Melanoma - vemurafenib + cobimetinib - BRAF mutation

Association details:

Biomarker:	BRAF mutation
Cancer:	Melanoma
Drug:	Zelboraf (vemurafenib) (BRAF inhibitor, BRAF V600E inhibitor) + Cotellic (cobimetinib) (MEK1 inhibitor)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases

Excerpt:

...- Histologically confirmed metastatic melanoma (Stage IV), carrying BRAF V600-mutation...

Trial ID:

CoBRIM-B

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients

Excerpt:

...Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue BRAF V600 mutation test; 6....

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma

Excerpt:

...- Documentation of BRAF V600 test result mutation-positive status on melanoma tumor tissue using a validated tissue test...

Trial ID:

NCT02768207

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma

Excerpt:

...- Patients who have had prior therapy with a MEK inhibitor or an inhibitor of mutant BRAF are ineligible....

Trial ID:

NCT01813214

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

Excerpt:

...Confirmed diagnosis of a malignancy harbouring any actionable BRAF V600 mutation using an analytically validated sequencing technique (result does...

Trial ID:

DETERMINE

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases

Excerpt:

...- Histologically confirmed metastatic melanoma (stage IV, per AJCC staging), carrying BRAF V600-mutation...

Trial ID:

RadioCoBRIM

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases

Excerpt:

...BRAF V600 mutation positive....

Trial ID:

NCT02036086

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

Excerpt:

...- Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test...

Trial ID:

coBRIM

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation

Excerpt:

...Untreated and pretreated (no more than 1 treatment) patients with metastatic melanoma at stage unreseactable IIIb-IV, histologically confirmed, that show V600 type BRAF mutations....

Trial ID:

VEMUPLINT

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Clin Nucl Med

Title:

The Predictive Value of FDG PET/CT for Determining Progression-Free Survival in Advanced Stage III-IV BRAF-Mutated Melanoma Patients Treated With Targeted Therapy-What Can Be Learned From Progression?

Published date:

12/19/2023

Excerpt:

This prospective multicenter single-arm study included 70 patients with unresectable stage III/IV BRAF-mutated melanoma who underwent contrast-enhanced CT and 18F-FDG PET/CT at baseline and 2 and 7 weeks during treatment with vemurafenib plus cobimetinib...PERCIST median PFS was 15.7 months for patients with complete metabolic response (CMR) versus 8.3 months for non-CMR (P = 0.035).

DOI:

10.1097/RLU.0000000000004988

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Melanoma Res

Title:

Survival in adult patients with BRAFV600 mutation-positive advanced melanoma: a noninterventional ambispective study of patients with cobimetinib combined with vemurafenib during the French early access program: MELANIS study

Published date:

05/27/2022

Excerpt:

This noninterventional, ambispective, multicentre French study, conducted in patients previously registered in TAU, aimed to estimate overall survival (OS) and progression-free survival (PFS) and to describe the tolerability of the therapeutic combination....Median PFS was 7.3 months (95% CI, 5.2-8.4)....This study provides real-world outcomes in France for the vemurafenib-cobimetinib combination available in patients with BRAF-mutant-advanced melanoma.

DOI:

10.1097/CMR.0000000000000833