Trial: Study of Chemotherapy, With or Without …

Trial Details

Sponsor: National Cancer Institute (NCI) (federal)

Phase: 2

Start date: Feb. 9, 2024

Planned enrollment: 66

Trial ID: NCT05564403

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

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.

More details:

PRIMARY OBJECTIVE: I. To determine whether binimetinib and mFOLFOX6 combination therapy improves overall survival (OS) compared to mFOLFOX6 alone in patients with advanced/recurrent biliary tract cancer (BTC) and with alterations in RAS/RAF/MEK/ERK pathway, who have progressed on one prior line of therapy. SECONDARY OBJECTIVES: I. To determine whether binimetinib and mFOLFOX6 combination therapy improves objective response rate (ORR) compared to FOLFOX alone. II. To determine if clinical outcomes including progression free survival (PFS), duration of response (DOR), and disease control rate (DCR) are improved with combination treatment of binimetinib and mFOLFOX6 compared to FOLFOX alone in patients with advanced/recurrent BTC and with alterations in RAS/RAF/MEK/ERK pathway who have progression on one prior line of therapy. III. Toxicity and tolerability will be evaluated within and between the two treatment arms, where frequency, type, and severity of adverse events will be assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v)5.0. IV. Collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutation profile from plasma, as described in ComboMATCH Registration Protocol. EXPLORATORY OBJECTIVES: I. Generate a prognostic model of MAPK mutations for this patient population using clinical, laboratory and molecular features of their disease and clinical outcome to validate on future samples. II. Correlation of outcome with albumin. III. Assess the correlation between the presence of MAPK pathway mutations and activity of addition of binimetinib therapy to standard 2nd line chemotherapy. IV. Conduct whole-exome sequencing and ribonucleic acid (RNA)-sequencing at baseline, and on optional biopsy upon progression to assess determinants of response and resistance. V. Explore changes in plasma MAPK mutations allelic burden and other molecular findings at baseline and upon progression using ctDNA and correlate changes with clinical activity, disease course as well as response/resistance to therapy. VI. Evaluate if our machine learning algorithm for RAS/RAF/MEK/ERK pathway mutations correlates with detection of mutations as well as prediction of outcomes from samples obtained in this study. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive leucovorin intravenously (IV) over 2 hours and oxaliplatin IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood during screening and on study, and undergo computed tomography (CT) with contrast, magnetic resonance imaging (MRI), or fludeoxyglucose F-18 positron emission tomography (FDG-PET) throughout the trial as clinically indicated. Patients may also undergo bone scans on study and may undergo biopsies throughout the study as clinically indicated. ARM 2: Patients receive binimetinib orally (PO) on days 1-14, and leucovorin IV, oxaliplatin IV, and fluorouracil IV as in Arm 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiogram (ECHO) or multigated acquisition scan (MUGA) and collection of blood during screening and on study, and undergo CT with contrast, MRI, or FDG-PET throughout the trial as clinically indicated. Patients may also undergo bone scans on study and may undergo biopsies throughout the study as clinically indicated. After completion of study treatment, patients are followed up every 8 weeks until disease progression, thereafter patients are followed for survival every 4 months for up to 5 years following registration.

Investigational Drug AI Analysis

No investigational drugs.

HealthScout AI Analysis

Goal: Evaluate whether adding the MEK inhibitor binimetinib to standard second-line mFOLFOX6 improves overall survival in patients with advanced or recurrent biliary tract cancers harboring MAPK pathway alterations (RAS/RAF/MEK/ERK), excluding BRAF V600E.

Patients: Adults (ECOG 0-2) with unresectable or recurrent biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or gallbladder cancer) who have progressed after one gemcitabine-based first-line regimen and have a qualifying MAPK pathway mutation per ComboMATCH testing (excluding BRAF V600E). Measurable disease is required. Adequate organ function and cardiac function (LVEF ≥50%) are mandated; key exclusions include prior MEK inhibitor or direct KRAS inhibitor, significant cardiac risk, uncontrolled hypertension, interstitial lung disease, significant ocular disease at risk for RVO, grade ≥2 neuropathy, recent major surgery, and inability to swallow oral meds. Treated/stable CNS metastases are allowed; controlled HIV, HBV, and HCV infections are permitted.

Design: Randomized phase II ComboMATCH treatment trial with two arms (mFOLFOX6 vs binimetinib plus mFOLFOX6), intent-to-treat analysis, 1:1 allocation. Imaging and biospecimen collection are integrated; follow-up every 8 weeks until progression, then survival follow-up every 4 months up to 5 years.

Treatments: Control: mFOLFOX6 (oxaliplatin and leucovorin IV day 1; 46–48-hour continuous infusion 5-FU days 1–2) every 14 days. Experimental: binimetinib orally twice daily on days 1–14 of each 14-day cycle plus the same mFOLFOX6 schedule. Binimetinib is an investigational MEK1/2 inhibitor that targets the MAPK pathway to block downstream ERK signaling, aiming to suppress proliferation in tumors driven by RAS/RAF/MEK/ERK alterations. It has shown clinical activity in MEK-dependent tumors (e.g., BRAF-mutant melanoma in combination with BRAF inhibition) and is being tested here to enhance chemotherapy efficacy in MAPK-altered biliary cancers. Known class toxicities include rash, diarrhea, edema, CPK elevation, ocular events (including RVO risk), and cardiomyopathy, warranting ocular and cardiac monitoring.

Outcomes: Primary: overall survival. Secondary: objective response rate, progression-free survival, duration of response, clinical benefit rate, and safety/tolerability (CTCAE v5.0). Exploratory: development of a prognostic model (clinical and molecular features), correlation of outcomes with albumin and MAPK alterations, serial ctDNA (allelic burden changes), whole-exome and RNA sequencing for response/resistance mechanisms, and validation of a machine-learning algorithm for MAPK mutation detection and outcome prediction.

Burden on patient: Moderate to high. Patients receive biweekly infusional chemotherapy with a 46–48-hour 5-FU pump and additional oral binimetinib in the experimental arm, requiring frequent clinic visits. Required baseline and on-treatment imaging (CT/MRI, occasionally FDG-PET), blood draws, and mandated pre-treatment tissue (archival within 12 months or new biopsy) add procedures beyond standard care. The experimental arm includes baseline cardiac (ECHO or MUGA) assessments and ongoing monitoring due to MEK inhibitor risks, plus ophthalmologic vigilance for RVO or other ocular toxicities. While procedures align with typical second-line BTC management, the added oral agent, potential biopsies, and intensified safety monitoring increase visit frequency and time commitment, as well as risks of ocular, cardiac, dermatologic, gastrointestinal, and CPK-related adverse events.

Eligibility

Show Criteria

Inclusion 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

Sites (208)

Sort by distance to:

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

[email protected] / 205-934-0220

Status: Recruiting

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

[email protected] / 251-445-9870

Status: Recruiting

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

No email / No phone

Status: Active, not recruiting

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

[email protected] / 858-822-5354

Status: Recruiting

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

No email / 310-423-8965

Status: Recruiting

Presbyterian Intercommunity Hospital

Whittier, California, 90602, United States

No email / 562-698-0811

Status: Recruiting

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States

No email / 954-461-2180

Status: Recruiting

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

No email / 305-243-2647

Status: Recruiting

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

No email / 305-243-2647

Status: Recruiting

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States

[email protected] / 352-273-8010

Status: Recruiting

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

No email / 855-776-0015

Status: Recruiting

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

No email / 305-243-2647

Status: Recruiting

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States

No email / 305-243-2647

Status: Recruiting

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States

No email / 305-243-2647

Status: Recruiting

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

[email protected] / 808-524-6115

Status: Recruiting

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States

No email / No phone

Status: SUSPENDED

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

No email / 808-545-8548

Status: Recruiting

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States

No email / 808-531-8521

Status: Recruiting

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States

[email protected] / 808-539-2273

Status: Recruiting

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, 96706, United States

[email protected] / No phone

Status: Recruiting

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

[email protected] / 734-712-3671

Status: Recruiting

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

[email protected] / 208-381-2774

Status: Recruiting

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

[email protected] / 734-712-3671

Status: Recruiting

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

[email protected] / 406-969-6060

Status: Recruiting

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States

[email protected] / 208-381-2774

Status: Recruiting

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

[email protected] / 208-381-2774

Status: Recruiting

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

[email protected] / 406-969-6060

Status: Recruiting

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

[email protected] / 208-381-2774

Status: Recruiting

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

[email protected] / 406-969-6060

Status: Recruiting

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States

[email protected] / 406-969-6060

Status: Recruiting

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States

No email / 847-842-4847

Status: Recruiting

Northwestern University

Chicago, Illinois, 60611, United States

[email protected] / 312-695-1301

Status: Recruiting

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

No email / 312-864-5204

Status: Recruiting

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

[email protected] / 773-702-8222

Status: Recruiting

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

No email / 773-296-5360

Status: Recruiting

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014, United States

[email protected] / 630-929-6129

Status: Recruiting

Carle at The Riverfront

Danville, Illinois, 61832, United States

[email protected] / 800-446-5532

Status: Recruiting

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

[email protected] / 217-876-4762

Status: Recruiting

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

[email protected] / 217-876-4762

Status: Recruiting

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

[email protected] / 630-352-5360

Status: Recruiting

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

[email protected] / 630-275-1270

Status: Recruiting

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

[email protected] / 800-446-5532

Status: Recruiting

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

[email protected] / 217-876-4762

Status: Recruiting

Advocate Sherman Hospital

Elgin, Illinois, 60123, United States

No email / 847-429-2907

Status: Recruiting

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

[email protected] / 630-352-5360

Status: Recruiting

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States

No email / 312-695-1102

Status: Recruiting

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States

No email / 312-695-1102

Status: Recruiting

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429, United States

No email / 708-799-9995

Status: Recruiting

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

[email protected] / No phone

Status: Recruiting

AMG Libertyville - Oncology

Libertyville, Illinois, 60048, United States

[email protected] / 630-929-6129

Status: Recruiting

Condell Memorial Hospital

Libertyville, Illinois, 60048, United States

[email protected] / 630-929-6129

Status: Recruiting

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

[email protected] / 800-446-5532

Status: Recruiting

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States

[email protected] / 773-702-8222

Status: Recruiting

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

[email protected] / 217-876-4762

Status: Recruiting

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699, United States

No email / 800-323-8622

Status: Recruiting

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

[email protected] / No phone

Status: Recruiting

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States

[email protected] / 773-702-8222

