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Association details:
Biomarker:BRAF mutation
Cancer:Melanoma
Drug:Opdivo (nivolumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

INDUCING REMISSION IN MELANOMA PATIENTS WITH CHECKPOINT INHIBITOR THERAPY USING FECAL MICROBIOTA TRANSPLANTATION.

Excerpt:
...a) Patients with histologically confirmed malignant melanoma- Age > 18 years- Written consent of the participant after being informed- Contraception as described in protocol appendix section VIb) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): PS 0 to 1.c) Previously treated, unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2017 Guidelines (8th Edition) regardless of BRAF mutation status.d) Patients must have experienced disease progression or recurrence during treatment with an anti-PD-1 monoclonal antibody. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications

Excerpt:
...BRAF (V600) mutation status must be known....
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A first-in-human clinical trial in adult patients with metastatic or recurrent melanoma of a personalised therapy targeting specific mutations that occur in all cancer cells within a single patient. Primer estudio en humanos en pacientes adultos con melanoma metastásico o recurrente, para la evaluación de una terapia personalizada que se dirige a mutaciones específicas que ocurren en todas las células de cáncer de un único paciente

Excerpt:
...Patients whose tumour is known to have a BRAF V600 mutation must have received BRAF targeted therapy (as well as a PD-1/PD-L1 inhibitor unless contraindicated) prior to treatment with ATL001.6. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A study in patients with skin cancer

Excerpt:
...Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before randomization. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma

Excerpt:
...- At least 1 PD-1 targeted immunotherapy and BRAF inhibition in case of BRAF mutated melanoma...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Nivolumab Plus Radiotherapy in Advanced Melanoma

Excerpt:
...BRAF status must be determinate but patient will be eligible regardless the status (BRAF wildtype and BRAF V600 mutation positive patients could be included) 9....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

Excerpt:
...- Known BRAF wild-type, as per regionally acceptable V600 mutational status testing....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Combined Therapy of Nivolumab and Adoptive T Cell Therapy in Metastatic Melanoma Patients

Excerpt:
...- Patients with a melanoma expressing a Braf V600 mutation can be included...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC

Excerpt:
...Subjects with a documented B-Raf (BRAF) mutation must have received the appropriate targeted therapy For MSI-H/dMMR patients -Histologically confirmed MSI-H/d...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

Excerpt:
...- Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors

Excerpt:
......
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-world treatment patterns and overall survival in BRAF-mutant melanoma patients treated with immunotherapy or targeted therapy

Published date:
04/20/2022
Excerpt:
Advanced BRAF-mutant melanoma patients treated with 1L CPI or TT were selected from a real-world, electronic health record-derived database....CPI was associated with improved survival after adjustment for potential confounders (hazard ratio, 0.75 [95% CI, 0.66–0.87])....This real-world study demonstrated a survival benefit with 1L CPI versus TT.
DOI:
10.2217/fon-2021-1536
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1074P-Italian nivolumab Expanded Access Program (EAP) in melanoma adjuvant setting: Patients outcomes and safety profile

Published date:
09/13/2021
Excerpt:
From November 2018 to June 2019 we enrolled 612 patients (pts) with stage III and IV resected melanoma to receive nivolumab…BRAF MUT...RFS 12mos-18mos (%)...83-74...RFS in BRAF mutated pts was higher than that of CM238…