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

NCT ID: NCT04294160

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2024-09-25

Brief Summary

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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

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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.

Conditions

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BRAF V600 Colorectal Cancer

Keywords

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Phase Ib, BRAF-mutated, BRAF V600E, BRAF V600D, BRAF V600K, colorectal cancer, colon cancer, rectal cancer, metastatic, BLRM with EWOC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dabrafenib + LTT462 backbone arm 1

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type DRUG

Capsule for oral use

LTT462

Intervention Type DRUG

Capsule for oral use

Dabrafenib + LTT462 + trametinib triplet arm 1

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type DRUG

Capsule for oral use

LTT462

Intervention Type DRUG

Capsule for oral use

Trametinib

Intervention Type DRUG

Tablet for oral use

Dabrafenib + LTT462 + LXH254 triplet arm 2

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type DRUG

Capsule for oral use

LTT462

Intervention Type DRUG

Capsule for oral use

LXH254

Intervention Type DRUG

Tablet for oral use

Dabrafenib + LTT462 + TNO155 triplet arm 3

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type DRUG

Capsule for oral use

LTT462

Intervention Type DRUG

Capsule for oral use

TNO155

Intervention Type DRUG

Capsule for oral use

Dabrafenib + LTT462 + spartalizumab triplet arm 4

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type DRUG

Capsule for oral use

LTT462

Intervention Type DRUG

Capsule for oral use

Spartalizumab

Intervention Type BIOLOGICAL

Liquid in vial (Concentrate for solution for infusion) for intravenous use

Dabrafenib + trametinib + TNO155 triplet arm 5

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type DRUG

Capsule for oral use

Trametinib

Intervention Type DRUG

Tablet for oral use

TNO155

Intervention Type DRUG

Capsule for oral use

Dabrafenib + LTT462 + Tislelizumab triplet arm 6

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type DRUG

Capsule for oral use

LTT462

Intervention Type DRUG

Capsule for oral use

Tislelizumab

Intervention Type BIOLOGICAL

Liquid in vial (Concentrate for solution for infusion) for intravenous use

Interventions

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Dabrafenib

Capsule for oral use

Intervention Type DRUG

LTT462

Capsule for oral use

Intervention Type DRUG

Trametinib

Tablet for oral use

Intervention Type DRUG

LXH254

Tablet for oral use

Intervention Type DRUG

TNO155

Capsule for oral use

Intervention Type DRUG

Spartalizumab

Liquid in vial (Concentrate for solution for infusion) for intravenous use

Intervention Type BIOLOGICAL

Tislelizumab

Liquid in vial (Concentrate for solution for infusion) for intravenous use

Intervention Type BIOLOGICAL

Other Intervention Names

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DRB436, Tafinlar TMT212, Mekinist PDR001 VDT482, BGBA317

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of California LA Santa Monica Location

Los Angeles, California, United States

Site Status

Massachusetts General Hospital Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Sarah Cannon Research Institute SC

Nashville, Tennessee, United States

Site Status

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, United States

Site Status

Novartis Investigative Site

Westmead, New South Wales, Australia

Site Status

Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Ulm, , Germany

Site Status

Novartis Investigative Site

Tel Aviv, , Israel

Site Status

Novartis Investigative Site

Zoetermeer, , Netherlands

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Manchester, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada Germany Israel Netherlands Singapore Spain United Kingdom

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18353

CADPT01C12101 Clinical Trial results Form

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2873

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

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CADPT01C12101

Identifier Type: -

Identifier Source: org_study_id