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DRUG CLASS:

cRAF inhibitor

2d
BEAVER: Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations (clinicaltrials.gov)
P2, N=26, Active, not recruiting, University Health Network, Toronto | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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BRAF (B-raf proto-oncogene) • KIAA1549
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BRAF mutation • BRAF V600K • BRAF fusion
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Mektovi (binimetinib) • Braftovi (encorafenib)
5d
Trial completion date
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BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600 • BRAF V600K
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Keytruda (pembrolizumab) • Mektovi (binimetinib) • Braftovi (encorafenib)
6d
Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory (clinicaltrials.gov)
P2, N=7, Active, not recruiting, Northwestern University | Recruiting --> Active, not recruiting | N=43 --> 7 | Trial primary completion date: Jul 2028 --> May 2026
Enrollment closed • Enrollment change • Trial primary completion date
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BRAF V600E • BRAF V600
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Erbitux (cetuximab) • Vectibix (panitumumab) • Braftovi (encorafenib) • hydroxychloroquine
7d
S2107: Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation (clinicaltrials.gov)
P2, N=86, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Sep 2026 --> Feb 2026
Trial completion date • Trial primary completion date
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BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
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BRAF V600E • BRAF V600
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Opdivo (nivolumab) • Erbitux (cetuximab) • Braftovi (encorafenib) • ABP 206 (nivolumab biosimilar)
9d
DosinTACE: Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=48, Active, not recruiting, Nanfang Hospital, Southern Medical University | Not yet recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Mar 2026
Enrollment closed • Trial primary completion date
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Tyvyt (sintilimab) • Zepsun (donafenib)
15d
Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory (clinicaltrials.gov)
P2, N=43, Recruiting, Northwestern University | Trial completion date: Jul 2028 --> Jul 2030 | Trial primary completion date: Jul 2026 --> Jul 2028
Trial completion date • Trial primary completion date
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BRAF V600E • BRAF V600
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Erbitux (cetuximab) • Vectibix (panitumumab) • Braftovi (encorafenib) • hydroxychloroquine
28d
The DoHAICs Study Expansion Phase (clinicaltrials.gov)
P2, N=90, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
New P2 trial
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Tyvyt (sintilimab) • oxaliplatin • Zepsun (donafenib)
1m
Trial suspension
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BRAF (B-raf proto-oncogene)
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BRAF V600E
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Erbitux (cetuximab) • Braftovi (encorafenib) • ZEN-3694
1m
Prolonged response to Pembrolizumab in BRAFV600E microsatellite stable metastatic colorectal cancer following an increase in tumour mutational burden. (PubMed, Oncologist)
Outcomes following progression on chemotherapy and MAPK-targeted therapy with Encorafenib plus Cetuximab remain poor, highlighting an unmet need for effective later-line treatments. We discuss the mechanistic framework by which a subset of BRAFV600E-mutant MSS mCRC may respond to immune checkpoint inhibition through an inflamed immune microenvironment driven by constitutive MAPK signalling. This case illustrates the interplay between tumour-agnostic biomarkers such as TMB-high and tumour-specific context, and highlights the value of longitudinal genomic profiling, including ctDNA, to identify resistance mechanisms and guide treatment selection.
Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1)
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BRAF V600E • TMB-H • BRAF V600
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Keytruda (pembrolizumab) • Erbitux (cetuximab) • Braftovi (encorafenib)
1m
Efficacy and safety of transarterial chemoembolization plus donafenib with or without camrelizumab for unresectable hepatocellular carcinoma: a propensity score matching analysis. (PubMed, Front Immunol)
Although the TACE+D+C group exhibited immune-related adverse events (irAEs) (e.g., hypothyroidism and reactive cutaneous capillary endothelial proliferation), no significant differences were observed between the two groups in drug-related TRAEs, TRAEs after TACE, or Grade 3 TRAEs. The TACE+D+C group significantly improves ORR, PFS and OS in uHCC patients with a comparable safety profile to the TACE+D group, while the single-center retrospective design limits generalizability, warranting prospective studies.
Retrospective data • Journal
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AFP (Alpha-fetoprotein)
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AiRuiKa (camrelizumab) • Zepsun (donafenib)
1m
A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors (clinicaltrials.gov)
P1/2, N=15, Terminated, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | N=42 --> 15 | Recruiting --> Terminated; Due to R&D strategy adjustments; no safety issues involved.
Enrollment change • Trial termination
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erfonrilimab (KN046) • Zepsun (donafenib)