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

Overview

About this study

This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. P

atients 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/21/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vinicius Ernani, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20564177

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