NCT05564377
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
PHASE2
RECRUITING
NCT05564377
INTERVENTIONAL
Molecular Analysis for Combination Therapy Choice (ComboMATCH)
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.
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
Advanced Malignant Solid Neoplasm
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Locally Advanced Malignant Solid Neoplasm
Malignant Female Reproductive System Neoplasm
Metastatic HER2-Negative Breast Carcinoma
Metastatic Malignant Solid Neoplasm
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Malignant Solid Neoplasm
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Unresectable HER2-Negative Breast Carcinoma
Unresectable Malignant Solid Neoplasm
- SCREENING
-
- Type: DRUG
- Name: Alpelisib
- Description: Given PO
- Arm Group Labels: EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 3, Arm D)
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- Type: DRUG
- Name: Binimetinib
- Description: Given PO
- Arm Group Labels: EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations)
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- Type: PROCEDURE
- Name: Biopsy
- Description: Undergo biopsy
- Arm Group Labels: EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-E4 (taxane therapy), EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib), EAY191-S3 (activating AKT mutation)
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- Type: PROCEDURE
- Name: Biospecimen Collection
- Description: Undergo blood collection
- Arm Group Labels: EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-E4 (taxane therapy), EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib), EAY191-S3 (activating AKT mutation)
-
- Type: PROCEDURE
- Name: Bone Marrow Aspiration
- Description: Undergo bone marrow aspiration
- Arm Group Labels: EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations)
-
- Type: PROCEDURE
- Name: Bone Scan
- Description: Undergo bone scan
- Arm Group Labels: EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations)
-
- Type: PROCEDURE
- Name: Computed Tomography
- Description: Undergo CT
- Arm Group Labels: EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-E4 (taxane therapy), EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib), EAY191-S3 (activating AKT mutation)
-
- Type: PROCEDURE
- Name: Echocardiography
- Description: Undergo ECHO
- Arm Group Labels: EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib)
-
- Type: DRUG
- Name: Fluorouracil
- Description: Given IV
- Arm Group Labels: EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)
-
- Type: DRUG
- Name: Fulvestrant
- Description: Given IM
- Arm Group Labels: EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations)
-
- Type: DRUG
- Name: Ipatasertib
- Description: Given PO
- Arm Group Labels: EAY191-S3 (activating AKT mutation)
-
- Type: DRUG
- Name: Leucovorin
- Description: Given IV
- Arm Group Labels: EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)
-
- Type: PROCEDURE
- Name: Magnetic Resonance Imaging
- Description: Undergo MRI
- Arm Group Labels: EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-A3 Monotherapy Cohort 1 (binimetinib), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-E4 (taxane therapy), EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib), EAY191-S3 (activating AKT mutation)
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- Type: PROCEDURE
- Name: Multigated Acquisition Scan
- Description: Undergo MUGA
- Arm Group Labels: EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations), EAY191-N2 Cohort I (Arm I) (NF1 mutations), EAY191-N2 Cohort I (Arm II) (NF1 mutations), EAY191-N2 Cohort II (NF1 mutations), EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations), EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib)
-
- Type: PROCEDURE
- Name: Mutation Carrier Screening
- Description: Undergo tumor mutational screening
- Arm Group Labels: EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations)
-
- Type: DRUG
- Name: Neratinib Maleate
- Description: Given PO
- Arm Group Labels: EAY191-N5 Arm I (neratinib maleate), EAY191-N5 Arm II (neratinib maleate,palbociclib)
-
- Type: DRUG
- Name: Nilotinib Hydrochloride Monohydrate
- Description: Given PO
- Arm Group Labels: EAY191-E4 (taxane therapy)
-
- Type: DRUG
- Name: Olaparib
- Description: Given PO
- Arm Group Labels: EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-N4 Arm I (RAS pathway mutations)
-
- Type: DRUG
- Name: Oxaliplatin
- Description: Given IV
- Arm Group Labels: EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)
-
- Type: DRUG
- Name: Paclitaxel
- Description: Given PO or IV
- Arm Group Labels: EAY191-E4 (taxane therapy), EAY191-S3 (activating AKT mutation)
-
- Type: DRUG
- Name: Palbociclib
- Description: Given PO
- Arm Group Labels: EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib), EAY191-N5 Arm II (neratinib maleate,palbociclib)
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- Type: BIOLOGICAL
- Name: Panitumumab
- Description: Given IV
- Arm Group Labels: EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort II (sotorasib)
-
- Type: PROCEDURE
- Name: Positron Emission Tomography
- Description: Undergo PET
- Arm Group Labels: EAY191-A2 (Cohort 1, Arm A), EAY191-A2 (Cohort 2, Arm B), EAY191-A2 (Cohort 2, Arm C), EAY191-A2 (Cohort 3, Arm D), EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations), EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)
-
- Type: DRUG
- Name: Selumetinib Sulfate
- Description: Given PO
- Arm Group Labels: EAY191-N4 Arm I (RAS pathway mutations), EAY191-N4 Arm II (RAS pathway mutations)
-
- Type: DRUG
- Name: Sotorasib
- Description: Given PO
- Arm Group Labels: EAY191-E5 Cohort I Arm A (sotorasib, panitumumab), EAY191-E5 Cohort I Arm B (sotorasib), EAY191-E5 Cohort II (sotorasib)
- National Cancer Institute (NCI)