CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma

NCT04698187 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CMP-001-010
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 25

Brief Summary

CMP-001-010 is a Phase 2 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) administered to participants with refractory unresectable or metastatic melanoma. The primary objective of the study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. The secondary objectives are to:

• To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
• To evaluate the efficacy of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
• To assess the pharmacokinetic (PK) profile of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
• To assess and describe the immunogenicity of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.

Conditions

Melanoma; Advanced Melanoma; Metastatic Melanoma; Unresectable Melanoma

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 v1.1) as assessed by Blinded Independent Central Review (BICR)

  Up to approximately 24 months (107 weeks)

Secondary Outcomes (18)

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

  Up to approximately 24 months (107 weeks)

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

  Up to approximately 24 months (107 weeks)

• Time to Response (TTR) by BICR

  Up to approximately 28 months (122 weeks)

• Time to Response (TTR) by Investigator

  Up to approximately 28 months (122 weeks)

• Duration of Response (DOR) by BICR

  Up to approximately 28 months (122 weeks)

Study Arms (1)

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

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

Eligibility Criteria

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

You may qualify if:

• Histopathologically-confirmed diagnosis of malignant melanoma that is metastatic or unresectable at Screening.
• Known BRAF mutation status; if BRAF V600 mutation positive, must have had prior treatment with a local Health Authority approved BRAF inhibitor, with or without mitogen-activated protein kinase inhibitor. Patients with BRAF V600 mutations who refuse a BRAF inhibitor will not be eligible.
• Refractory to PD-1 blockade either as monotherapy or in combination with other therapies, as defined by the following criteria:
• Received treatment with a Food and Drug Administration approved PD-1 blocking antibody for 12 weeks or longer.
• Have PD (according to RECIST v1.1) within 12 weeks of the last dose of a PD-1 blocking antibody, either as monotherapy or in combination with other agents.
• Evidence of confirmed PD must be established by investigator assessment at least 4 weeks after the initial date of PD. The second assessment may serve as the Baseline for this study if completed within 30 days before to the start of study treatment. NOTE: in subjects with histologically confirmed recurrence on or after adjuvant PD-1 blocking antibody, confirmatory imaging is not required.
• Measurable disease, as defined by RECIST v1.1 and all 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.
• Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion.
• Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A fresh tissue biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable if no intervening therapy 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 first dose of study treatment on Week 1 Day 1 (W1D1):
• Bone marrow function:
• neutrophil count ≥ 1500/mm3
• platelet count ≥ 100,000/mm3

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 radiation therapy (or other nonsystemic therapy) within 2 weeks before first dose of study treatment on W1D1. Patients should have recovered (ie, Grade ≤1 or at baseline) from radiation-related toxicities.
• Treatment with complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before start of study treatment. Refer to Section 4.4. for prohibited therapies.
• Received systemic pharmacologic doses of corticosteroids ≥10 mg/day prednisone within 30 days before 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 before enrollment.
• Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
• Stress-dose corticosteroids will be required in subjects with adrenal insufficiency
• History of immune-related AE that required permanent discontinuation of PD-1 blocking antibody.
• Not fully recovered from AEs (to Grade 1 or less \[per CTCAE v5.0\], with the exception of persistent adverse events or sequelae, eg, vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency) due to prior treatment.
• NOTE: Subjects previously treated with a CTLA-4-blocking antibody, subjects receiving corticosteroids with daily doses \> 5 mg and ≤ 10 mg of prednisone equivalent for 2 weeks, and subjects with clinical symptoms and/or laboratory findings suggesting risk for adrenal insufficiency should undergo diagnostic tests for adrenal insufficiency via local laboratory.
• Active pneumonitis or history of noninfectious pneumonitis that required steroids.
• 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, or implanted or continuous use of a pacemaker or defibrillator.
• Known history of immunodeficiency.
• Known additional malignancy that is progressing or required active treatment within the past 3 years. Exceptions include cancers that have undergone potentially curative therapy, eg, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, 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, and thyroid cancer (except anaplastic), in situ breast cancer, and adjuvant hormonal therapy for breast cancer \> 3 years from curative-intent surgical resection.

Sponsors & Collaborators

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

Study Sites (25)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

City of Hope National Medical Center, Robert Kang, MD

Duarte, California, 91010, United States

Location

UCLA Hematology-Oncology

Los Angeles, California, 90095, United States

Location

California Cancer Associates for Research & Excellence, Inc.

San Marcos, California, 92069, United States

Location

University of Colorado- Denver

Denver, Colorado, 80204, United States

Location

Hartford Healthcare

Hartford, Connecticut, 06106, United States

Location

GenesisCare USA

Jacksonville, Florida, 32204, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

University Cancer & Blood Center

Athens, Georgia, 30607, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Louisville Health Care

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Columbia University Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Cancer Institute

Durham, North Carolina, 27710, United States

Location

The Ohio State University

Columbus, Ohio, 43220, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

University of Utah- Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Related Links

• A Plain Language Summary is available on TrialSummaries.com

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=100) for analysis per protocol. This was a business decision independent of safety/efficacy findings. Assessment of PK 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: January 6, 2021
• Study Start: March 11, 2021
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: June 11, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-06

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 (25)