BRAF V600E — biomarker · CancerIndex

Biomarker · Gene alteration

BRAF V600E

BRAF codon 600 point mutation p.V600E detected by sequencing, PCR or mutation-specific immunohistochemistry; used as a predictive marker for BRAF/MEK inhibitor therapy across melanoma, thyroid, colorectal, lung and other cancers.

CI-BIO-00000018BRAF graph →NCIt C98342 Tumor-agnostic · 4 approval rows

Also calledp.V600E · BRAF V600E-mutant · c.1799T>A

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (4)

Dabrafenib US FDA · Mar 16, 2023 · drug + indication textRegulatory approved
Dabrafenib US FDA · May 29, 2013 · drug + indication textRegulatory approved
Trametinib US FDA · Mar 16, 2023 · drug + indication textRegulatory approved
Trametinib US FDA · May 29, 2013 · drug + indication textRegulatory approved

The flag is the source's (openFDA label text), never inferred; the full indication text of each row is in the Approvals section below.

Derived

Associated cancers (24)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Malignant Colorectal Neoplasm	37	31	6	—	1 / 21 / 6 / 8 / 1
Melanoma	31	29	2	—	0 / 19 / 2 / 10 / 0
Thyroid Gland Papillary Carcinoma	12	3	8

Derived

Drugs with predictive evidence (29)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
VemurafenibSmall Molecule	45	36	9	A	34 / 9	Childhood Pilocytic Astrocytoma, Cholangiocarcinoma, Cutaneous Melanoma, Digestive System Neuroendocrine Tumor +12
DabrafenibSmall Molecule	22	19	3	A	18 / 4	Cholangiocarcinoma, Cutaneous Melanoma, Digestive System Neuroendocrine Tumor, Intrahepatic Cholangiocarcinoma +8
TrametinibSmall Molecule	20	19	1	A	18 / 0	Cholangiocarcinoma, Cutaneous Melanoma, Digestive System Neuroendocrine Tumor, Intrahepatic Cholangiocarcinoma +8
CetuximabMonoclonal Antibody	12	6	6	A	6 / 5	Malignant Colorectal Neoplasm
PanitumumabMonoclonal Antibody	9	6	3	B	4 / 2	Cholangiocarcinoma, Malignant Colorectal Neoplasm
IrinotecanSmall Molecule	6	3	3	B	3 / 3	Cholangiocarcinoma, Malignant Colorectal Neoplasm
SelumetinibSmall Molecule	4	3	1	B	1 / 1	Malignant Colorectal Neoplasm, Malignant Neoplasm, Melanoma
CobimetinibSmall Molecule	3	3	—	B	3 / 0	Malignant Colorectal Neoplasm, Malignant Neoplasm, Melanoma
EncorafenibSmall Molecule	3	3	—	A	3 / 0	Malignant Colorectal Neoplasm
BevacizumabMonoclonal Antibody	2	1	1	B	1 / 1	Malignant Colorectal Neoplasm
BinimetinibSmall Molecule	2	2	—	B	2 / 0	Malignant Colorectal Neoplasm
CapecitabineSmall Molecule	2	1	1	B	1 / 1	Malignant Colorectal Neoplasm
DactolisibSmall Molecule	2	2	—	D	2 / 0	Malignant Colorectal Neoplasm, Melanoma
OxaliplatinSmall Molecule	2	—	2	B	0 / 2	Malignant Colorectal Neoplasm
PLX4720	2	2	—	D	2 / 0	Malignant Colorectal Neoplasm, Melanoma
UprosertibSmall Molecule	2	2	—	D	2 / 0	Melanoma
ErlotinibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
FOLFOX-4 Regimen	1	—	1	B	0 / 1	Malignant Colorectal Neoplasm
GDC-0879Small Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
GefitinibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
JQEZ5	1	1	—	D	1 / 0	Melanoma
Nutlin-3Small Molecule	1	1	—	D	1 / 0	Melanoma
PertuzumabMonoclonal Antibody	1	1	—	C	1 / 0	Thyroid Gland Anaplastic Carcinoma
PictilisibSmall Molecule	1	1	—	C	1 / 0	Melanoma
Pictilisib Bismesylate	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
SorafenibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
TovorafenibSmall Molecule	1	1	—	A	1 / 0	Childhood Low Grade Glioma
MEK Inhibitor RO4987655	1	—	1	B	—	Melanoma
MirdametinibSmall Molecule	1	—	1	D	—	Melanoma

