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NCT05564403 · ClinicalTrials.gov registry record · Phase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
A Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Advanced Biliary Tract Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT05564403: Active Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Advanced Biliary Tract Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05564403 is a Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Advanced Biliary Tract Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, above the 35-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05564403, a Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Advanced Biliary Tract Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II ComboMATCH treatment trial compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (advanced) and had progression of cancer after previous treatments (2nd line setting). Fluorouracil is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It works by killing tumor cells. Leucovorin may help the other drugs in the mFOLFOX6 chemotherapy regimen work better by making tumor cells more sensitive to the drugs. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps to stop or slow the spread of tumor cells. Giving binimetinib in combination with mFOLFOX6 chemotherapy may be effective in shrinking or stabilizing advanced biliary tract cancers in the 2nd line setting.
Primary Outcome
The primary efficacy analysis will be to compare the OS distributions between those treated with modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) and binimetinib versus (vs.) mFOLFOX6. Despite being a randomized phase II trial, we will utilize an intent to treat approach such that patients will be analyzed based on the treatment arm to which they were randomized. As defined above, OS will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio, median
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
- DRUG Binimetinib
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UF Health Cancer Institute - Gainesville - Gainesville
- Mayo Clinic in Florida - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
- Queen's Cancer Cenrer - POB I - Honolulu
- Queen's Medical Center - Honolulu
- Queen's Cancer Center - Kuakini - Honolulu
- Hawaii Cancer Care - Westridge - ‘Aiea
California
- UC San Diego Moores Cancer Center - La Jolla
- Cedars Sinai Medical Center - Los Angeles
- Presbyterian Intercommunity Hospital - Whittier
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2024-02-09 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 2 |
What the registry record for NCT05564403 still lists
NCT05564403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 35-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (89% higher).
The record links to 10 conditions, with Stage III Intrahepatic Cholangiocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05564403 names 20 study sites across 6 states, led by Florida, Hawaii, California.
Frequently Asked Questions
What is clinical trial NCT05564403 about?
NCT05564403 is a clinical study titled "Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)". This phase II ComboMATCH treatment trial compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (adv...
What is the current status of trial NCT05564403?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2024-02-09. Estimated completion is 2026-05-01.
What conditions does trial NCT05564403 study?
This clinical trial studies the following conditions: Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Advanced Biliary Tract Carcinoma, Recurrent Gallbladder Carcinoma, Recurrent Intrahepatic Cholangiocarcinoma, Stage III Gallbladder Cancer AJCC v8.
What interventions are being tested in trial NCT05564403?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE), Binimetinib (DRUG).
Who is sponsoring clinical trial NCT05564403?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05564403 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05564403's enrollment target sits among peer trials
66 3rd of 8 higher than 6 of 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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