NCT05564377From ClinicalTrials.govRecruiting

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

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

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

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: National Cancer Institute (NCI)
Enrolment target: 2,900
Started: 7 April 2023
Main results due: 1 July 2030
Study sites: 482
Registry updated: 29 September 2026

Can you take part?

No age limit is stated.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(482)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Recruiting
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Recruiting
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
Recruiting
Kingman Regional Medical Center
Kingman, Arizona, United States
Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Suspended
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Recruiting
PCR Oncology
Arroyo Grande, California, United States
Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Recruiting
Mercy San Juan Medical Center
Carmichael, California, United States
Recruiting
Epic Care-Dublin
Dublin, California, United States
Active, not recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Recruiting
UC San Diego Health System - Encinitas
Encinitas, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Recruiting
Contra Costa Regional Medical Center
Martinez, California, United States
Active, not recruiting
Children's Hospital of Orange County
Orange, California, United States
Recruiting
Saint Joseph Hospital - Orange
Orange, California, United States
Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Recruiting
VA Palo Alto Health Care System
Palo Alto, California, United States
Recruiting
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California, United States
Recruiting
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Recruiting
Sharp Memorial Hospital
San Diego, California, United States
Recruiting
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Suspended
Saint John's Cancer Institute
Santa Monica, California, United States
Recruiting
Epic Care Cyberknife Center
Walnut Creek, California, United States
Active, not recruiting
Presbyterian Intercommunity Hospital
Whittier, California, United States
Suspended
Woodland Memorial Hospital
Woodland, California, United States
Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, United States
Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
Recruiting
UCHealth Greeley Hospital
Greeley, Colorado, United States
Recruiting
Medical Center of the Rockies
Loveland, Colorado, United States
Recruiting
Helen F Graham Cancer Center
Newark, Delaware, United States
Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, United States
Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
Recruiting
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Recruiting
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, United States
Active, not recruiting
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Recruiting
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States
Recruiting
Queen's Medical Center
Honolulu, Hawaii, United States
Recruiting
Straub Clinic and Hospital
Honolulu, Hawaii, United States
Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Recruiting
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, United States
Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Recruiting

Showing 60 of 482 sites — filter to narrow it down. 431 of the 482 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05564377. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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