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

NCT04695977 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CMP-001-011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Melanoma; Advanced Melanoma; Metastatic Melanoma; Unresectable Melanoma

Keywords

vidutolimod

Outcome Measures

Primary Outcomes (1)

• Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)

  ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST vl.l) as assessed by Blinded Independent Central Review (BICR)

  Up to approximately 39 months

Secondary Outcomes (10)

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death

  Up to approximately 28 months (122 weeks)

• Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  Up to approximately 28 months (122 weeks)

• Time to Response (TTR) by BICR

  Up to approximately 39 months

• Time to Response (TTR) by Investigator

  Up to approximately 39 months

• Duration of Response (DOR) by BICR

  Up to approximately 39 months

Study Arms (2)

CMP-001 and Nivolumab

EXPERIMENTAL

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

Drug: CMP-001; Drug: Nivolumab

Nivolumab Monotherapy

EXPERIMENTAL

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

Drug: Nivolumab

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).

Also known as: vidutolimod

CMP-001 and Nivolumab

Nivolumab DRUG

Nivolumab 360 mg IV is administered Q3W.

Also known as: OPDIVO

CMP-001 and Nivolumab; Nivolumab Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma per AJCC Cancer Staging Manual Eighth Edition.
• Measurable disease, as defined by RECIST v1.1 and both of the following:
• At least 1 accessible lesion amenable to repeated IT injection
• One or more measurable lesions at least 1 cm in diameter that are not intended for CMP-001 injection and can be followed as target lesions per RECIST v1.1
• Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the first dose of study treatment) is preferred, but an archival sample is acceptable if no intervening therapy for melanoma/cancer was received. Note: for tissue sampling details, please refer to the Laboratory Manual.
• Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study treatment on Week 1 Day 1 (W1D1):
• Bone marrow function:
• neutrophil count ≥1500/mm3
• platelet count ≥ 100 000/mm3
• hemoglobin concentration ≥9 g/dL
• white blood cells ≥2000/mm3
• Liver function:
• total bilirubin ≤1.5 × the upper limit of normal (ULN) with the following exception: subjects with Gilbert Disease total serum bilirubin ≤3 × ULN
• aspartate aminotransferase and alanine aminotransferase ≤3 ×ULN
• Lactate dehydrogenase ≤2 × ULN

You may not qualify if:

• Subjects presenting with any of the following will not qualify for entry into the study:
• Uveal, acral, or mucosal melanoma.
• Received prior systemic treatment for melanoma in the unresectable or metastatic setting. Prior adjuvant therapy is acceptable if the treatment course (of approximately 1 year duration) was completed and there was no recurrence within 6 months of the last dose of adjuvant treatment.
• Received prior therapy with CMP-001.
• Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study treatment on W1D1.
• Subjects who are currently receiving steroids at a prednisone-equivalent dose of ≤10 mg/day do not need to discontinue steroids prior to enrollment.
• Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
• History of CTCAE v5.0 Grade 4 immune-related AE due to adjuvant CTLA-4 or PD-1 blocking antibody.
• Not fully recovered from adverse events (to Grade 1 or less \[per CTCAE v5.0\], with the exception of persistent alopecia, adrenal insufficiency, and hypothyroidism) due to prior treatment.
• Active pneumonitis, history of pneumonitis that required steroids, or history of interstitial lung disease.
• Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, and implanted or continuous use of a pacemaker or defibrillator.
• Known history of immunodeficiency.
• Known additional malignancy that has progressed or required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, curatively treated localized prostate cancer with prostate-specific antigen level below 4.0 ng/mL, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, thyroid cancer (except anaplastic), and adjuvant hormonal therapy for breast cancer \>3 years from curative-intent surgical resection.
• Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
• Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Bristol-Myers Squibb: collaborator

Study Sites (20)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Moores Cancer Center at UC San Diego Health

La Jolla, California, 92093, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

Location

California Cancer Associates for Research & Excellence, Inc.

San Marcos, California, 92069, United States

Location

Hartford Healthcare

Hartford, Connecticut, 06106, United States

Location

Cleveland Clinic

Weston, Florida, 33331, United States

Location

University Cancer & Blood Center

Athens, Georgia, 30607, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Louisville Health Care

Louisville, Kentucky, 40202, United States

Location

Atlantic Health

Morristown, New Jersey, 07960, United States

Location

Duke University Cancer Institute

Durham, North Carolina, 27710, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center / Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Texas Oncology, Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The study stopped before reaching sample size as originally planned (n=140) for analysis per protocol. This was a business decision independent of safety/efficacy findings. Assessment of PK and immunotherapy was not conducted.

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: January 6, 2021
• Study Start: February 24, 2021
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (20)