Status: Recruiting

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

No email / 847-384-3621

Status: Recruiting

Memorial Hospital East

Shiloh, Illinois, 62269, United States

[email protected] / 314-747-9912

Status: Recruiting

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

No email / 217-545-7929

Status: Recruiting

Springfield Clinic

Springfield, Illinois, 62702, United States

No email / 800-444-7541

Status: Recruiting

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

[email protected] / 217-528-7541

Status: Recruiting

Carle Cancer Center

Urbana, Illinois, 61801, United States

[email protected] / 800-446-5532

Status: Recruiting

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

[email protected] / 630-352-5360

Status: Recruiting

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

No email / 515-241-3305

Status: Recruiting

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

No email / 515-241-3305

Status: Recruiting

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

No email / 515-241-3305

Status: Recruiting

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

No email / 859-257-3379

Status: Recruiting

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412, United States

No email / 800-987-3005

Status: Recruiting

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

No email / 800-888-8823

Status: Recruiting

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

No email / 301-319-2100

Status: Recruiting

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

No email / 800-411-1222

Status: Recruiting

UPMC Western Maryland

Cumberland, Maryland, 21502, United States

No email / 240-964-1400

Status: Recruiting

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

[email protected] / 734-712-7251

Status: Recruiting

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

[email protected] / No phone

Status: Recruiting

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States

[email protected] / 734-712-7251

Status: Recruiting

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States

[email protected] / 734-712-7251

Status: Recruiting

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116, United States

No email / 800-865-1125

Status: Recruiting

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States

[email protected] / 734-712-7251

Status: Recruiting

Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States

[email protected] / 734-712-7251

Status: Recruiting

Chelsea Hospital

Chelsea, Michigan, 48118, United States

[email protected] / 734-712-7251

Status: Recruiting

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States

[email protected] / 734-712-7251

Status: Recruiting

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States

No email / 248-551-7695

Status: Recruiting

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, 48336, United States

No email / 248-551-7695

Status: Recruiting

Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States

[email protected] / 810-762-8038

Status: Recruiting

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

[email protected] / 810-762-8038

Status: Recruiting

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

[email protected] / 810-762-8038

Status: Recruiting

Hurley Medical Center

Flint, Michigan, 48503, United States

[email protected] / 810-762-8038

Status: Recruiting

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

[email protected] / 517-364-3712

Status: Recruiting

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

[email protected] / 734-712-7251

Status: Recruiting

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States

[email protected] / 313-343-3166

Status: Recruiting

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

[email protected] / 734-712-7251

Status: Recruiting

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

No email / 248-551-7695

Status: Recruiting

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085, United States

No email / 248-551-7695

Status: Recruiting

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States

[email protected] / 734-712-7251

Status: Recruiting

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

[email protected] / 734-712-7251

Status: Recruiting

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

[email protected] / 218-333-5000

Status: Recruiting

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

[email protected] / 952-993-1517

Status: Recruiting

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States

[email protected] / 218-786-3308

Status: Recruiting

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

[email protected] / 218-786-3308

Status: Recruiting

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

[email protected] / 952-993-1517

Status: Recruiting

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

No email / 218-786-3308

Status: Recruiting

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

[email protected] / 952-993-1517

Status: Recruiting

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

[email protected] / 952-993-1517

Status: Recruiting

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

No email / 855-776-0015

Status: Recruiting

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

[email protected] / 952-993-1517

Status: Recruiting

Regions Hospital

Saint Paul, Minnesota, 55101, United States

[email protected] / 952-993-1517

Status: Recruiting

United Hospital

Saint Paul, Minnesota, 55102, United States

[email protected] / 952-993-1517

Status: Recruiting

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

[email protected] / 218-786-3308

Status: Recruiting

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

[email protected] / 218-786-3308

Status: Recruiting

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705, United States

[email protected] / 901-226-1366

Status: Recruiting

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901, United States

[email protected] / 901-226-1366

Status: Recruiting

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652, United States

[email protected] / 901-226-1366

Status: Recruiting

