Melanoma - pembrolizumab - BRAF mutation

Association details:

Biomarker:	BRAF mutation
Cancer:	Melanoma
Drug:	Keytruda (pembrolizumab) (PD1 inhibitor)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

Title:

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD1 or AntiPDL1 Antibodies

Excerpt:

...For subjects with a known BRAF V600-activating mutation combination targeted therapy will be required in addition to anti-PD-1/PD-L1 therapy.3. ...

Trial ID:

2019-001923-11

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

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:

KEYNOTE-555

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

Excerpt:

...Melanoma with known BRAFv600 mutation: received BRAF/MEKi therapy before this study....

Trial ID:

KEYNOTE-F62

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

NovoTTF-200A + Pembrolizumab In Melanoma Brain Metastasis

Excerpt:

...Both BRAF wild-type and mutated melanomas are eligible; BRAF mutated patients are required to have previously progressed on or...

Trial ID:

NCT04129515

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers

Excerpt:

...Have received a combination of a BRAF inhibitor and a MEK inhibitor if diagnosed with a BRAF mutated melanoma and if clinically indicated; and 5....

Trial ID:

Catalyst

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

CyPep-1 Injections in Cancer Inducing Lymphocyte Infiltrate Accumulations

Excerpt:

......

Trial ID:

CICILIA

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Safety and Efficacy Study of Pembrolizumab (MK-3475) in Chinese Participants With Locally Advanced or Metastatic Melanoma (MK-3475-151/KEYNOTE-151)

Excerpt:

...- Has documented BRAF mutation status or is willing to provide a tumor tissue for BRAF genotyping....

Trial ID:

Keynote-151

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

IMM60 and Pembrolizumab in Melanoma and NSCLC

Excerpt:

...B-type Raf proto-oncogene (BRAF) mutation status available -...

Trial ID:

KEYNOTE-E69

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

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:

NCT05620134

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

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:

NEO-MIMAJOR

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)

Excerpt:

...- Has testing for a BRAF mutation prior to study entry...

Trial ID:

KEYNOTE-161

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

Excerpt:

...- Participants with BRAF gene mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF gene and/or mitogen-activated protein kinase (MEK) protein inhibitor...

Trial ID:

KEYNOTE 002

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

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:

NCT05877430

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

Title:

Phase II study of pembrolizumab combined with temozolomide as first-line treatment in Chinese patients with metastatic acral melanoma

Excerpt:

...BRAF wild-type, or mutant subjects who were intolerant or failed standard targeted drug therapy....

Trial ID:

ChiCTR2100050073

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

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). ...

Trial ID:

2019-003977-24

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Future Oncol

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