Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,900

participants targeted

Target at P75+ for phase_2

Timeline

50mo left

Started Apr 2023

Longer than P75 for phase_2

Geographic Reach

2 countries

479 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.2 years study duration

Study Progress43%

Apr 2023Jul 2030

First Submitted

Initial submission to the registry

September 27, 2022

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed

6 months until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed

7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

May 4, 2026

Status Verified

March 1, 2026

Enrollment Period

7.2 years

First QC Date

September 27, 2022

Last Update Submit

May 1, 2026

Conditions

Anatomic Stage III Breast Cancer AJCC v8 Unresectable Malignant Solid Neoplasm Advanced Malignant Solid Neoplasm Anatomic Stage IV Breast Cancer AJCC v8 Malignant Female Reproductive System Neoplasm Recurrent Fallopian Tube Carcinoma Unresectable HER2-Negative Breast Carcinoma Locally Advanced Malignant Solid Neoplasm Metastatic HER2-Negative Breast Carcinoma Metastatic Malignant Solid Neoplasm Recurrent Endometrial Carcinoma Recurrent Malignant Female Reproductive System Neoplasm Recurrent Malignant Solid Neoplasm Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (3)

Accrual of patients to ComboMATCH treatment trials
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
Up to 8 years
Assignment of patients to ComboMATCH treatment trials
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
Up to 8 years
Enrollment rates to ComboMATCH treatment trials
Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).
Up to 8 years

Secondary Outcomes (1)

Rate of positive outcomes within the treatment trial defined cohorts
Up to 8 years

Other Outcomes (1)

Concordance between whole exome sequencing (WES) and results from the Designated Laboratory (DL)
Up to 8 years

Study Arms (20)

EAY191-A2 (Cohort 1, Arm A)

EXPERIMENTAL

Cohort 1, Arm A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

Drug: AlpelisibProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: OlaparibProcedure: Positron Emission Tomography

EAY191-A2 (Cohort 2, Arm B)

EXPERIMENTAL

Cohort 2, Arm B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

EAY191-A2 (Cohort 2, Arm C)

EXPERIMENTAL

Cohort 2, Arm C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: OlaparibProcedure: Positron Emission Tomography

EAY191-A2 (Cohort 3, Arm D)

EXPERIMENTAL

Cohort 3, Arm D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

Drug: AlpelisibProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyDrug: OlaparibProcedure: Positron Emission Tomography

EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib)

EXPERIMENTAL

Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Palbociclib

EAY191-A3 Monotherapy Cohort 1 (binimetinib)

EXPERIMENTAL

Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

Drug: BinimetinibProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Magnetic Resonance Imaging

EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations)

EXPERIMENTAL

Patients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or a FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Echocardiography TestDrug: FluorouracilDrug: LeucovorinProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition ScanDrug: OxaliplatinProcedure: Positron Emission Tomography

EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)

EXPERIMENTAL

Patients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated

Drug: BinimetinibProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Echocardiography TestDrug: FluorouracilDrug: LeucovorinProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition ScanDrug: OxaliplatinProcedure: Positron Emission Tomography

EAY191-E4 (taxane therapy)

EXPERIMENTAL

Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Nilotinib Hydrochloride MonohydrateDrug: Paclitaxel

EAY191-E5 Cohort I Arm A (sotorasib, panitumumab)

EXPERIMENTAL

Patients receive sotorasib PO QD on days 1-28 and panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingBiological: PanitumumabDrug: Sotorasib

EAY191-E5 Cohort I Arm B (sotorasib)

ACTIVE COMPARATOR

Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Sotorasib

EAY191-E5 Cohort II (sotorasib)

EXPERIMENTAL

Patients receive combination therapy as in EAY191-E5 Arm A.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingBiological: PanitumumabDrug: Sotorasib

EAY191-N2 Cohort I (Arm I) (NF1 mutations)

EXPERIMENTAL

Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.

Drug: BinimetinibProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Echocardiography TestDrug: FulvestrantProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition Scan

EAY191-N2 Cohort I (Arm II) (NF1 mutations)

EXPERIMENTAL

Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Echocardiography TestDrug: FulvestrantProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition Scan

EAY191-N2 Cohort II (NF1 mutations)

EXPERIMENTAL

Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.

EAY191-N4 Arm I (RAS pathway mutations)

EXPERIMENTAL

Patients receive selumetinib PO BID and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 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 may undergo bone marrow aspiration or biopsy as clinically indicated.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanProcedure: Mutation Carrier ScreeningDrug: OlaparibDrug: Selumetinib Sulfate

EAY191-N4 Arm II (RAS pathway mutations)

ACTIVE COMPARATOR

Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. 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 may undergo bone marrow aspiration or biopsy as clinically indicated.

EAY191-N5 Arm I (neratinib maleate)

ACTIVE COMPARATOR

Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Echocardiography TestProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition ScanDrug: Neratinib Maleate

EAY191-N5 Arm II (neratinib maleate,palbociclib)

EXPERIMENTAL

Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

EAY191-S3 (activating AKT mutation)

EXPERIMENTAL

Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyDrug: IpatasertibProcedure: Magnetic Resonance ImagingDrug: Paclitaxel

Interventions

Biopsy ProcedurePROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

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)

Biospecimen CollectionPROCEDURE

Undergo blood collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

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)

Bone ScanPROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

IpatasertibDRUG

Given PO

Also known as: GDC 0068, GDC-0068, GDC0068, RG 7440, RG-7440, RG7440

EAY191-S3 (activating AKT mutation)

LeucovorinDRUG

Given IV

Also known as: Folinic acid

EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations)EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)

