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New drug cocktails tested for tough colorectal cancer

NCT ID NCT04294160

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested several drug combinations in 122 adults with advanced or metastatic BRAF V600 colorectal cancer. The goal was to find safe doses and understand side effects. The trial was terminated, so final results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dabrafenib, Trametinib, LTT462, LXH254, TNO155, Spartalizumab, Tislelizumab
What this could lead to
If successful, this could help identify safer and more effective drug combinations for treating advanced BRAF V600 colorectal cancer.
What could go wrong
This was a very early (Phase 1) study that was terminated, so results are limited. The combinations may not work better than existing treatments and could have significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

122 people

The number who actually took part.

Started

Jul 2020

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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 Key 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.

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer colorectal neoplasm Neoplasm Metastasis rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRAF V600 colorectal cancer

Contacts and locations

Locations

  • Massachusetts General Hospital Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    Westmead, New South Wales, 2145, Australia

  • Novartis Investigative Site

    Brussels, 1000, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Zoetermeer, NL-2722 EP, Netherlands

  • Novartis Investigative Site

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • Novartis Investigative Site

    Valencia, Valencia, 46010, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Sarah Cannon Research Institute SC

    Nashville, Tennessee, 37203, United States

  • Uni Of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030, United States

  • University of California LA Santa Monica Location

    Los Angeles, California, 90095, United States

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