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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04698187
Phase
PHASE2
Status
Terminated

Conditions

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-001-010 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.

Key Dates

Start date
Mar 11, 2021
Status verified
Jun 2025
Primary completion
Feb 5, 2024
Completion
Feb 5, 2024

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
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.

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 24 months (107 weeks) ]

Locations (25)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
City of Hope National Medical Center, Robert Kang, MDDuarteCalifornia91010-
UCLA Hematology-OncologyLos AngelesCalifornia90095-
California Cancer Associates for Research & Excellence, Inc.San MarcosCalifornia92069-
University of Colorado- DenverDenverColorado80204-
Hartford HealthcareHartfordConnecticut06106-
GenesisCare USAJacksonvilleFlorida32204-
Orlando HealthOrlandoFlorida32806-
Cleveland Clinic FloridaWestonFlorida33331-
University Cancer & Blood CenterAthensGeorgia30607-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of IowaIowa CityIowa52242-
University of Louisville Health CareLouisvilleKentucky40202-
Massachusetts General HospitalBostonMassachusetts02114-
Columbia University Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Cancer InstituteDurhamNorth Carolina27710-
The Ohio State UniversityColumbusOhio43220-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Sammons Cancer CenterDallasTexas75246-
University of Utah- Huntsman Cancer InstituteSalt Lake CityUtah84112-
Seattle Cancer Care AllianceSeattleWashington98109-

Related coverage on Hipa.ai

Find similar trials in Phoenix, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Mayo Clinic· Phoenix, AZCity of Hope National Medical Center, Robert Kang, MD· Duarte, CAUCLA Hematology-Oncology· Los Angeles, CACalifornia Cancer Associates for Research & Excellence, Inc.· San Marcos, CAUniversity of Colorado- Denver· Denver, COHartford Healthcare· Hartford, CT

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