Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Recruiting · NCT05564377 · Interventional (participants receive a specific treatment) · Lead sponsor: National Cancer Institute (NCI)
View the official record on ClinicalTrials.gov →Interventions studied
AlpelisibBinimetinibBiopsy ProcedureBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyBone ScanComputed TomographyEchocardiography TestFluorouracilFulvestrantIpatasertibLeucovorinMagnetic Resonance ImagingMultigated Acquisition ScanMutation Carrier ScreeningNeratinib MaleateNilotinib Hydrochloride MonohydrateOlaparibOxaliplatinPaclitaxelPalbociclibPanitumumabPositron Emission TomographySelumetinib SulfateSotorasib
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 44 US states.
- 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 - Honolulu, Hawaii, United States
- Queen's Cancer Cenrer - POB I - Honolulu, Hawaii, United States
- Queen's Medical Center - Honolulu, Hawaii, United States
- Straub Clinic and Hospital - Honolulu, Hawaii, United States
- University of Hawaii Cancer Center - Honolulu, Hawaii, United States
- Queen's Cancer Center - Kuakini - Honolulu, Hawaii, United States
- Kapiolani Medical Center for Women and Children - Honolulu, Hawaii, United States
- Hawaii Cancer Care - Westridge - ‘Aiea, Hawaii, United States
- Pali Momi Medical Center - ‘Aiea, Hawaii, United States
- The Queen's Medical Center - West Oahu - ‘Ewa Beach, Hawaii, United States
- Saint Alphonsus Cancer Care Center-Boise - Boise, Idaho, United States
- Saint Luke's Cancer Institute - Boise - Boise, Idaho, United States
Showing 60 of 482 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →