NCT04044430 is a Phase 1 clinical trial of Binimetinib in Metastatic Colon Adenocarcinoma, sponsored by University of California, San Francisco.

Who is sponsoring NCT04044430?

NCT04044430 is sponsored by University of California, San Francisco.

What drugs are being tested in NCT04044430?

Interventions in NCT04044430: Binimetinib, Encorafenib, Nivolumab, Questionnaire Administration.

What condition does NCT04044430 study?

NCT04044430 studies Metastatic Colon Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer, Stage III Colorectal Cancer, Stage III Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Colorectal Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Colorectal Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Colorectal Cancer, Stage IIIC Rectal Cancer, Stage IV Colon Cancer, Stage IV Colorectal Cancer, Stage IV Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Colorectal Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Colorectal Cancer, Stage IVB Rectal Cancer, Stage IVC Colon Cancer, Stage IVC Colorectal Cancer, Stage IVC Rectal Cancer.

Is NCT04044430 still recruiting?

NCT04044430 is currently terminated. Last updated 9 January 2023.

Last reviewed 2023-01-09 · How we verify

NCT04044430

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

Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer

Terminated Phase 1 Last updated 9 January 2023

What this trial tests

Phase 1 trial testing Binimetinib in Metastatic Colon Adenocarcinoma in 2 participants. Terminated before completion.

Timeline

31 August 2020

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	31 August 2020
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	2 locations across United States

Drugs / interventions tested

Binimetinib (binimetinib) — full drug profile →
Encorafenib (encorafenib) — full drug profile →
Nivolumab (nivolumab) — full drug profile →
Questionnaire Administration

Conditions studied

Metastatic Colon Adenocarcinoma — all drugs for Metastatic Colon Adenocarcinoma →
Metastatic Colorectal Adenocarcinoma — all drugs for Metastatic Colorectal Adenocarcinoma →
Metastatic Microsatellite Stable Colorectal Carcinoma — all drugs for Metastatic Microsatellite Stable Colorectal Carcinoma →
Metastatic Rectal Adenocarcinoma — all drugs for Metastatic Rectal Adenocarcinoma →

Sponsor

University of California, San Francisco

Who can join

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

Sponsor's own description

This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.

Publications & conference data

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

Immunosuppressive tumor microenvironment modulation by chemotherapies and targeted therapies to enhance immunotherapy effectiveness.
Barnestein R, Galland L, Kalfeist L, Ghiringhelli F, et al · · 2022 · cited 66× · PMID 36117524 · DOI 10.1080/2162402x.2022.2120676
Current Insights into Combination Therapies with MAPK Inhibitors and Immune Checkpoint Blockade.
Shin MH, Kim J, Lim SA, Kim J, et al · · 2020 · cited 59× · PMID 32260561 · DOI 10.3390/ijms21072531
The Evolutionary Landscape of Treatment for <i>BRAF<sup>V600E</sup></i> Mutant Metastatic Colorectal Cancer.
Mauri G, Bonazzina E, Amatu A, Tosi F, et al · · 2021 · cited 53× · PMID 33406649 · DOI 10.3390/cancers13010137
Immune Checkpoint Inhibitors in pMMR Metastatic Colorectal Cancer: A Tough Challenge.
Marmorino F, Boccaccino A, Germani MM, Falcone A, et al · · 2020 · cited 39× · PMID 32824490 · DOI 10.3390/cancers12082317
Molecular-Biology-Driven Treatment for Metastatic Colorectal Cancer.
Lai E, Liscia N, Donisi C, Mariani S, et al · · 2020 · cited 32× · PMID 32413973 · DOI 10.3390/cancers12051214
Molecular Targets for the Treatment of Metastatic Colorectal Cancer.
Cohen R, Pudlarz T, Delattre JF, Colle R, et al · · 2020 · cited 31× · PMID 32825275 · DOI 10.3390/cancers12092350
Immunotherapy: Recent Advances and Its Future as a Neoadjuvant, Adjuvant, and Primary Treatment in Colorectal Cancer.
Yu I, Dakwar A, Takabe K. · · 2023 · cited 27× · PMID 36672193 · DOI 10.3390/cells12020258
Colorectal cancer and therapy response: a focus on the main mechanisms involved.
Tirendi S, Marengo B, Domenicotti C, Bassi AM, et al · · 2023 · cited 24× · PMID 37538108 · DOI 10.3389/fonc.2023.1208140

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 Metastatic Colon Adenocarcinoma

Currently open trials in the same condition.

NCT05627635 — FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite · Phase 1, PHASE2 · active not recruiting
NCT05308446 — Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer T · Phase 2 · active not recruiting
NCT04616183 — LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorec · Phase 1, PHASE2 · active not recruiting
NCT04599140 — SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC · Phase 1, PHASE2 · active not recruiting
NCT03992456 — Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal · Phase 2 · active not recruiting

Other University of California, San Francisco trials

Trials by the same sponsor.

NCT05284773 — Screening for Acute Malnutrition · NA · withdrawn
NCT04634851 — Video Home Visits for Dietary Counselling · NA · not yet recruiting
NCT06065670 — Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a M · Phase 1, PHASE2 · not yet recruiting
NCT07534098 — Intervention for Hearing Health Among Native Americans · NA · not yet recruiting
NCT06960421 — Exercise-based Frailty Intervention in Lung Transplantation (XFIT) · NA · not yet recruiting

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 NCT04044430 (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 University of California, San Francisco
Last refreshed: 9 January 2023

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/NCT04044430.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing