ACTIVE_NOT_RECRUITING

Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)

Conditions

Advanced Biliary Tract Carcinoma Advanced Gallbladder Carcinoma Advanced Intrahepatic Cholangiocarcinoma Recurrent Biliary Tract Carcinoma Recurrent Gallbladder Carcinoma Recurrent Intrahepatic Cholangiocarcinoma Stage III Distal Bile Duct Cancer AJCC v8 Stage III Gallbladder Cancer AJCC v8 Stage III Hilar Cholangiocarcinoma AJCC v8 Stage III Intrahepatic Cholangiocarcinoma AJCC v8 Stage IV Distal Bile Duct Cancer AJCC v8 Stage IV Gallbladder Cancer AJCC v8 Stage IV Hilar Cholangiocarcinoma AJCC v8 Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 Unresectable Biliary Tract Carcinoma Unresectable Gallbladder Carcinoma Unresectable Intrahepatic Cholangiocarcinoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial

Quick Facts

Study Start:2024-02-09

Study Completion:2026-01-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05564403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-A6 based on the presence of an actionable mutation as defined in EAY191 * GENERAL COMBOMATCH EAY191: * Patients must be registered to the ComboMATCH Registration Protocol (EAY191) * Patients must have RAS/RAF/MEK/ERK mutations as determined by the ComboMATCH screening assessment * Patients must not have BRAF V600E as determined by the ComboMATCH screening assessment * Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to registration on the ComboMATCH Registration Trial (EAY191). * Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website * Please note novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH Registration Protocol * EAY191-A6 REGISTRATION: * Participants must have histologically confirmed BTC (intrahepatic cholangiocarcinoma \[IHC\], extrahepatic cholangiocarcinoma \[EHC\] or gallbladder cancer \[GBC\]) that is unresectable or recurrent with a confirmed RAS/RAF/MEK/ERK pathway mutation via any Clinical Laboratory Improvement Act (CLIA)-certified method. BRAFV600E mutations are not eligible due to other ongoing/upcoming studies in this disease cohort * Tumor tissue must be available: * Adequate archival tumor specimen (obtained within 12 months of EAY191 registration which has not had a Response Evaluation Criteria in Solid Tumors (RECIST) response, complete response (CR) or partial response (PR), to any intervening therapy after collection of the tissue) must be available with formalin-fixed paraffin-embedded tumor tissue (blocks or slides) OR * Consent to a new tumor tissue biopsy which is not a representative target lesion. This lesion must be amenable to a minimal risk image-guided or direct vision biopsy * A new biopsy is preferred but is not required for enrollment in EAY191-A6 if sufficient archival tissue is available as described above. * Measurable disease per RECIST 1.1 Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable per RECIST 1.1. All radiologic studies must be performed within 28 days prior to registration * Progression of disease on gemcitabine based first-line regimen (i.e. only one prior line of therapy is permitted) * No systemic anti-cancer therapy within 4 weeks of registration to EAY191-A6 * No prior MEK inhibitor therapy * No prior history of treatment with a direct and specific inhibitor of KRAS * Patients who only received radio-sensitizing chemotherapy with fluorouracil (5-FU) or capecitabine are eligible, but need to have received and failed first-line systemic chemotherapy upon recurrence. Peri-operative systemic 5-FU/capecitabine and/or oxaliplatin, is allowed if it's been more than 12 months of registration to EAY191-A6 * No major surgery within 4 weeks (excluding placement of vascular access) of registration to EAY191-A6 * No minor surgery within 2 weeks of registration to EAY191-A6 * No palliative radiotherapy within 1 week of registration to EAY191-A6 * Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown * Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required * Adequate contraception is needed for at least 30 days after the last dose of binimetinib and breastfeeding should be discontinued for at least 3 days after the last dose of binimetinib. For FOLFOX regimen, 9 months is recommended for contraception after last dose of oxaliplatin for females of childbearing potential and 6 months for males * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Absolute neutrophil count (ANC) \>= 1,000/mm\^3, no growth factor within 14 days of 1st dose * Platelet count \>= 75,000/mm\^3 * Creatinine \< 1.6 x upper limit of normal (ULN) OR * Calculated (Calc.) creatinine clearance \>= 50 mL/min, as calculated by the Cockcroft-Gault formula * Total bilirubin =\< 2.0 x upper limit of normal (ULN); Patients with Gilbert syndrome may enroll if \< 3.0 x ULN * Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) =\< 5.0 x upper limit of normal (ULN) * Hemoglobin \>= 8 g/dL, no transfusion within 7 days of 1st dose * Creatine phosphokinase =\< 2.5 x ULN * High blood pressure more than 160/90 despite treatment are ineligible * No history of interstitial lung disease. No history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Patients should not have history of bowel perforation or intestinal fistulas in the last 6 months * Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease are ineligible * Must have adequate cardiac function with left ventricular ejection fraction \>= 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan. Patients with congenital long QT syndrome are not permitted * No history of prolonged QTc or at risk for prolonged QTc due to any reason (for example, concomitant medications during or before chemotherapy that may increase the risk of prolonged QTc), uncontrolled congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\]), myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina or severe obstructive pulmonary disease * No active skin disorder that has required systemic therapy within the past 1 year * No history of rhabdomyolysis * No concurrent ocular disorders, including: * Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including but not limited to uncontrolled hypertension, uncontrolled diabetes * Patients with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO * Patients with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions * Patients with known or at risk for retinopathies, uveitis or retinal vein occlusion * No patients with a history of hypersensitivity to any of the inactive ingredients in binimetinib, nor known severe allergic reactions or hypersensitivity of 5-FU, leucovorin (LV) or oxaliplatin will be allowed to participate in this study for safety concerns * No other medical condition (e.g. cardiac, gastrointestinal, pulmonary, psychiatric, neurological, genetic, etc.) that in the opinion of the investigator would places the subject at unacceptably high risk for toxicity * No prior allogeneic stem cell or solid organ transplantation * Central nervous system (CNS) metastases must have been treated with local therapy (surgery, radiation, ablation) with systemic steroids tapered to a physiologic dose (10 mg or prednisone equivalent or less) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients must not have grade 2 neuropathy or greater, within 14 days prior to registration	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-A6 based on the presence of an actionable mutation as defined in EAY191
