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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Published date:
11/20/2015
Excerpt:
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
...Other regimens (for patients with BRAF V600-activating mutation) with the following agents - Dabrafenib/trametinib...vemurafenib/cobimetinib...Encorafenib/Binimetinib...
Evidence Level:
Sensitive: B - Late Trials
Title:

5-Year Outcomes with Cobimetinib Plus Vemurafenib in BRAF V600 Mutation-Positive Advanced Melanoma: Extended Follow-Up of the coBRIM Study

Published date:
06/22/2021
Excerpt:
Median OS was 22.5 months (95% CI, 20.3-28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0-19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5-14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6-7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. Extended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAF V600 mutation-positive advanced melanoma.
DOI:
10.1158/1078-0432.CCR-21-0809
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

Excerpt:
In this double-blind, randomised, placebo controlled, multicentre study, adult patients (aged ≥18 years) with histologically confirmed BRAF V600 mutation-positive unresectable stage IIIC or stage IV melanoma were randomly assigned (1:1) using an interactive response system to receive cobimetinib (60 mg once daily for 21 days followed by a 7-day rest period in each 28-day cycle) or placebo, in combination with oral vemurafenib (960 mg twice daily)....495 eligible adult patients were enrolled and randomly assigned to the cobimetinib plus vemurafenib group (n=247) or placebo plus vemurafenib group (n=248)….At a median follow-up of 14·2 months (IQR 8·5–17·3), the updated investigator-assessed median progression-free survival was 12·3 months (95% CI 9·5 13·4) for cobimetinib and vemurafenib versus 7·2 months (5·6–7·5) for placebo and vemurafenib (HR 0·58 [95% CI 0·46–0·72], p<0·0001).
DOI:
https://doi.org/10.1016/S1470-2045(16)30122-X
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Radiation Use During Vemurafenib Treatment

Excerpt:
...- Diagnosis of BRAFV600 mutated Stage IV or unresectable Stage III melanoma...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Clinical Trial to Evaluate the Efficacy of Vemurafenib in Combination With Cobimetinib (Continuous and Intermittent) in BRAFV600-mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

Excerpt:
...Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Vemurafenib and Cobimetinib Combination in BRAF Mutated Melanoma With Brain Metastasis

Excerpt:
...Documented BRAFV600 mutation determined in a hospital center specializing in the molecular genetics of cancer that is certified by the French national cancer institute (INCa)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

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

Excerpt:
...- Melanoma must be documented to contain a BRAFV600 mutation by a FDA approved assay...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib

Excerpt:
...Any patient with metastatic melanoma (any site) whose tumor is V600EBRAF positive, regardless of prior treatment....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

ML29255 Neoadjuvant Vemurafenib and Cobimetinib Melanoma

Excerpt:
...- Melanoma must be documented to contain a BRAFV600 mutation by a CLIA approved laboratory...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A phase II trial of vemurafenib plus cobimetinib in patients treated with prior first-line systemic immunotherapy for inoperable locally advanced or metastatic melanoma Uno studio clinico di fase II sull'associazione di vemurafenib e cobimetinib nei pazienti gi¿ trattati in prima linea con immunoterapia sistemica per melanoma inoperabile localmente avanzato o metastatico

Excerpt:
...3) Adjuvant treatment is allowed, except for anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 agents4) Patients must be naïve to treatment for locally advanced unresectable or metastatic with BRAF/MEK inhibitors5) Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue BRAF V600 mutation test6) At least one measurable lesion according to disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria7) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0- 28) Male or female patient aged = 18 years9) Able to participate and willing to give written informed consent prior to performance of any study-related procedures and to comply with the study protocol10) Life expectancy = 12 weeks 1) Pazienti con melanoma metastatico di stadio IIIc o IV non resecabile confermato istologicamente secondo la definizione dell'American Joint Committee on Cancer 7ma edizione. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
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:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Effectiveness, safety and utilization of cobimetinib and vemurafenib in patients with BRAF V600 mutant melanoma with and without cerebral metastasis under real-world conditions in Germany: the non-interventional study coveNIS

Published date:
11/13/2023
Excerpt:
Median OS was 21.6 months in Cohort A, 7.4 months in Cohort B. Median PFS was 6.9 months in Cohort A, 5.2 months in Cohort B….The aim of the present study was, therefore, to collect real-world data on effectiveness of cobimetinib/vemurafenib with a special focus on OS, safety and utilization of the combination therapy in two separate cohorts: patients with unresectable or metastatic BRAF V600 mutated mM without cerebral metastases and patients with metastatic BRAF V600 mutated mM with cerebral metastases.
DOI:
10.1097/CMR.0000000000000908
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A pilot study of the neoadjuvant use of vemurafenib plus cobimetinib in patients with BRAF-mutant melanoma with palpable lymph node metastases: Survival results.

Published date:
05/25/2023
Excerpt:
This was a single arm, prospective, multi centre phase II study in patients with histologically confirmed, BRAF V600 mutated Stage IIIB and IIIC melanoma (AJCC 7th Edition) with palpable nodal disease. Patients received vemurafenib 960mg PO BID and cobimetinib 60mg PO OD for 4 months prior to resection followed by 8 months of adjuvant therapy post-surgery....At 60 months, LRFS was 89.5% (76.7-100%), DMFS was 75.0% (59.5-94.5%), DFS was 85.7% (72.0-100%), and OS was 63.9% (95% CI 43.5-93.8). Among total 20 evaluable patients, 17 patients had CR/PR and 3 had PD/SD as best response.
DOI:
10.1200/JCO.2023.41.16_suppl.9579
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

799P - A pilot study of the neo-adjuvant use of vemurafenib plus cobimetinib in patients with BRAF mutant melanoma with palpable lymph node metastases

Published date:
09/05/2022
Excerpt:
This was a single arm, prospective, multi centre phase II study in patients with confirmed BRAF V600 mutated Stage IIIB and IIIC melanoma…Neoadjuvant vemurafenib and cobimetinib led to all patients being resectable with a high response rate, pathologic response rate and low local recurrence rate in melanoma patients with palpable lymph nodes.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice

Published date:
11/27/2021
Excerpt:
Retrospective, observational, cross-sectional, multicenter study involving 41 patients with advanced melanoma harboring a BRAF V600 mutation who initiated a combination therapy with vemurafenib/cobimetinib...During the combination therapy, 12 patients (29.3%) had a CR, 19 a PR (46.3%), 5 showed SD (12.2%), and 5 had PD. A total of 12 patients (29.3%) were considered as achieving a durable response and 29 (70.7%) as a non-durable one.
DOI:
https://doi.org/10.2147/OTT.S325208
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice

Published date:
11/27/2021
Excerpt:
Retrospective, observational, cross-sectional, multicenter study involving 41 patients with advanced melanoma harboring a BRAF V600 mutation who initiated a combination therapy with vemurafenib/cobimetinib... During the combination therapy, 12 patients (29.3%) had a CR, 19 a PR (46.3%), 5 showed SD (12.2%), and 5 had PD....The combination treatment with vemurafenib/cobimetinib results in an important impact on long-term survival, leading to a steady CR in one-third of the patients.
DOI:
10.2147/OTT.S325208
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Observational cross-sectional study evaluating the sociodemographic and clinical characteristics of patients with metastatic melanoma harboring a BRAF V600 mutation, treated with cobimetinib and vemurafenib based on routine clinical practice.

Published date:
05/28/2020
Excerpt:
Participants were patients with advanced melanoma harboring a BRAF V600 mutation, who received Cobimetinib + Vemurafenib as first line, and who started treatment at least 12 months before inclusion....CR was the best response achieved by 29.3% of patients, 46.3% achieved PR and 12.2% SD (stable disease). Mean of time to response was 6.9 months for CR patient, and 3.3 and 2.2 months for PR and SD patients respectively. Mean of duration of response was 9.4 months for CR patients, and 10.1 and 9.5 months for PR and SD patients respectively....Vemurafenib and Cobimetinib have an important impact in long term survival, leading to a steady complete response in one third of the patients.
DOI:
10.1200/JCO.2020.38.15_suppl.e22028
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Combination of vemurafenib and cobimetinib in patients with advanced BRAFV600-mutated melanoma: a phase 1b study

Excerpt:
...a phase 1b study in patients with advanced BRAF(V600)-mutated melanoma...patients received vemurafenib 720 mg or 960 mg twice a day continuously and cobimetinib 60 mg, 80 mg, or 100 mg once a day for either 14 days on and 14 days off (14/14), 21 days on and 7 days off (21/7), or continuously (28/0)....Confirmed objective responses were recorded in ten (15%) of 66 patients who had recently progressed on vemurafenib, with a median progression-free survival of 2·8 months (95% CI 2·6-3·4). Confirmed objective responses were noted in 55 (87%) of 63 patients who had never received a BRAF inhibitor, including six (10%) who had a complete response; median progression free survival was 13·7 months (95% CI 10·1 17·5)....The combination has promising antitumour activity and further clinical development is warranted in patients with advanced BRAF(V600)-mutated melanoma...
DOI:
https://doi.org/10.1016/S1470-2045(14)70301-8
Trial ID: