NCT05564377

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

Traducción pendiente · disponible pronto

Reclutando Fase 2

Descripción

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.

Criterios de Elegibilidad

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

Información del Ensayo

Número NCT NCT05564377

Estado Reclutando

Fase Fase 2

Inscripción 2900 participantes

Fecha de Inicio Abr 2023

Finalización Est. Jul 2030

Ubicaciones479

Puerto Rico (4)

Puerto Rico Hematology Oncology Group

Bayamón, 00961 Reclutando

Doctors Cancer Center

Manati, 00674 Reclutando

Centro Comprensivo de Cancer de UPR

San Juan, 00927 Reclutando

PROncology

San Juan, 00927 Reclutando

United States (475)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233 Reclutando

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688 Reclutando

Alaska Women's Cancer Care

Anchorage, Alaska, 99508 Reclutando

CTCA at Western Regional Medical Center

Goodyear, Arizona, 85338 Reclutando

Kingman Regional Medical Center

Kingman, Arizona, 86401 Reclutando

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054 Suspendido

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401 Reclutando

PCR Oncology

Arroyo Grande, California, 93420 Reclutando

Mercy Cancer Center - Carmichael

Carmichael, California, 95608 Reclutando

Mercy San Juan Medical Center

Carmichael, California, 95608 Reclutando

Epic Care-Dublin

Dublin, California, 94568 Activo, no reclutando

Mercy Cancer Center - Elk Grove

Elk Grove, California, 95758 Reclutando

UC San Diego Health System - Encinitas

Encinitas, California, 92024 Reclutando

UC San Diego Moores Cancer Center

La Jolla, California, 92093 Reclutando

Cedars-Sinai Medical Center

Los Angeles, California, 90048 Reclutando

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, 90025 Reclutando

Contra Costa Regional Medical Center

Martinez, California, 94553-3156 Activo, no reclutando

Children's Hospital of Orange County

Orange, California, 92868 Reclutando

Saint Joseph Hospital - Orange

Orange, California, 92868 Reclutando

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304 Reclutando

VA Palo Alto Health Care System

Palo Alto, California, 94304 Suspendido

Mercy Cancer Center - Rocklin

Rocklin, California, 95765 Reclutando

Mercy Cancer Center - Sacramento

Sacramento, California, 95816 Reclutando

Sharp Memorial Hospital

San Diego, California, 92123 Reclutando

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103 Reclutando

UCSF Medical Center-Mission Bay

San Francisco, California, 94158 Suspendido

Saint John's Cancer Institute

Santa Monica, California, 90404 Reclutando

Epic Care Cyberknife Center

Walnut Creek, California, 94597 Activo, no reclutando

Presbyterian Intercommunity Hospital

Whittier, California, 90602 Suspendido

Woodland Memorial Hospital

Woodland, California, 95695 Reclutando

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045 Reclutando

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528 Reclutando

Poudre Valley Hospital

Fort Collins, Colorado, 80524 Reclutando

UCHealth Greeley Hospital

Greeley, Colorado, 80631 Reclutando

Medical Center of the Rockies

Loveland, Colorado, 80538 Reclutando

Helen F Graham Cancer Center

Newark, Delaware, 19713 Reclutando

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713 Reclutando

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180 Reclutando

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146 Reclutando

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442 Reclutando

Broward Health Medical Center

Fort Lauderdale, Florida, 33316 Reclutando

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610 Reclutando

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980 Reclutando

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176 Reclutando

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136 Reclutando

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, 33181 Reclutando

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324 Reclutando

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, 30265 Activo, no reclutando

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701 Reclutando

Pali Momi Medical Center

‘Aiea, Hawaii, 96701 Reclutando

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, 96706 Reclutando

Hawaii Cancer Care Inc - Waterfront Plaza