* GENERAL COMBOMATCH EAY191:
* Patients must be registered to the ComboMATCH Registration Protocol (EAY191)
* Patients must have RAS/RAF/MEK/ERK mutations as determined by the ComboMATCH screening assessment
* Patients must not have BRAF V600E as determined by the ComboMATCH screening assessment
* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to registration on the ComboMATCH Registration Trial (EAY191).
* Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website
* Please note novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH Registration Protocol
* EAY191-A6 REGISTRATION:
* Participants must have histologically confirmed BTC (intrahepatic cholangiocarcinoma \[IHC\], extrahepatic cholangiocarcinoma \[EHC\] or gallbladder cancer \[GBC\]) that is unresectable or recurrent with a confirmed RAS/RAF/MEK/ERK pathway mutation via any Clinical Laboratory Improvement Act (CLIA)-certified method. BRAFV600E mutations are not eligible due to other ongoing/upcoming studies in this disease cohort
* Tumor tissue must be available:
* Adequate archival tumor specimen (obtained within 12 months of EAY191 registration which has not had a Response Evaluation Criteria in Solid Tumors (RECIST) response, complete response (CR) or partial response (PR), to any intervening therapy after collection of the tissue) must be available with formalin-fixed paraffin-embedded tumor tissue (blocks or slides) OR
* Consent to a new tumor tissue biopsy which is not a representative target lesion. This lesion must be amenable to a minimal risk image-guided or direct vision biopsy
* A new biopsy is preferred but is not required for enrollment in EAY191-A6 if sufficient archival tissue is available as described above.
* Measurable disease per RECIST 1.1 Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable per RECIST 1.1. All radiologic studies must be performed within 28 days prior to registration
* Progression of disease on gemcitabine based first-line regimen (i.e. only one prior line of therapy is permitted)
* No systemic anti-cancer therapy within 4 weeks of registration to EAY191-A6
* No prior MEK inhibitor therapy
* No prior history of treatment with a direct and specific inhibitor of KRAS
* Patients who only received radio-sensitizing chemotherapy with fluorouracil (5-FU) or capecitabine are eligible, but need to have received and failed first-line systemic chemotherapy upon recurrence. Peri-operative systemic 5-FU/capecitabine and/or oxaliplatin, is allowed if it's been more than 12 months of registration to EAY191-A6
* No major surgery within 4 weeks (excluding placement of vascular access) of registration to EAY191-A6
* No minor surgery within 2 weeks of registration to EAY191-A6
* No palliative radiotherapy within 1 week of registration to EAY191-A6
* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
* Adequate contraception is needed for at least 30 days after the last dose of binimetinib and breastfeeding should be discontinued for at least 3 days after the last dose of binimetinib. For FOLFOX regimen, 9 months is recommended for contraception after last dose of oxaliplatin for females of childbearing potential and 6 months for males
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3, no growth factor within 14 days of 1st dose
* Platelet count \>= 75,000/mm\^3
* Creatinine \< 1.6 x upper limit of normal (ULN) OR
* Calculated (Calc.) creatinine clearance \>= 50 mL/min, as calculated by the Cockcroft-Gault formula
* Total bilirubin =\< 2.0 x upper limit of normal (ULN); Patients with Gilbert syndrome may enroll if \< 3.0 x ULN
* Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) =\< 5.0 x upper limit of normal (ULN)
* Hemoglobin \>= 8 g/dL, no transfusion within 7 days of 1st dose
* Creatine phosphokinase =\< 2.5 x ULN
* High blood pressure more than 160/90 despite treatment are ineligible
* No history of interstitial lung disease. No history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Patients should not have history of bowel perforation or intestinal fistulas in the last 6 months
* Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease are ineligible
* Must have adequate cardiac function with left ventricular ejection fraction \>= 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan. Patients with congenital long QT syndrome are not permitted
* No history of prolonged QTc or at risk for prolonged QTc due to any reason (for example, concomitant medications during or before chemotherapy that may increase the risk of prolonged QTc), uncontrolled congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\]), myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina or severe obstructive pulmonary disease
* No active skin disorder that has required systemic therapy within the past 1 year
* No history of rhabdomyolysis
* No concurrent ocular disorders, including:
* Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including but not limited to uncontrolled hypertension, uncontrolled diabetes
* Patients with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO
* Patients with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions
* Patients with known or at risk for retinopathies, uveitis or retinal vein occlusion
* No patients with a history of hypersensitivity to any of the inactive ingredients in binimetinib, nor known severe allergic reactions or hypersensitivity of 5-FU, leucovorin (LV) or oxaliplatin will be allowed to participate in this study for safety concerns
* No other medical condition (e.g. cardiac, gastrointestinal, pulmonary, psychiatric, neurological, genetic, etc.) that in the opinion of the investigator would places the subject at unacceptably high risk for toxicity
* No prior allogeneic stem cell or solid organ transplantation
* Central nervous system (CNS) metastases must have been treated with local therapy (surgery, radiation, ablation) with systemic steroids tapered to a physiologic dose (10 mg or prednisone equivalent or less)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients must not have grade 2 neuropathy or greater, within 14 days prior to registration

