Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC

Sponsor
University Hospital Tuebingen
Study ID
NCT02303951
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Vemurafenib — DRUG
    Run-In: Day 1-21 960 mg bid orally, Day 22-28 720 mg bid orally Triple-Treatment (week 5 ongoing): 720 mg bid orally
  • Cobimetinib — DRUG
    Run-In: Day 1-21 60 mg od orally Triple-Treatment (week 5 ongoing): 60 mg od 21/7 orally (3 weeks on drug, 1 week off)
  • Atezolizumab — DRUG
    Triple-Treatment (week 5 ongoing): 840 mg Q2W i.v

Study Details

Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with vemurafenib + cobimetinib + atezolizumab in patients with limited metastasis of melanoma in stage IIIC/IV melanoma.

Key Dates

Start date
Jan 22, 2015
Status verified
May 2020
Primary completion
May 14, 2020
Completion
May 14, 2020

Study Design

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

Arms

  • Experimental: vemurafenib + cobimetinib + atezolizumab
    Run-In (week 1-4): * Day 1-21: vemurafenib 960 mg bid orally + cobimetinib 60 mg od orally * Day 22-28: vemurafenib 720 mg bid orally Triple-Treatment (week 5 ongoing): atezolizumab 840 mg Q2W i.v. + vemurafenib 720 mg bid orally + cobimetinib 60 mg od 21/7 orally (vemurafenib: daily intake; cobimetinib: 3 weeks on drug, 1 week off)

Primary Outcome Measure

Percent of patients who actually become resectable and are resected [ Time Frame: Following 18 weeks of combined treatment ]

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