Study on Chemotherapy, With or Without Binimetinib, for Advanced Biliary Tract Cancers in Second-Line Treatment

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05564403

Provider View

This clinical trial is testing whether adding the drug binimetinib to the usual chemotherapy can help shrink tumors in patients with advanced biliary tract cancers that have spread and progressed after previous treatments.

Patient Parameters

Program Overview

This study is exploring whether a new combination of treatments can help control advanced biliary tract cancers that have spread and not responded to initial treatments. The trial compares the standard chemotherapy treatment (mFOLFOX6) with a combination of mFOLFOX6 and a new drug called binimetinib. The goal is to see if this combination can better shrink or stabilize tumors in patients who have already tried other treatments.

Description

The main goal of this study is to find out if adding binimetinib to the standard chemotherapy treatment (mFOLFOX6) can help patients with advanced biliary tract cancer live longer compared to using mFOLFOX6 alone. Researchers are also looking at whether this combination improves the rate at which tumors shrink and how long patients can go without the cancer getting worse.

The study will also monitor the side effects and how well patients tolerate the treatments. Tissue samples will be collected to study the genetic changes in the cancer and how they relate to treatment outcomes.

Patients in the study will be randomly assigned to one of two groups. One group will receive the standard chemotherapy treatment, while the other group will receive the same chemotherapy plus binimetinib. Both groups will undergo various tests and scans to monitor their health and the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every 8 weeks to check for disease progression and every 4 months for survival for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be part of the ComboMATCH study and have a specific genetic mutation that makes them eligible for this trial.
  • Must have advanced biliary tract cancer that cannot be removed by surgery or has come back after treatment.
  • Must have a specific type of genetic mutation in the RAS/RAF/MEK/ERK pathway.
  • Must have cancer that can be safely biopsied or have a recent tissue sample available.
  • Must have measurable disease according to specific criteria.
  • Must have had disease progression after first-line treatment with gemcitabine-based chemotherapy.
  • Must not have received any cancer treatment within 4 weeks before starting the study.
  • Must not have been treated with a MEK inhibitor or a specific KRAS inhibitor before.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they are able to carry out daily activities with minimal assistance.
  • Must have adequate blood counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Must not have any major surgeries or radiation therapy shortly before starting the study.
  • Must not have any active lung disease or heart conditions that could increase the risk of treatment.
  • Must not have any active skin or eye disorders that could be worsened by the treatment.
  • Must not have any severe allergies to the study drugs.
  • Must not have any other medical conditions that could increase the risk of treatment.
  • Must not have had a stem cell or organ transplant.
  • Must not have untreated brain metastases.
  • HIV-positive patients must be on effective treatment with an undetectable viral load.
  • Patients with hepatitis B or C must have the infection under control or cured.

Exclusion Criteria

  • Must not have a specific BRAF V600E mutation.
  • Must not have high blood pressure that is not controlled with medication.
  • Must not have had recent bowel perforation or intestinal fistulas.
  • Must be able to swallow oral medications and have normal gastrointestinal absorption.

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