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A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer

NCT04294160•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.

Detailed Description

This is a phase Ib, multi-center, open-label study with multiple treatment arms in adult patients with advanced or metastatic BRAF V600 (E, D, or K) in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies. The open platform design of this study is adaptive to allow removal of combination treatment arm(s) based on emerging data and facilitate introduction of new candidate combinations. The study is comprised of a dose escalation part and may be followed by a dose expansion part for any combination treatment arm.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. Exceptions may be considered after documented discussion with Novartis.
•All patients must have a BRAF V600 mutation confirmed by local assessment.
•Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1
•Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease

Exclusion Criteria

•Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy
•Impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs
•History of or current evidence/risk of retinal verin occlusion or serous retinopathy
•History of or current interstitial lung disease or non-infectious pneumonitis
•Patients with a known history of testing positive for HIV
•Clinically significant cardiac disease at screening
•Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
•Pregnant or lactating women
•Other protocol-defined inclusion/exclusion may apply.

Locations (18)

University of California LA Santa Monica Location

Los Angeles, California, United States

Massachusetts General Hospital Massachusetts General Hospital

Boston, Massachusetts, United States

Sarah Cannon Research Institute SC

Nashville, Tennessee, United States

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, United States

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Dresden, Germany

Novartis Investigative Site

Essen, Germany

Key Dates

Start Date

July 22, 2020

Primary Completion Date

September 25, 2024

Completion Date

September 25, 2024

Last Updated

December 24, 2025

Enrollment

122

ACTUAL participants

Conditions

BRAF V600 Colorectal Cancer

Interventions

Dabrafenib

DRUG

LTT462

DRUG

Trametinib

DRUG

LXH254

DRUG

TNO155

DRUG

Spartalizumab

BIOLOGICAL

Tislelizumab

BIOLOGICAL

Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer

NCT07150247

BRAF V600 Colorectal Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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