IRB Study Number 23-1048
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objectives
2.1.1 To register, allocate, and assign patients to ComboMATCH Treatment Trials.
Secondary Objectives
2.2.1 To evaluate the rate of positive outcomes in defined cohorts within treatment trials of treatment combinations including targeted therapies for molecularly defined populations, and also in the subset of treatment trials where the treatments are supported by in vivo models.
2.2.2 To perform quality control of the patients registered in the form of pathological confirmation of disease and sub-type to confirm diagnosis and treatment arm allocation.
Inclusion Criteria
3.1.1 Patient must have measurable disease.
3.1.2 Patient must have an ECOG performance status between 0-2. OR
Patient must have Lansky performance status of ≥ 50% or Karnofsky performance status of ≥ 50%.
3.1.3 Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider.
3.1.4 All patients must have sequencing results available from an NCI credentialed Designated Laboratory (DL).
3.1.5 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.
3.1.6 Patient must meet one of the following requirements:
a. 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
b. 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 RECIST response (CR or PR) to any intervening therapy after collection of the tissue
Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available (see Section 5.3). OR
c. Patients under 18 years old must confirm willingness to submit an archival tumor tissue specimen, if available, for research if the 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 (see Section 5.3).
NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial 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 reevaluation and potential assignment to another Treatment Trial.
Exclusion Criteria
Exclusion Criteria Not Available
