CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT04633278 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CMP-001-007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 19

Brief Summary

CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC) The secondary objectives are to:

• To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC
• To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC
• To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Head and Neck Cancer; Pembrolizumab; Carcinoma; HNSCC

Outcome Measures

Primary Outcomes (1)

• Confirmed Objective Response Rate (ORR)

  Confirmed ORR is defined as the percentage of participants with a 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 determined by Investigator assessment (IA).

  Up to approximately 109 weeks

Secondary Outcomes (14)

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

  Up to approximately 109 weeks

• Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0

  Up to approximately 109 weeks

• Duration of Response (DOR)

  Up to approximately 28 months (120 weeks)

• Duration of Progression-free Survival (PFS)

  Up to approximately 28 months (120 weeks)

• Duration of Overall Survival (OS)

  From first dose up to approximately 28 months (120 weeks)

Study Arms (1)

CMP-001 and Pembrolizumab

EXPERIMENTAL

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

Drug: CMP-001; Drug: Pembrolizumab

Interventions

CMP-001 DRUG

Subjects will receive CMP-001 10mg weekly for 2 doses after which CMP-001 will be administered every 3 weeks. The first dose of CMP-001 may be administered subcutaneously (SC) or Intratumorally (IT) at the discretion of Investigator. All subsequent doses will be injected intratumorally every 3 weeks (Q3W).

Also known as: vidutolimod

CMP-001 and Pembrolizumab

Pembrolizumab DRUG

Pembrolizumab 200 mg IV is administered Q3W.

Also known as: Keytruda

CMP-001 and Pembrolizumab

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 recurrent or metastatic HNSCC considered incurable by local therapies.
• No prior systemic therapy in the recurrent or metastatic setting. Systemic therapy as part of multi-modal treatment for locally advanced disease is allowed.
• Primary tumor locations of oropharynx, oral cavity, hypopharynx, larynx or paranasal sinus. Participants may not have a primary tumor site of nasopharynx (any histology).
• 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 start of study treatment) is preferred but an archival sample is acceptable.
• Combined Positive Score (CPS) ≥ 1 for PD-L1 on Immunohistochemistry (IHC) of tumor tissue.
• Have results of tumor HPV p16 by IHC for oropharyngeal cancer.
• Measurable disease as defined by RECIST v1.1, and both of the following:
• At least 1 lesion amenable to repeated Intratumoral (IT) injection.
• Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion.
• Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study drug on Week 1 Day 1 (W1D1) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening.
• Capable of understanding and complying with protocol requirements.
• Women of childbearing potential must have negative serum pregnancy test during Screening and be willing to use an adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug.
• Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug.
• Able and willing to provide written informed consent and to follow study instructions.
• Subjects unable to provide written informed consent on their own behalf will not be eligible for the study.

You may not qualify if:

• Disease suitable for local therapy administered with curative intent.
• Has PD within 3 months of completion of curatively intent systemic treatment for locoregionally advanced HNSCC.
• Radiation therapy (or other non-systemic therapy) within 2 weeks before the first dose of study drug on W1D1.
• Received prior therapy with PD-1 or PD-L1 blocking antibody therapy in the recurrent/ metastatic setting. If PD-1 or PD-L1 blocking antibody therapy was given as part of curative intent therapy, it must be at least 1 year since receipt of PD-1 or PD-L1 blocking antibody.
• Not fully recovered from adverse events (to Grade 1 or less \[per CTCAE v5.0\]), with the exception of persistent alopecia, neuropathy, ototoxicity, hypothyroidism, pain, or dysphagia, due to prior treatment.
• Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study drug 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.
• Active pneumonitis, history of noninfectious 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, 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 basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, and thyroid cancer (except anaplastic).
• 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 (CNS) metastases or carcinomatous meningitis.
• Prior allogenic tissue/solid organ transplant.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (19)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California - San Diego

La Jolla, California, 92093, United States

Location

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

UCLA Hematology-Oncology

Los Angeles, California, 90095, United States

Location

University of Southern California: Norris Oncology/Hematology - Newport Beach

Newport Beach, California, 92663, United States

Location

University Cancer & Blood Center

Athens, Georgia, 30607, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Atlantic Health

Morristown, New Jersey, 07960, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

UPMC - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Bon Secours St. Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Houston Methodist Hospital/Cancer Center

Houston, Texas, 77030, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Links

• A Plain Language Summary is available on TrialSummaries.com

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Carcinoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Limitations and Caveats

Per sponsor's decision, enrollment was stopped before reaching the full sample size as originally planned for the analyses described in the protocol. This was a development decision independent of the safety or efficacy profile/findings associated with the study. All analyses are hence exploratory. The performance of the statistical analysis for the protocol objectives and endpoints of the exploratory phase 2 study is limited by the limited availability of the data source.

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: October 26, 2020
• First Posted: November 18, 2020
• Study Start: January 21, 2021
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: May 11, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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 (19)