Multigated Acquisition ScanPROCEDURE

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

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)

Neratinib MaleateDRUG

Given PO

Also known as: 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, Nerlynx

EAY191-N5 Arm I (neratinib maleate)EAY191-N5 Arm II (neratinib maleate,palbociclib)

OlaparibDRUG

Given PO

Also known as: AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281

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)

SotorasibDRUG

Given PO

Also known as: AMG 510, AMG-510, AMG510, Lumakras, Lumykras

EAY191-E5 Cohort I Arm A (sotorasib, panitumumab)EAY191-E5 Cohort I Arm B (sotorasib)EAY191-E5 Cohort II (sotorasib)

Mutation Carrier ScreeningPROCEDURE

Undergo tumor mutational screening

EAY191-N4 Arm I (RAS pathway mutations)EAY191-N4 Arm II (RAS pathway mutations)

Positron Emission TomographyPROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

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)

FluorouracilDRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations)EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)

FulvestrantDRUG

Given IM

Also known as: Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780, ICI-182780, ICI182780, ZD 9238, ZD-9238, ZD9238

EAY191-N2 Cohort I (Arm I) (NF1 mutations)EAY191-N2 Cohort I (Arm II) (NF1 mutations)EAY191-N2 Cohort II (NF1 mutations)

Selumetinib SulfateDRUG

Given PO

Also known as: AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, Koselugo, Selumetinib Sulphate

EAY191-N4 Arm I (RAS pathway mutations)EAY191-N4 Arm II (RAS pathway mutations)

AlpelisibDRUG

Given PO

Also known as: BYL 719, BYL-719, BYL719, Phosphoinositide 3-kinase Inhibitor BYL719, Piqray, VIJOICE

EAY191-A2 (Cohort 1, Arm A)EAY191-A2 (Cohort 2, Arm B)EAY191-A2 (Cohort 3, Arm D)

BinimetinibDRUG

Given PO

Also known as: ARRY 162, ARRY 438162, ARRY-162, ARRY-438162, ARRY162, ARRY438162, MEK 162, MEK-162, MEK162, Mektovi

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)

Bone Marrow AspirationPROCEDURE

Undergo bone marrow aspiration

EAY191-N4 Arm I (RAS pathway mutations)EAY191-N4 Arm II (RAS pathway mutations)

Echocardiography TestPROCEDURE

Undergo ECHO

Also known as: EC, Echocardiography

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

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)

PaclitaxelDRUG

Given PO or IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

EAY191-E4 (taxane therapy)EAY191-S3 (activating AKT mutation)

PalbociclibDRUG

Given PO

Also known as: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, PD0332991

EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib)EAY191-N5 Arm II (neratinib maleate,palbociclib)

OxaliplatinDRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, Elplat, JM 83, JM-83, JM83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, RP54780, SR 96669, SR-96669, SR96669

EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations)EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)

Bone Marrow BiopsyPROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

EAY191-N4 Arm I (RAS pathway mutations)EAY191-N4 Arm II (RAS pathway mutations)

Computed TomographyPROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

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)

Nilotinib Hydrochloride MonohydrateDRUG

Given PO

Also known as: AMN 107, AMN-107, AMN107, Nilotinib Monohydrochloride Monohydrate, Tasigna

EAY191-E4 (taxane therapy)

PanitumumabBIOLOGICAL

Given IV

Also known as: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, E7.6.3, Human IgG2K Monoclonal Antibody, MoAb ABX-EGF, MoAb E7.6.3, Monoclonal Antibody ABX-EGF, Monoclonal Antibody E7.6.3, Vectibix

EAY191-E5 Cohort I Arm A (sotorasib, panitumumab)EAY191-E5 Cohort II (sotorasib)

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (479)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

RECRUITING

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

RECRUITING

Alaska Women's Cancer Care

Anchorage, Alaska, 99508, United States

RECRUITING

CTCA at Western Regional Medical Center

Goodyear, Arizona, 85338, United States

RECRUITING

Kingman Regional Medical Center

Kingman, Arizona, 86401, United States

RECRUITING

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

SUSPENDED

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

RECRUITING

PCR Oncology

Arroyo Grande, California, 93420, United States

RECRUITING

Mercy Cancer Center - Carmichael

Carmichael, California, 95608, United States

RECRUITING

Mercy San Juan Medical Center

Carmichael, California, 95608, United States

RECRUITING

Epic Care-Dublin

Dublin, California, 94568, United States

ACTIVE NOT RECRUITING

Mercy Cancer Center - Elk Grove

Elk Grove, California, 95758, United States

RECRUITING

UC San Diego Health System - Encinitas

Encinitas, California, 92024, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, 90025, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

ACTIVE NOT RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

Saint Joseph Hospital - Orange

Orange, California, 92868, United States

RECRUITING

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

RECRUITING

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

SUSPENDED

Mercy Cancer Center - Rocklin

Rocklin, California, 95765, United States

RECRUITING

Mercy Cancer Center - Sacramento

Sacramento, California, 95816, United States

RECRUITING

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

RECRUITING

Sharp Memorial Hospital

San Diego, California, 92123, United States

RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

SUSPENDED

Saint John's Cancer Institute

Santa Monica, California, 90404, United States

RECRUITING

Epic Care Cyberknife Center

Walnut Creek, California, 94597, United States

ACTIVE NOT RECRUITING

Presbyterian Intercommunity Hospital

Whittier, California, 90602, United States

SUSPENDED

Woodland Memorial Hospital

Woodland, California, 95695, United States

RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States

RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, 80631, United States

RECRUITING

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

RECRUITING

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States

RECRUITING

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, 33181, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States

RECRUITING

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

ACTIVE NOT RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza