NCT05510895 (NeoBRAF) is a Phase 2 clinical trial of Binimetinib in Colorectal Cancer, sponsored by AIO-Studien-gGmbH.

Who is sponsoring NCT05510895?

NCT05510895 is sponsored by AIO-Studien-gGmbH.

What drugs are being tested in NCT05510895?

Interventions in NCT05510895: Binimetinib.

What condition does NCT05510895 study?

NCT05510895 studies Colorectal Cancer, Colon Cancer, BRAF V600E, BRAF V600 Mutation, Localized Cancer.

Is NCT05510895 still recruiting?

NCT05510895 is currently completed. Last updated 1 October 2025.

Last reviewed 2025-10-01 · How we verify

NCT05510895: NeoBRAF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer

Completed Phase 2 Last updated 1 October 2025

What this trial tests

Phase 2 trial testing Binimetinib in Colorectal Cancer in 2 participants. Completed in 31 January 2025.

Timeline

1 September 2022

Primary endpoint
31 July 2024

31 January 2025

Quick facts

Lead sponsor	AIO-Studien-gGmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	1 September 2022
Primary completion	31 July 2024
Estimated completion	31 January 2025
Sites	1 location across Germany

Drugs / interventions tested

Binimetinib (binimetinib) — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Colon Cancer — all drugs for Colon Cancer →
BRAF V600E — all drugs for BRAF V600E →
BRAF V600 Mutation — all drugs for BRAF V600 Mutation →

Sponsor

AIO-Studien-gGmbH — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

AIO-KRK-0420 NeoBRAF is a single arm, multicenter, phase II trial with neoadjuvant encorafenib, binimetinib and cetuximab for patients with BRAF V600E mutated/pMMR localized colorectal cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

BRAF - a tumour-agnostic drug target with lineage-specific dependencies.
Hanrahan AJ, Chen Z, Rosen N, Solit DB. · · 2024 · cited 92× · PMID 38278874 · DOI 10.1038/s41571-023-00852-0
Different prognostic values of KRAS exon 2 submutations and BRAF V600E mutation in microsatellite stable (MSS) and unstable (MSI) stage III colon cancer: an ACCENT/IDEA pooled analysis of seven trials.
Taieb J, Sinicrope FA, Pederson L, Lonardi S, et al · · 2023 · cited 30× · PMID 37619846 · DOI 10.1016/j.annonc.2023.08.006
Current and emerging concepts for systemic treatment of metastatic colorectal cancer.
Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, et al · · 2025 · cited 10× · PMID 41047178 · DOI 10.1136/gutjnl-2025-335412
A comprehensive overview of the molecular features and therapeutic targets in BRAF<sup>V600E</sup>-mutant colorectal cancer.
Gu R, Fang H, Wang R, Dai W, et al · · 2024 · cited 8× · PMID 39073010 · DOI 10.1002/ctm2.1764
Molecular Landscape and Therapeutic Strategies against Colorectal Cancer.
Patel A, Gulhati P. · · 2024 · cited 7× · PMID 38672633 · DOI 10.3390/cancers16081551
Clinical research progress on BRAF V600E-mutant advanced colorectal cancer.
Zeng C, Wang M, Xie S, Wang N, et al · · 2023 · cited 7× · PMID 37639010 · DOI 10.1007/s00432-023-05301-0
Preoperative Strategies for Locally Advanced Colon Cancer.
Nair KG, Kamath SD, Chowattukunnel N, Krishnamurthi SS. · · 2024 · cited 5× · PMID 38349502 · DOI 10.1007/s11864-024-01184-6
European screening platform for EORTC clinical trials in advanced colorectal cancer 'SPECTAcolor'.
Folprecht G, Morfouace M, Collienne M, Salazar R, et al · · 2025 · PMID 41646282 · DOI 10.1016/j.esmogo.2025.100168

Verify or expand the search:

Other trials of Binimetinib

Trials testing the same drug.

NCT05554354 — Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastat · Phase 2 · terminated
NCT05564403 — Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH T · Phase 2 · active not recruiting
NCT04870034 — Binimetinib and Palbociclib Before Surgery for the Treatment of Operable KRAS-Positive Lung, Colorectal, or Pancreatic C · EARLY_PHASE1 · withdrawn
NCT05554367 — Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial · Phase 2 · active not recruiting
NCT05304546 — Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma · Phase 2 · completed

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other AIO-Studien-gGmbH trials

Trials by the same sponsor.

NCT05190263 — Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma · completed
NCT04727541 — Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer · Phase 2 · terminated
NCT04172467 — Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients · completed
NCT04221529 — Patients With ES-SCLC and ECOG PS=2 Receiving Atezolizumab-Carboplatin-Etoposide · Phase 2 · completed
NCT03620123 — A Randomized Phase II Study on the Optimization of Immunotherapy in Squamous Carcinoma of the Head and Neck · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05510895 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AIO-Studien-gGmbH
Last refreshed: 1 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05510895.

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