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (92)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–50 of 92 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
BRAF V600E + BRAF Fusion1
Tovorafenib	Childhood Low Grade Glioma	Predictive	A	Supports Sensitivity Response	5	accepted	EID12016 In this ongoing phase 2 trial (FIREFLY-1), 76 patients, aged 6 months to 25 years, with pediatric low-grade glioma harbouring BRAF alterations (BRAF fusions or BRAF V600E mutations) were treated with … (full text at CIViC) PMID 37978284 · Kilburn et al., 2024 · Open in CIViC	civic
BRAF V600E45
Vemurafenib	Childhood Pilocytic Astrocytoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID3777 In a case report, a 28 month old patient with a cervicomedullary low grade glioma compatible with pilocytic astrocytoma which was resected had a second lesion consistent with a ganglioglioma 3 years l… (full text at CIViC) PMID 25524464 · del Bufalo et al., 2014 · Open in CIViC	civic
Dabrafenib + TrametinibCombination	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID5902 Chemotherapy-refractory, metastatic cholangiocarcinoma with CNS involvement and a BRAF V600E mutation had a partial response at 8 weeks to dabrafenib and trametinib combination with complete radiologi… (full text at CIViC) PMID 28480077 · Kocsis et al., 2017 · Open in CIViC	civic
Irinotecan + Panitumumab + VemurafenibCombination	Cholangiocarcinoma
BRAF K601E + BRAF V600E1
Cobimetinib + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID11670 This clinical study was conducted with 30 patients with colorectal cancer harboring BRAF V600E (n = 29) or BRAF K601E (n=1) mutations, treated with a combination of cobimetinib and vemurafenib. Of the… (full text at CIViC) PMID 36409971 · Klute et al., 2022 · Open in CIViC	civic
BRAF Amplification + BRAF V600E1
Selumetinib	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	E	Supports Resistance	4	accepted	EID92 COLO201 and COLO206F cells harboring BRAF V600E mutations were cloned to be MEK inhibitor (AZD6244 [selumetinib]) resistant. The mechanism of this resistance was shown to be amplification of the BRAF … (full text at CIViC) PMID 21098728 · Corcoran et al., 2010 · Open in CIViC	civic
ARAF S490T + BRAF V600EBRAF ARAF1
Cetuximab + Irinotecan + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	1	accepted	EID1905 Phase 1b study of vemurafenib, cetuximab and irinotecan in 19 BRAF V600E mutant colorectal cancer patients. cfDNA panel sequencing was performed in 10 patients after disease progression. One patient h… (full text at CIViC) PMID 27729313 · Hong et al., 2016 · Open in CIViC	civic
BRAF V600E + GNAS R201CBRAF GNAS1
Cetuximab + Irinotecan + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID1906 Phase 1b study of vemurafenib, cetuximab and irinotecan in 19 BRAF V600E mutant colorectal cancer patients. cfDNA panel sequencing was performed in 10 patients after disease progression. One patient a… (full text at CIViC) PMID 27729313 · Hong et al., 2016 · Open in CIViC	civic

Regulatory

Approvals mentioning the linked drugs (364)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

openfdaRegulatory50 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Dabrafenib	US FDA	Tumor-agnostic	the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. • TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 )accelerated	approved	Mar 16, 2023	openfda
Dabrafenib	US FDA	Tumor-agnostic	the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. • TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 )accelerated	approved

1 record matched on indication text only (drug not in the derived set). Health Canada DIN rows carry no indication text and only match by drug.

Clinical trials

Active trials (473)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 247 recruiting · 84 active phase 3 · 2,296 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 401–450 of 473 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03390686	A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients	active not recruiting	Phase 3	650	Prestige Biopharma LimitedINDUSTRY	17	May 31, 2025	clinicaltrials
NCT04861558	Efficacy of Hyperthermic Intraperitoneal Chemotherapy(EFFIPEC)	recruiting	Phase 3	213	Uppsala UniversityOTHER	2	May 30, 2025	clinicaltrials
NCT04043195	Nivolumab and Ipilimumab in Combination With Immunogenic Chemotherapy for Patients With Advanced NSCLC(NSCLC)	active not recruiting	Phase 1 / Phase 2	30	Hatim HusainOTHER	1	May 28, 2025	clinicaltrials
NCT05312398	CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen	active not recruiting	Phase 2	219	University of Campania Luigi VanvitelliOTHER	1	May 25, 2025	clinicaltrials
NCT06990516	SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer	not yet recruiting	Phase 1 / Phase 2	90	Tongji HospitalOTHER	1	May 25, 2025	clinicaltrials
NCT04941287	Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer	active not recruiting	Phase 2	57	National Cancer Institute (NCI)NIH	1	May 23, 2025	clinicaltrials
NCT06381570	Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas(VICTORY)	recruiting	Early Phase 1	57	Daniel MorgensternOTHER	1	May 15, 2025	clinicaltrials
NCT06963502	A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors	not yet recruiting	Phase 1	762	Jiangsu Hansoh Pharmaceutical Co., Ltd.INDUSTRY	1	May 9, 2025	clinicaltrials
NCT06090994	Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy	recruiting	Phase 4	756	Fudan UniversityOTHER	1	May 7, 2025	clinicaltrials
NCT05342194	Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study	recruiting	Phase 3	480	Shanghai Junshi Bioscience Co., Ltd.OTHER	1	Apr 23, 2025	clinicaltrials
NCT06895928	A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors	recruiting	Phase 2	400	Shanghai Hengrui Pharmaceutical Co., Ltd.INDUSTRY	1	Apr 22, 2025	clinicaltrials
NCT04775485	A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors(FIREFLY-1)	recruiting	Phase 2	141	Day One Biopharmaceuticals, Inc.INDUSTRY	11	Apr 10, 2025	clinicaltrials
NCT05275374	XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation(ENHANCE)	not yet recruiting	Phase 1 / Phase 2	221	Xynomic Pharmaceuticals, Inc.INDUSTRY	0	Apr 10, 2025	clinicaltrials
NCT02170090	Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer(ACTICCA-1)	active not recruiting	Phase 3	789	Universitätsklinikum Hamburg-EppendorfOTHER	8	Mar 30, 2025	clinicaltrials
NCT06888843	Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in Elderly Patients as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer.(AHTCRR-1)	recruiting	Phase 2	160	Nizhny Novgorod Regional Clinical Oncology CenterOTHER_GOV	1	Mar 27, 2025	clinicaltrials
NCT05828459	First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors	recruiting	Phase 1	150	Onward TherapeuticsINDUSTRY	1	Mar 20, 2025	clinicaltrials
NCT06856447	The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer	recruiting	Phase 1	22	toqa saad mohammed mohammedOTHER	1	Mar 4, 2025	clinicaltrials
NCT06208462	Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors	recruiting	Phase 2	33	The First Affiliated Hospital with Nanjing Medical UniversityOTHER	1	Mar 3, 2025	clinicaltrials
NCT06849362	Multicenter Retrospective Study on Optimizing Combination Immunotherapy Strategies in MSS/MSI-L/pMMR Advanced Colorectal Cancer	enrolling by invitation	—	200	Yue GouOTHER	1	Feb 27, 2025	clinicaltrials
NCT06825624	ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer	recruiting	Phase 1	560	Hansoh BioMedical R&D CompanyINDUSTRY	1	Feb 13, 2025	clinicaltrials
NCT05200260	Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer	recruiting	Phase 2	220	Shanghai Gynecologic Oncology GroupOTHER_GOV	1	Feb 10, 2025	clinicaltrials
NCT03944772	Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)(ORCHARD)	active not recruiting	Phase 2	247	AstraZenecaINDUSTRY	9	Jan 30, 2025	clinicaltrials
NCT05504278	Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation	recruiting	Phase 1	144	Innovent Biologics (Suzhou) Co. Ltd.INDUSTRY	1	Jan 27, 2025	clinicaltrials
NCT06607276	Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE(ACHIEVE)	recruiting	Phase 2	122	The First Affiliated Hospital with Nanjing Medical UniversityOTHER	1	Jan 16, 2025	clinicaltrials