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Ardaman Shergill

PRINCIPAL_INVESTIGATOR

Alliance for Clinical Trials in Oncology

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688

United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054

United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401

United States

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Presbyterian Intercommunity Hospital

Whittier, California, 90602

United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813

United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813

United States

Queen's Medical Center

Honolulu, Hawaii, 96813

United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817

United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701

United States

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, 96706

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

Northwestern University

Chicago, Illinois, 60611

United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657

United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Advocate Sherman Hospital

Elgin, Illinois, 60123

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026

United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030

United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Condell Memorial Hospital

Libertyville, Illinois, 60048

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462

United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Memorial Hospital East

Shiloh, Illinois, 62269

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

United States

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

UPMC Western Maryland

Cumberland, Maryland, 21502

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124

United States

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, 48336

United States

Cancer Hematology Centers - Flint

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085

United States

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636

United States

Essentia Health Cancer Center

Duluth, Minnesota, 55805

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Essentia Health Sandstone

Sandstone, Minnesota, 55072

United States

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792

United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705

United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901

United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652

United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655

United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Washington University School of Medicine

St Louis, Missouri, 63110

United States

Siteman Cancer Center-South County

St Louis, Missouri, 63129

United States

Missouri Baptist Medical Center

St Louis, Missouri, 63131

United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Logan Health Medical Center

Kalispell, Montana, 59901

United States

Community Medical Center

Missoula, Montana, 59804

United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123

United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052

United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102

United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148

United States

Renown Regional Medical Center

Reno, Nevada, 89502

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017

United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120

United States

MD Anderson in The Woodlands

Conroe, Texas, 77384

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

MD Anderson West Houston

Houston, Texas, 77079

United States

MD Anderson League City

League City, Texas, 77573

United States

MD Anderson in Sugar Land

Sugar Land, Texas, 77478

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

Virginia Cancer Institute

Richmond, Virginia, 23229

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298

United States

VCU Community Memorial Health Center

South Hill, Virginia, 23970

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

United States

Valley Medical Center

Renton, Washington, 98055

United States

Swedish Medical Center-First Hill

Seattle, Washington, 98122

United States

West Virginia University Healthcare

Morgantown, West Virginia, 26506

United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

United States

Duluth Clinic Ashland

Ashland, Wisconsin, 54806

United States

ThedaCare Cancer Care - Berlin

Berlin, Wisconsin, 54923

United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105

United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110

United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

ThedaCare Regional Medical Center - Neenah

Neenah, Wisconsin, 54956

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Ardaman Shergill, PRINCIPAL_INVESTIGATOR, Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-09

Study Completion Date2026-01-21

Study Record Updates

Study Start Date2024-02-09

Study Completion Date2026-01-21

Terms related to this study

Additional Relevant MeSH Terms

Advanced Biliary Tract Carcinoma
Advanced Gallbladder Carcinoma
Advanced Intrahepatic Cholangiocarcinoma
Recurrent Biliary Tract Carcinoma
Recurrent Gallbladder Carcinoma
Recurrent Intrahepatic Cholangiocarcinoma
Stage III Distal Bile Duct Cancer AJCC v8
Stage III Gallbladder Cancer AJCC v8
Stage III Hilar Cholangiocarcinoma AJCC v8
Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Stage IV Distal Bile Duct Cancer AJCC v8
Stage IV Gallbladder Cancer AJCC v8
Stage IV Hilar Cholangiocarcinoma AJCC v8
Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
Unresectable Biliary Tract Carcinoma
Unresectable Gallbladder Carcinoma
Unresectable Intrahepatic Cholangiocarcinoma