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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04633278
Phase
PHASE2
Status
Terminated

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg IV is administered Q3W.

Study Details

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.

Key Dates

Start date
Jan 21, 2021
Status verified
May 2025
Primary completion
Jan 19, 2024
Completion
Jan 19, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 109 weeks ]

Locations (19)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
University of California - San DiegoLa JollaCalifornia92093-
UCLA Hematology-OncologyLos AngelesCalifornia90095-
University of Southern California - Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of Southern California: Norris Oncology/Hematology - Newport BeachNewport BeachCalifornia92663-
University Cancer & Blood CenterAthensGeorgia30607-
University of Chicago Medical CenterChicagoIllinois60637-
University of Iowa Hospitals & ClinicsIowa CityIowa52242-
Massachusetts General HospitalBostonMassachusetts02114-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Nebraska Methodist HospitalOmahaNebraska68114-
Atlantic HealthMorristownNew Jersey07960-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
UPMC - Hillman Cancer CenterPittsburghPennsylvania15232-
Bon Secours St. Francis Cancer CenterGreenvilleSouth Carolina29607-
University of TennesseeKnoxvilleTennessee37920-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Houston Methodist Hospital/Cancer CenterHoustonTexas77030-
University of Vermont Medical CenterBurlingtonVermont05401-

Related coverage on Hipa.ai

Find similar trials in Little Rock, AR

By research site
University of Arkansas for Medical Sciences· Little Rock, ARUniversity of California - San Diego· La Jolla, CAUCLA Hematology-Oncology· Los Angeles, CAUniversity of Southern California - Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of Southern California: Norris Oncology/Hematology - Newport Beach· Newport Beach, CAUniversity Cancer & Blood Center· Athens, GA

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