A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05116202
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab will be administered at a dose of 3 mg/kg IV on Day 1 of each 21 day cycle.
  • Ipilimumab — DRUG
    Ipilimumab will be administered at a dose of 1 mg/kg by IV on Day 1 of each 21 day cycle.
  • RO7247669 2100 mg — DRUG
    RO7247669 will be administered at a dose of 2100 mg by IV infusion on Day 1 of each 21 day cycle.
  • Atezolizumab — DRUG
    Atezolizumab will be administered at a dose of 1200 mg IV on Day 1 of each 21 day cycle.
  • Tiragolumab — DRUG
    Tiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21 day cycle.
  • RO7247669 600 mg — DRUG
    RO7247669 will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle.

Study Details

This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.

Key Dates

Start date
Feb 2, 2022
Status verified
Jun 2025
Primary completion
Sep 22, 2023
Completion
May 28, 2024

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1: Nivolumab + Ipilimumab
    Cohort 1 participants in the nivolumab plus ipilimumab arm will receive treatment for 2 cycles (6 weeks) on Day 1 of each cycle (cycle length 21 days) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
  • Experimental: Cohort 1: RO7247669 2100 mg
    Cohort 1 participants in the RO7247669 arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
  • Experimental: Cohort 1: + Atezolizumab + Tiragolumab
    Cohort 1 participants in the atezolizumab plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
  • Experimental: Cohort 1: RO7247669 2100 mg + Tiragolumab
    Cohort 1 participants in the RO7247669 plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
  • Experimental: Cohort 2: RO7247669 2100 mg + Tiragolumab
    Cohort 2 participants in RO7247669 plus tiragolumab arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
  • Experimental: Cohort 1: RO7247669 600 mg
    Cohort 1 participants in the RO7247669 arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
  • Experimental: Cohort 1: RO7247669 600 mg + Tiragolumab
    Cohort 1 participants in the RO7247669 plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.

Primary Outcome Measure

Pathologic Response Rate (pRR) for Cohort 1 as Determined by Independent Pathologic Review [ Time Frame: Time of surgery (scheduled at Week 7) ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
The Angeles Clinic and Research Institute - W LA OfficeLos AngelesCalifornia90025-
Moffitt Cancer CenterTampaFlorida33612-
MD Anderson Cancer CenterHoustonTexas77030-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
City of Hope· Duarte, CAThe Angeles Clinic and Research Institute - W LA Office· Los Angeles, CAMoffitt Cancer Center· Tampa, FLMD Anderson Cancer Center· Houston, TX

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