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655, United States

[email protected] / 901-226-1366

Status: Recruiting

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

[email protected] / 901-226-1366

Status: Recruiting

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

[email protected] / 573-334-2230

Status: Recruiting

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

[email protected] / 800-600-3606

Status: Recruiting

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

[email protected] / 800-600-3606

Status: Recruiting

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

No email / 314-996-5569

Status: Recruiting

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

No email / 314-996-5569

Status: Recruiting

Washington University School of Medicine

St Louis, Missouri, 63110, United States

[email protected] / 800-600-3606

Status: Recruiting

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

[email protected] / 800-600-3606

Status: Recruiting

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

No email / 314-996-5569

Status: Recruiting

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States

[email protected] / 800-600-3606

Status: Recruiting

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

No email / 314-996-5569

Status: Recruiting

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

No email / 314-996-5569

Status: Recruiting

Community Hospital of Anaconda

Anaconda, Montana, 59711, United States

No email / No phone

Status: SUSPENDED

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

[email protected] / 800-996-2663

Status: Recruiting

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

[email protected] / 406-969-6060

Status: Recruiting

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

[email protected] / 406-969-6060

Status: Recruiting

Logan Health Medical Center

Kalispell, Montana, 59901, United States

[email protected] / 406-969-6060

Status: Recruiting

Community Medical Center

Missoula, Montana, 59804, United States

[email protected] / 406-969-6060

Status: Recruiting

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States

[email protected] / 402-559-6941

Status: Recruiting

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

No email / 402-559-5600

Status: Recruiting

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

[email protected] / 402-559-6941

Status: Recruiting

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052, United States

[email protected] / 702-384-0013

Status: Recruiting

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102, United States

[email protected] / 702-384-0013

Status: Recruiting

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148, United States

[email protected] / 702-384-0013

Status: Recruiting

Renown Regional Medical Center

Reno, Nevada, 89502, United States

[email protected] / 702-384-0013

Status: Recruiting

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

[email protected] / 505-925-0348

Status: Recruiting

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

[email protected] / 800-767-9355

Status: Recruiting

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

[email protected] / 701-323-5760

Status: Recruiting

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

[email protected] / 701-323-5760

Status: Recruiting

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

[email protected] / 701-234-6161

Status: Recruiting

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

[email protected] / 937-528-2900

Status: Recruiting

Miami Valley Hospital

Dayton, Ohio, 45409, United States

[email protected] / 937-528-2900

Status: Recruiting

Premier Blood and Cancer Center

Dayton, Ohio, 45409, United States

No email / 937-276-8320

Status: Recruiting

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415, United States

No email / No phone

Status: SUSPENDED

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

[email protected] / 937-528-2900

Status: Recruiting

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

[email protected] / 937-528-2900

Status: Recruiting

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331, United States

No email / 937-569-7515

Status: Recruiting

Kettering Medical Center

Kettering, Ohio, 45429, United States

No email / No phone

Status: SUSPENDED

Upper Valley Medical Center

Troy, Ohio, 45373, United States

[email protected] / 937-528-2900

Status: Recruiting

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

[email protected] / 405-271-8777

Status: Recruiting

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914, United States

[email protected] / 406-969-6060

Status: Recruiting

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

[email protected] / 610-402-9543

Status: Recruiting

UPMC Altoona

Altoona, Pennsylvania, 16601, United States

[email protected] / 773-702-9171

Status: Recruiting

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

[email protected] / 610-402-9543

Status: Recruiting

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

[email protected] / 610-402-9543

Status: Recruiting

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States

[email protected] / 412-389-5208

Status: Recruiting

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

No email / 724-838-1900

Status: Recruiting

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201, United States

[email protected] / 610-402-9543

Status: Recruiting

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050, United States

[email protected] / 412-389-5208

Status: Recruiting

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146, United States

[email protected] / 412-389-5208

Status: Recruiting

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

No email / 412-647-8073

Status: Recruiting

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

No email / 412-367-6454

Status: Recruiting

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

[email protected] / 605-312-3320

Status: Recruiting

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

[email protected] / 605-312-3320

Status: Recruiting

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017, United States

[email protected] / 901-226-1366

Status: Recruiting

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

[email protected] / 901-226-1366

Status: Recruiting

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

[email protected] / 866-632-6789

Status: Recruiting

M D Anderson Cancer Center

Houston, Texas, 77030, United States

[email protected] / 877-632-6789

Status: Recruiting

MD Anderson West Houston

Houston, Texas, 77079, United States

[email protected] / 877-632-6789

Status: Recruiting

MD Anderson League City

League City, Texas, 77573, United States

[email protected] / 877-632-6789

Status: Recruiting

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

[email protected] / 877-632-6789

Status: Recruiting

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

[email protected] / 434-243-6303

Status: Recruiting

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

[email protected] / 703-720-5210

Status: Recruiting

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

[email protected] / 703-208-6650

Status: Recruiting

Virginia Cancer Institute

Richmond, Virginia, 23229, United States

[email protected] / 804-287-3000

Status: Recruiting

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States

[email protected] / No phone

Status: Recruiting

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

[email protected] / 804-628-6430

Status: Recruiting

VCU Community Memorial Health Center

South Hill, Virginia, 23970, United States

[email protected] / No phone

Status: Recruiting

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States

[email protected] / 206-215-2343

Status: Recruiting

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States

[email protected] / 206-215-2343

Status: Recruiting

Valley Medical Center

Renton, Washington, 98055, United States

[email protected] / 425-228-3440

Status: Recruiting

Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States

[email protected] / 206-215-2343

Status: Recruiting

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

[email protected] / 304-293-7374

Status: Recruiting

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

[email protected] / 920-364-3604

Status: Recruiting

Duluth Clinic Ashland

Ashland, Wisconsin, 54806, United States

[email protected] / 218-786-3308

Status: Recruiting

ThedaCare Cancer Care - Berlin

Berlin, Wisconsin, 54923, United States

[email protected] / 920-364-3605

Status: Recruiting

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

[email protected] / 414-302-2304

Status: Recruiting

ThedaCare Regional Medical Center - Neenah

Neenah, Wisconsin, 54956, United States

[email protected] / 920-364-3605

Status: Recruiting

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406, United States

[email protected] / 414-302-2304

Status: Recruiting

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

[email protected] / 414-302-2304

Status: Recruiting

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States

[email protected] / 414-302-2304

Status: Recruiting

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

[email protected] / 414-302-2304

Status: Recruiting

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

Trial Details

Show Summary from Sponsor

More details:

Investigational Drug AI Analysis

HealthScout AI Analysis

Eligibility

Show Criteria

Sites (208)

University of Alabama at Birmingham Cancer Center

University of South Alabama Mitchell Cancer Institute

Mayo Clinic Hospital in Arizona

UC San Diego Moores Cancer Center

Cedars Sinai Medical Center

Presbyterian Intercommunity Hospital

UM Sylvester Comprehensive Cancer Center at Aventura

UM Sylvester Comprehensive Cancer Center at Coral Gables

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

University of Florida Health Science Center - Gainesville

Mayo Clinic in Florida

University of Miami Miller School of Medicine-Sylvester Cancer Center

UM Sylvester Comprehensive Cancer Center at Kendall

UM Sylvester Comprehensive Cancer Center at Plantation

Hawaii Cancer Care Inc - Waterfront Plaza

Queen's Cancer Cenrer - POB I

Queen's Medical Center

Queen's Cancer Center - Kuakini

Hawaii Cancer Care - Westridge

The Queen's Medical Center - West Oahu

Saint Alphonsus Cancer Care Center-Boise

Saint Luke's Cancer Institute - Boise

Saint Alphonsus Cancer Care Center-Caldwell

Kootenai Health - Coeur d'Alene

Saint Luke's Cancer Institute - Fruitland

Saint Luke's Cancer Institute - Meridian

Saint Alphonsus Cancer Care Center-Nampa

Saint Luke's Cancer Institute - Nampa

Kootenai Clinic Cancer Services - Post Falls

Kootenai Clinic Cancer Services - Sandpoint

Advocate Good Shepherd Hospital

Northwestern University

John H Stroger Jr Hospital of Cook County

University of Chicago Comprehensive Cancer Center

Advocate Illinois Masonic Medical Center

AMG Crystal Lake - Oncology

Carle at The Riverfront

Cancer Care Specialists of Illinois - Decatur

Decatur Memorial Hospital

Northwestern Medicine Cancer Center Kishwaukee

Advocate Good Samaritan Hospital

Carle Physician Group-Effingham

Crossroads Cancer Center

Advocate Sherman Hospital

Northwestern Medicine Cancer Center Delnor

Northwestern Medicine Glenview Outpatient Center

Northwestern Medicine Grayslake Outpatient Center

Advocate South Suburban Hospital

Northwestern Medicine Lake Forest Hospital

AMG Libertyville - Oncology

Condell Memorial Hospital

Carle Physician Group-Mattoon/Charleston

UC Comprehensive Cancer Center at Silver Cross

Cancer Care Center of O'Fallon

Advocate Christ Medical Center

Northwestern Medicine Orland Park

University of Chicago Medicine-Orland Park

Advocate Lutheran General Hospital

Memorial Hospital East

Southern Illinois University School of Medicine

Springfield Clinic

Springfield Memorial Hospital

Carle Cancer Center

Northwestern Medicine Cancer Center Warrenville

UI Health Care Mission Cancer and Blood - Ankeny Clinic

UI Health Care Mission Cancer and Blood - Des Moines Clinic

UI Health Care Mission Cancer and Blood - Waukee Clinic

University of Kentucky/Markey Cancer Center

Lafayette Family Cancer Center-EMMC

University of Maryland/Greenebaum Cancer Center

Walter Reed National Military Medical Center