NCT06775275	A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC	recruiting	Phase 2	60	The First Affiliated Hospital of Guangzhou Medical UniversityOTHER	1	Jan 15, 2025	clinicaltrials
NCT03709680	Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors	active not recruiting	Phase 2	128	PfizerINDUSTRY	14	Jan 14, 2025	clinicaltrials
NCT04295317	PD-1 Antibody (SHR-1210) Plus Capecitabine in Patients with Intrahepatic Cholangiocarcinoma After Surgery	active not recruiting	Phase 2	65	Shanghai Zhongshan HospitalOTHER	1	Jan 3, 2025	clinicaltrials
NCT05462613	Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer(REPROGRAM-02)	recruiting	Phase 2 / Phase 3	446	Centre Hospitalier Universitaire de BesanconOTHER	1	Dec 20, 2024	clinicaltrials
NCT06739395	Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion	recruiting	Phase 2	300	Tianjin Medical University Second HospitalOTHER	1	Dec 18, 2024	clinicaltrials
NCT06735326	Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer	recruiting	Phase 2	105	Qilu Hospital of Shandong UniversityOTHER	1	Dec 16, 2024	clinicaltrials
NCT05824975	A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)	recruiting	Phase 1 / Phase 2	358	GI Innovation, Inc.INDUSTRY	2	Nov 25, 2024	clinicaltrials
NCT04294264	TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer	active not recruiting	Phase 2	50	Rutgers, The State University of New JerseyOTHER	1	Nov 18, 2024	clinicaltrials
NCT06411600	Combination Therapy for BRAF-V600E Metastatic CRCm(BRAVE)	recruiting	Phase 2	94	Vall d'Hebron Institute of OncologyOTHER	1	Nov 8, 2024	clinicaltrials
NCT05468242	Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy	recruiting	Phase 2	116	Sun Yat-sen UniversityOTHER	1	Oct 30, 2024	clinicaltrials
NCT06650709	NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study(NEOCATS)	not yet recruiting	Phase 2	40	British Columbia Cancer AgencyOTHER	0	Oct 23, 2024	clinicaltrials
NCT03635021	Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer(CR-SEQUENCE)	active not recruiting	Phase 3	419	Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)OTHER	1	Oct 21, 2024	clinicaltrials
NCT04547166	A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)	recruiting	Phase 2 / Phase 3	568	Shanghai Henlius BiotechINDUSTRY	2	Oct 17, 2024	clinicaltrials
NCT06184698	Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer	recruiting	Phase 2	173	Hebei Medical University Fourth HospitalOTHER	1	Oct 9, 2024	clinicaltrials
NCT04117945	Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer	active not recruiting	Phase 2	22	Academic and Community Cancer Research UnitedOTHER	1	Sep 27, 2024	clinicaltrials
NCT06493760	A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients	recruiting	Phase 2	130	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.INDUSTRY	1	Sep 19, 2024	clinicaltrials
NCT06540261	The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer	active not recruiting	Phase 1	65	Ono Pharmaceutical Co., Ltd.INDUSTRY	1	Sep 19, 2024	clinicaltrials
NCT05654454	A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer	recruiting	Phase 3	620	Mabscale, LLCINDUSTRY	1	Aug 16, 2024	clinicaltrials
NCT06557096	CSF CTC-Capture-Guided EGFR-TKI and Bevacizumab Combination Therapy in EGFR-Mutant Advanced NSCLC	not yet recruiting	Early Phase 1	100	Second Affiliated Hospital of Nanchang UniversityOTHER	0	Aug 16, 2024	clinicaltrials
NCT06341296	Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer	recruiting	Phase 2	86	West China HospitalOTHER	1	Aug 12, 2024	clinicaltrials
NCT06532149	ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer(EROS)	recruiting	—	80	Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER	1	Aug 9, 2024	clinicaltrials
NCT06547385	Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer	active not recruiting	Phase 1	40	Ono Pharmaceutical Co., Ltd.INDUSTRY	1	Aug 9, 2024	clinicaltrials
NCT06509126	Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer(IMPROVE-2)	recruiting	Phase 3	500	National Cancer Institute, NaplesOTHER	1	Jul 19, 2024	clinicaltrials
NCT06332170	ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors	recruiting	Phase 1	610	Hansoh BioMedical R&D CompanyINDUSTRY	1	Jul 18, 2024	clinicaltrials
NCT06336707	HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors	recruiting	Phase 1	1,048	Hansoh BioMedical R&D CompanyINDUSTRY	1	Jul 18, 2024	clinicaltrials
NCT06504901	Evaluation of Efficacy and Safety of PD-1 Monoclonal Antibody in Combination With rhG-CSF, IL-2, and CapeOX in Initially Resectable Synchronous Colorectal Liver Metastases	not yet recruiting	—	30	The First Affiliated Hospital with Nanjing Medical UniversityOTHER	0	Jul 17, 2024	clinicaltrials

