RecruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year, 2 years, 5 years
  • Procedures mentioned: Biopsies, CT scans, Blood draws, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Assess the concordance of the central molecular characterization of the pre-treatment biopsy samples with the genetic readouts from the Designated Laboratories (DLs) for patients enrolled on the ComboMATCH treatment trials."
  • "To assess how the registration diagnostic tumor mutation profile and pre-treatment biopsy profile compare to the circulating tumor-derived deoxyribonucleic acid (ctDNA) mutation profile from plasma."
  • "Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as echocardiogram (ECHO) or multigated acquisition (MUGA), and computed tomography (CT) scans throughout the trial."
  • "Patients may undergo bone marrow aspiration or biopsy as clinically indicated."
  • "Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial."
  • "Patients also undergo a CT, magnetic resonance imaging (MRI), or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This screening study uses tumor gene tests to match patients to ComboMATCH trials of targeted cancer treatments. It is for people with solid tumors that have spread nearby or to other parts of the body and have grown after standard treatment, or have no standard treatment shown to help people live longer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have a solid tumor confirmed by a tissue test that has spread nearby or farther away, needs treatment, and can be measured.
  • Your cancer must have grown after at least one standard treatment that works throughout the body, or have no standard treatment shown to help people live longer.
  • You must meet a daily activity score: ECOG 0–2, or Lansky or Karnofsky at least 50%. These scales measure how well you can do daily tasks.
  • Your enrolling provider must think you may qualify for a ComboMATCH treatment trial. Each treatment trial has its own rules.
  • You must have tumor gene test results from a lab approved by the National Cancer Institute for this study.
  • If you are 18 or older and a tumor sample can be taken at low risk, you must be willing and able to have this done for research if you join a treatment trial.
  • If you are 18 or older and a new sample cannot be taken at low risk, you must have stored tumor tissue from the past 12 months. It must be in preserved blocks or slides, and no treatment since collection can have partly or fully shrunk the cancer under the study's response rules.
  • If you are under 18, you must have stored tumor tissue in preserved blocks or slides available for research if you join a treatment trial.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official 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

    Study sites (479)

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    FL

    • UM Sylvester Comprehensive Cancer Center at Aventura · Aventura, FL 33180Site Public Contact · Study contact · 954-461-2180Chukwuemeka (Emeka) V. Ikpeazu · Principal investigatorMore trials in Aventura
    • UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, FL 33146Site Public Contact · Study contact · 305-243-2647Chukwuemeka (Emeka) V. Ikpeazu · Principal investigatorMore trials in Coral Gables
    • UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, FL 33442Site Public Contact · Study contact · 305-243-2647Chukwuemeka (Emeka) V. Ikpeazu · Principal investigatorMore trials in Deerfield Beach
    • Broward Health Medical Center · Fort Lauderdale, FL 33316More trials in Fort Lauderdale
    • UF Health Cancer Institute - Gainesville · Gainesville, FL 32610Site Public Contact · Study contact · 352-273-8010 · cancer-center@ufl.eduThomas J. George · Principal investigatorMore trials in Gainesville
    • Mayo Clinic in Florida · Jacksonville, FL 32224-9980Site Public Contact · Study contact · 855-776-0015Aaron S. Mansfield · Principal investigatorMore trials in Jacksonville
    • University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL 33136Site Public Contact · Study contact · 305-243-2647Chukwuemeka (Emeka) V. Ikpeazu · Principal investigatorMore trials in Miami
    • UM Sylvester Comprehensive Cancer Center at Kendall · Miami, FL 33176Site Public Contact · Study contact · 305-243-2647Chukwuemeka (Emeka) V. Ikpeazu · Principal investigatorMore trials in Miami
    • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia · North Miami, FL 33181Site Public Contact · Study contact · kginnity@med.miami.eduChukwuemeka (Emeka) V. Ikpeazu · Principal investigatorMore trials in North Miami
    • UM Sylvester Comprehensive Cancer Center at Plantation · Plantation, FL 33324Site Public Contact · Study contact · 305-243-2647Chukwuemeka (Emeka) V. Ikpeazu · Principal investigatorMore trials in Plantation

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    IA

    • UI Health Care Mission Cancer and Blood - Ankeny Clinic · Ankeny, IA 50023Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Ankeny
    • Mercy Hospital · Cedar Rapids, IA 52403Site Public Contact · Study contact · 319-365-4673Deborah W. Wilbur · Principal investigatorMore trials in Cedar Rapids
    • Oncology Associates at Mercy Medical Center · Cedar Rapids, IA 52403Site Public Contact · Study contact · 319-363-2690Deborah W. Wilbur · Principal investigatorMore trials in Cedar Rapids
    • UI Health Care Mission Cancer and Blood - Des Moines Clinic · Des Moines, IA 50309Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Des Moines
    • Mercy Medical Center - Des Moines · Des Moines, IA 50314Site Public Contact · Study contact · 515-241-3305Richard L. Deming · Principal investigatorMore trials in Des Moines
    • UI Health Care Mission Cancer and Blood - Laurel Clinic · Des Moines, IA 50314Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Des Moines
    • UI Health Care Mission Cancer and Blood - Waukee Clinic · Waukee, IA 50263Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Waukee

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