  Subjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W).
• Nivolumab — DRUG
  Nivolumab 360 mg IV is administered Q3W.

Study Details

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.

Key Dates

Start date

Feb 24, 2021

Status verified

Aug 2025

Primary completion

Jul 22, 2024

Completion

Jul 22, 2024

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 39 months ]

Locations (20)

Related coverage on Hipa.ai

• Nivolumab Monotherapy Outperforms Combination in Advanced Melanoma Trial
  Nivolumab · Sep 5, 2025 · ClinicalTrials.gov

Find similar trials in Phoenix, AZ

Related Studies

• A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
  PHASE1/PHASE2 · Recruiting · University of Louisville · Louisville, Kentucky
• Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• In Vivo Real-time Detection of Circulating Melanoma Cells
  Recruiting · University of Arkansas · Little Rock, Arkansas
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado