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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Combination dabrafenib and trametinib versus combination nivolumab and ipilimumab for patients with advanced BRAF-mutant melanoma: The DREAMseq Trial - ECOG-ACRIN EA6134

Published date:
09/27/2022
Excerpt:
In a phase III trial, patients with treatment-naïve BRAFV600-mutant metastatic melanoma were randomized to receive either combination nivolumab/ipilimumab (Arm A) or dabrafenib/trametinib (Arm B)…Median duration of response was not reached for Arm A and 12.7 months for Arm B (p<0.001)....Combination nivolumab/ipilimumab followed by BRAF and MEK inhibitor therapy, if necessary, should be the preferred treatment sequence for a large majority of patients.
DOI:
10.1200/JCO.22.01763
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Real-world survival of patients with advanced BRAF V600 mutated melanoma treated with front-line BRAF/MEK inhibitors, anti-PD-1 antibodies, or nivolumab/ipilimumab

Published date:
11/02/2019
Excerpt:
...2283 patients’ melanomas harbored a documented BRAF V600 mutation...Two hundred and ninety seven were found to have received treatment with front‐line BRAF/MEKi (n = 35 vemurafenib/cobimetinib, n = 262 dabrafenib/trametinib), while 162 patients received treatment with front‐line aPD‐1 (n = 69 nivolumab, n = 93 pembrolizumab), and 108 patients received treatment with front‐line niv/ipi....In our real-world retrospective analysis, patients with advanced BRAF mutant melanoma treated with front-line niv/ipi or aPD-1 had longer survival compared to those treated with front-line BRAF/MEKi.
DOI:
10.1002/cam4.2625
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma

Excerpt:
Any patient with BRAF V600 mutant melanoma (whether cutaneous, acral or mucosal primary) who meets the eligibility criteria is eligible for participation in this trial...Patients must have BRAF V600 mutation, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Act (CLIA)-certified lab; if test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test, Foundation Medicine).
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma (CheckMate 069)

Excerpt:
Known BRAF V600 mutation status as determined by an FDA-approved test. Patients with either V600 wild-type or V600 mutation-positive melanoma are eligible.
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Systemic therapy for Asian patients with advanced BRAF V600-mutant melanoma in a real-world setting: A multi-center retrospective study in Japan (B-CHECK-RWD study)

Published date:
08/16/2023
Excerpt:
We retrospectively collected data of Asian patients with advanced BRAF V600-mutant melanoma treated with first-line BRAF/MEK inhibitors (BRAF/MEKi), anti-PD-1 monotherapy (Anti-PD-1), and nivolumab plus ipilimumab (PD-1/CTLA-4)...For patients treated with BRAF/MEKi, anti-PD-1, PD-1/CTLA-4, the median ages at baseline were 62, 62, and 53 years (p = 0.03); objective response rates were 69%, 27%, and 28% (p < 0.001); median progression-free survival (PFS) was 14.7, 5.4, and 5.8 months (p = 0.003)...
DOI:
10.1002/cam4.6438
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Second line ipilimumab-nivolumab for melanoma brain metastases following progression on BRAFMEK inhibitors

Excerpt:
IRR and PFS to 2-3L I-N in BRAFm MBM was poor highlighting the potential benefit of 1L I-N in this group.
Evidence Level:
Sensitive: C4 – Case Studies
Source:
Title:

Monitoring response to therapy in melanoma by quantifying circulating tumour DNA with droplet digital PCR for BRAF and NRAS mutations

Excerpt:
Patient 5 (V600EBRAF) presented with extensive metastatic disease and was enrolled in the CheckMate 067 trial (anti-PD-1 antibody nivolumab alone versus anti-CTLA-4 antibody ipilimumab alone versus combination of the two)...Follow up CT scans also demonstrated tumour shrinkage (Fig. 3a). The PET scan performed on day 188 showed no metabolically active lesions and the tumour seen on CT scans from day 1 of treatment (Fig. 3b red arrow) was resolved on day 263 (Fig 3c).
DOI:
10.1038/srep11198