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New cocktail of drugs shows promise for Tough-to-Treat colorectal cancer

NCT ID NCT06967155

Disease control Sponsor: Blokhin's Russian Cancer Research Center 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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial is testing a combination of four drugs—irinotecan, dabrafenib, trametinib, and either cetuximab or panitumumab—as a second-line treatment for people with metastatic colorectal cancer that has a BRAF V600E mutation. The study aims to see how well this drug mix shrinks tumors and controls the disease. About 23 participants will be followed for up to three years to monitor response and side effects.

What this could mean

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

Active substance
Irinotecan, dabrafenib, trametinib, and cetuximab or panitumumab
What this could lead to
If successful, this could offer a new second-line treatment option for people with a specific type of advanced colorectal cancer that has a BRAF mutation.
What could go wrong
This is a small, early-phase trial with only 23 participants, so results may not apply to everyone. The drug combination can cause significant side effects, and it is not yet known if it will improve survival compared to existing treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 23 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: 1. Histologically confirmed metastatic inoperable colorectal adenocarcinoma 2. The tumour has a BRAF mutation 3. Adequate function of hematopoiesis and basic indicators of internal organs 4. Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1). 5. Absence of grade 2 or higher toxicity from previous line of treatment. 6. It is possible to include patients with MSI or dMMR if they have received first-line immune checkpoint therapy. 7. ECOG PS 0-1 Exclusion Criteria: 1. Participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and/or perioperative chemotherapy with oxaliplatin and fluoropyrimidines is acceptable). 2. Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment. 3. Pregnant and breastfeeding women. 4. Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study. 5. HIV-infected patients. 6. Patients with a life expectancy of less than 3 months. 7. The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm neoplasm

As listed by the trial registrant

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

Neoplasms

Contacts and locations

Locations

  • Blokhin's Russian Cancer Research Center

    Moscow, Moscow, 115478, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.