A study listed here tests a linked drug in a linked cancer; it does not necessarily select participants on this biomarker.

Bevacizumab

EU EMA

—

VEGZELMA in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. VEGZELMA in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. VEGZELMA in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with VEGZELMA in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. VEGZELMA, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (NSCLC) other than predominantly squamous cell histology. VEGZELMA, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). VEGZELMA, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. VEGZELMA, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). VEGZELMA, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor–targeted agents. VEGZELMA in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1). VEGZELMA, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

approved

Aug 17, 2022

ema

Bevacizumab

EU EMA

—

Abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Abevmy in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). Abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics [FIGO] stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1). Abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

approved

Apr 21, 2021

ema

Bevacizumab

EU EMA

—

Alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. Alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Alymsys in combination with capecitabine. Alymsys, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Alymsys, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Alymsys, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

approved

Mar 26, 2021

ema

Bevacizumab

EU EMA

—

Oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Oyavas in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Oyavas, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). Oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Oyavas, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Oyavas, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see Section 5.1). Oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

approved

Mar 26, 2021

ema

Bevacizumab

EU EMA

—

Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Onbevzi in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

withdrawn

Jan 11, 2021

ema

Bevacizumab

EU EMA

—

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Equidacent in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

withdrawn

Sep 24, 2020

ema

Bevacizumab

EU EMA

—

Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1 of the SmPC. Aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Aybintio in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1 of the SmPC. Aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1 of the SmPC). Aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1 of the SmPC). Aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see section 5.1 of the SmPC). Aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1 of the SmPC).

approved

Aug 19, 2020

ema

Bevacizumab

EU EMA

—

Mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Mvasi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Mvasi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. Mvasi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Mvasi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Mvasi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

approved

Jan 15, 2018

ema

Bevacizumab

EU EMA

—

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

approved

Jan 12, 2005

ema

Approval rows flagged tumor-agnostic (4)

Associated cancers (24)

Drugs with predictive evidence (29)

Predictive evidence items (92)

Approvals mentioning the linked drugs (364)

Active trials (473)

Linked publications (85)