Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT03554083
Phase
PHASE2
Status
Completed

Conditions

  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Pathologic Stage III Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIID Cutaneous Melanoma AJCC v8

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Cobimetinib — DRUG
    Given PO
  • Tiragolumab — BIOLOGICAL
    Given IV
  • Vemurafenib — DRUG
    Given PO

Study Details

This trial studies how well vemurafenib, cobimetinib, and atezolizumab work in treating patients with high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib, cobimetinib, and atezolizumab may work better in treating high-risk stage III melanoma. Giving atezolizumab and tiragolumab together may also work better in treating high-risk stage III melanoma.

Key Dates

Start date
Oct 5, 2018
Status verified
Apr 2026
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
64 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - CLOSED (vemurafenib, cobimetinib, atezolizumab)
    Patients receive vemurafenib PO BID on days 1-28 and cobimetinib PO QD on days 1-21. Patients also receive atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15 of cycles 2 and 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B - CLOSED (cobimetinib, atezolizumab)
    Patients receive cobimetinib as in Arm A and atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm C (atezolizumab, tiragolumab)
    Patients with BRAF wild-type or BRAF mutant melanoma receive atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Pathologic Complete Response Rate (pCR) [ Time Frame: 12 weeks ]

Locations (3)

FacilityCityStateZIP
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455
Mayo Clinic in RochesterRochesterMinnesota55905

Related coverage on Hipa.ai

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By research site
Mayo Clinic in Florida· Jacksonville, FLUniversity of Minnesota/Masonic Cancer Center· Minneapolis, MNMayo Clinic in Rochester· Rochester, MN

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