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Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

NCT02902029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-04-09

No results posted yet for this study

Summary

Most patients with locally advanced or metastatic tumors succumb to their disease. Thus, there is a substantial need for novel therapeutic strategies to improve the outcome for patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an antiPD-L1 antibody have emerged as treatment option.

In this study the best timing for sequential use of both treatment options (BRAF/MEK inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600 mutant melanoma will be assessed.

Conditions

  • Malignant Melanoma

Interventions

DRUG

Vemurafenib

960 mg vemurafenib BID until progression or unacceptable toxicity develops

DRUG

Cobimetinib

60 mg cobimetinib QD, 21/7 until progression or unacceptable toxicity develops

DRUG

Atezolizumab

1200 mg atezolizumab administered intravenously on day 1 of each 21 day-cycle. Will be given until progression or unacceptable toxicity develops

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Dirk Schadendorf, Prof. Dr. · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • France
  • Germany
  • Greece
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02902029 on ClinicalTrials.gov