Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma

Sponsor
Fondazione Melanoma Onlus
Study ID
NCT04722575
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Cobimetinib 20 MG Oral Tablet — DRUG
    Cobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off.
  • Vemurafenib 240 Mg Oral Capsule — DRUG
    960 (arm A) /720 (arm B) mg bid p.o. from week 1 to week 6.
  • Atezolizumab 1200 MG in 20 ML Injection — DRUG
    840 mg IV for 2 cycles for Arm B and C. After surgery in all arms 1200 mg IV for 52 weeks

Study Details

Neoadjuvant plus adjuvant treatment with target therapy and immunotherapy given in combination or sequence may have an anti-tumour activity and may reduce the risk of relapse in patients with high-risk resectable melanoma (stage III B / C / D and oligometastatic stage IV).

Key Dates

Start date
Oct 12, 2020
Status verified
Mar 2025
Primary completion
Dec 15, 2023
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: ARM A
    Arm A BRAF mutated patients. Over a period of 6 weeks (1) + (2): 1. Vemurafenib 960 mg bid p.o. from week 1 to week 6. 2. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off. After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks
  • Experimental: ARM B
    Arm B BRAF mutated patients. Over a period of 6 weeks (1) + (2) + (3): 1. Vemurafenib 720 mg bid p.o. from week 1 to week 6. 2. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and from week 5 to week 6. Week 4 off. 3. Atezolizumab 840 mg IV for 2 cycles (day 1 of week 4 and day 1 of week 7). After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks
  • Experimental: ARM C
    Arm C BRAF WT patients. Over a period of six weeks (1) + (2): 1. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and from week 5 to week 6, 2. Atezolizumab 840 mg IV for 2 cycles (day 1 of week 1 and day 1 of week 4). After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks

Primary Outcome Measure

Pathologic Complete Response (pCR) rate (Centrally/Independently determined) [ Time Frame: At surgery (from week 8 to week 9) ]

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