This study is currently recruiting participants.
Number
001665-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 2 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Precision Medicine; Combination Therapy; mutation of interest
Recruitment Keyword(s)
Condition(s)
Solid Tumors; Cancer
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
Finding the best drugs to treat cancer is the goal of many studies. Some drugs that are now under study target cancers with specific genetic changes. A set of treatment trials called ComboMATCH aims to find out if some of these drugs might work better together, in combination, rather than individually. Researchers want to find people with cancers that would make them good candidates for these trials.
Objective:
To enroll people in ComboMATCH cancer treatment trials.
Eligibility:
People aged 18 years and older who have cancer with specific genetic changes. The cancer must have no standard therapy; it may also have become worse after treatment.
Design:
Participants will have genetic tests of their tumors. If they have a genetic change that is a target of one or more of the study drugs, they will be invited to enroll in a treatment trial.
Participants will stop their current cancer treatment.
They will have a new biopsy of their tumor: A small sample of tissue will be cut away for testing. This will be done before they start the new treatment.
Participants will receive the study drugs; their treatment schedule will depend on which trial they enter. They will have blood tests and other exams during treatment.
Participants will receive study drugs until their cancer gets worse or they develop serious side effects.
After treatment ends, participants may have another biopsy as well as blood tests. Some participants may be eligible to enroll in a second trial.
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ELIGIBILITY CRITERIA SCREENING: - Patient must have measurable disease. - 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%. - 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 an 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: 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. 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. 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.
- Patient must have measurable disease.
- 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%.
- 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 an 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.
--Patients whose disease has no standard treatment that has been shown to prolong overall survival.
- 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.
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.
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.
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.
Principal Investigator
Referral Contact
For more information: