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RECRUITING

NCT05564377

PHASE2

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

Official title: Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

2900

Start Date

2023-04-07

Completion Date

2030-07-01

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Advanced Malignant Solid Neoplasm Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Locally Advanced Malignant Solid Neoplasm Malignant Female Reproductive System Neoplasm Metastatic HER2-Negative Breast Carcinoma Metastatic Malignant Solid Neoplasm Recurrent Endometrial Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Malignant Female Reproductive System Neoplasm Recurrent Malignant Solid Neoplasm Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Unresectable HER2-Negative Breast Carcinoma Unresectable Malignant Solid Neoplasm

Interventions

DRUG

Alpelisib

Given PO

DRUG

Binimetinib

Given PO

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fluorouracil

Given IV

DRUG

Fulvestrant

Given IM

DRUG

Ipatasertib

Given PO

DRUG

Leucovorin

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Mutation Carrier Screening

Undergo tumor mutational screening

DRUG

Neratinib Maleate

Given PO

DRUG

Nilotinib Hydrochloride Monohydrate

Given PO

DRUG

Olaparib

Given PO

DRUG

Oxaliplatin

Given IV

DRUG

Paclitaxel

Given PO or IV

DRUG

Palbociclib

Given PO

BIOLOGICAL

Panitumumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

DRUG

Selumetinib Sulfate

Given PO

DRUG

Sotorasib

Given PO

Inclusion Criteria: * Patient must have measurable disease * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>= 50% or Karnofsky performance status of \>= 50% * Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider * All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL) * Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria: * Patients must have progressed on at least one line of standard systemic therapy OR * Patients whose disease has no standard treatment that has been shown to prolong overall survival * Patient must meet one of the following requirements: * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria: * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial * Patient must not have 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 * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria: * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only * NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial

Locations (480)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

PCR Oncology

Arroyo Grande, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Epic Care-Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

UC San Diego Health System - Encinitas

Encinitas, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Children's Hospital of Orange County

Orange, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Sharp Memorial Hospital

San Diego, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Saint John's Cancer Institute

Santa Monica, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

Presbyterian Intercommunity Hospital

Whittier, California, United States

Woodland Memorial Hospital

Woodland, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza