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Association details:
Biomarker:BRAF V600
Cancer:Melanoma
Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Excerpt:
KEYTRUDA is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Secondary therapy:
BRAF inhibitor
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Ph 1/2 Substudy of 1L Oncological Treatment(s) in Advanced MEL

Excerpt:
...4.Has been untreated for advanced disease except as follows: a.BRAF V600 mutation-positive melanoma may have received SOC targeted therapy as 1L therapy for advanced disease (eg, BRAF/MEK inhibitor, alone or in combination). ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma

Excerpt:
...Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status ; 7....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A single arm trial evaluating the efficacy and safety of EVX-01 in combination with pembrolizumab in adults with unresectable or metastatic melanoma Studio a braccio singolo volto a valutare l’efficacia e la sicurezza di EVX-01 in combinazione con pembrolizumab in adulti affetti da melanoma non resecabile o metastatico

Excerpt:
...Patientswith BRAF V600E mutant melanoma may have received prior BRAFinhibitor therapy as first-line systemic therapy and be eligible for this trial assecond line treatment. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer

Excerpt:
...BRAF V600 mutation patients must have progressed on, or are intolerant to, BRAF +/- MEK inhibitor therapy....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer

Excerpt:
...Irrespective of PD-L1 result and BRAF V600 mutation 4....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)

Excerpt:
...BRAF V600 mutant melanoma may have received standard of care targeted therapy (e.g....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer

Excerpt:
...- Unresectable or metastatic disease progression following a BRAF inhibitor if BRAF V600 positive -...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma

Excerpt:
...Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic melanoma with BRAF V600E/K mutation will be enrolled in this study....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

Excerpt:
...- Documentation of V600E-activating BRAF mutation status....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer

Excerpt:
...If the melanoma expresses a BRAF mutation of V600E, V600K, or V600R patient must have received and progressed through a BRAF inhibitor or have failed that therapy due to toxicity....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study Comparing Pembrolizumab With Dual MAPK Pathway Inhibition Plus Pembrolizumab in Melanoma Patients

Excerpt:
...- Histologically/cytologically confirmed stage IV BRAF V600E or K metastatic melanoma...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase 3 Study of Epacadostat and Pembrolizumab in Melanoma

Excerpt:
...BRAF V600 mutant melanoma may have received standard of care targeted therapy (e.g. BRAF/MEK inhibitor, alone or in combination) and be eligible for this study Note: Targeted therapy is not required for eligibility. ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

First-line pembrolizumab versus dabrafenib/trametinib treatment for BRAF V600-mutant advanced melanoma

Published date:
09/03/2022
Excerpt:
To investigate the outcomes associated with first-line pembrolizumab or dabrafenib/trametinib treatment for advanced melanoma with activating BRAF V600 mutation….Pembrolizumab may be recommended over BRAF/mitogen-activated protein kinase kinase inhibitors as the first-line treatment in patients with advanced BRAF V600-mutant melanoma.
DOI:
10.1016/j.jaad.2022.07.057