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Trial record 1 of 1 for:    02465060
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02465060
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : May 16, 2023
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Neoplasm Bladder Carcinoma Breast Carcinoma Cervical Carcinoma Colon Carcinoma Colorectal Carcinoma Endometrial Carcinoma Esophageal Carcinoma Gastric Carcinoma Glioma Head and Neck Carcinoma Kidney Carcinoma Liver and Intrahepatic Bile Duct Carcinoma Lung Carcinoma Lymphoma Malignant Uterine Neoplasm Melanoma Ovarian Carcinoma Pancreatic Carcinoma Plasma Cell Myeloma Prostate Carcinoma Rectal Carcinoma Recurrent Bladder Carcinoma Recurrent Breast Carcinoma Recurrent Cervical Carcinoma Recurrent Colon Carcinoma Recurrent Colorectal Carcinoma Recurrent Esophageal Carcinoma Recurrent Gastric Carcinoma Recurrent Glioma Recurrent Head and Neck Carcinoma Recurrent Liver Carcinoma Recurrent Lung Carcinoma Recurrent Lymphoma Recurrent Malignant Solid Neoplasm Recurrent Melanoma Recurrent Ovarian Carcinoma Recurrent Pancreatic Carcinoma Recurrent Plasma Cell Myeloma Recurrent Prostate Carcinoma Recurrent Rectal Carcinoma Recurrent Skin Carcinoma Recurrent Thyroid Gland Carcinoma Recurrent Uterine Corpus Cancer Refractory Lymphoma Refractory Malignant Solid Neoplasm Refractory Plasma Cell Myeloma Skin Carcinoma Thyroid Gland Carcinoma Uterine Corpus Cancer Drug: Adavosertib Drug: Afatinib Drug: Afatinib Dimaleate Drug: Binimetinib Procedure: Biopsy Drug: Capivasertib Procedure: Computed Tomography Drug: Copanlisib Drug: Copanlisib Hydrochloride Drug: Crizotinib Other: Cytology Specimen Collection Procedure Drug: Dabrafenib Drug: Dabrafenib Mesylate Drug: Dasatinib Drug: Defactinib Drug: Defactinib Hydrochloride Drug: Erdafitinib Drug: FGFR Inhibitor AZD4547 Drug: Ipatasertib Other: Laboratory Biomarker Analysis Drug: Larotrectinib Drug: Larotrectinib Sulfate Procedure: Magnetic Resonance Imaging Biological: Nivolumab Drug: Osimertinib Drug: Palbociclib Biological: Pertuzumab Drug: PI3K-beta Inhibitor GSK2636771 Biological: Relatlimab Drug: Sapanisertib Drug: Sunitinib Malate Drug: Taselisib Drug: Trametinib Biological: Trastuzumab Biological: Trastuzumab Emtansine Drug: Ulixertinib Drug: Vismodegib Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.

II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.

IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.

OUTLINE:

STEP 0 (Screening): Patients undergo biopsy along with molecular characterization of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Consenting patients also undergo collection of blood samples for research purposes.

STEPS 1, 3, 5, 7 (Treatment): Patients are assigned to 1 of 38 treatment subprotocols based on molecularly-defined subgroup. (See Arms Section)

STEPS 2, 4, 6 (Screening): Patients experiencing disease progression on the prior Step treatment or who could not tolerate the assigned treatment undergo review of their previous biopsy results to determine if another treatment is available or undergo another biopsy. Patients may have a maximum of 2 screening biopsies and 2 treatments per biopsy.

STEP 8 (Optional Research): Consenting patients undergo end-of-treatment biopsy and collection of blood samples for research purposes.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.

Study Design
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6452 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Molecular Analysis for Therapy Choice (MATCH)
Actual Study Start Date : August 12, 2015
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Subprotocol A (EGFR activating mutation)
Patients with EGFR activating mutation receive afatinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Afatinib
Given PO
Other Names:
  • BIBW 2992
  • BIBW2992

Drug: Afatinib Dimaleate
Given PO
Other Names:
  • (2E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide bis(hydrogen (2Z)-but-2-enedioate)
  • BIBW 2992MA2
  • BIBW2992 MA2
  • Gilotrif

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol B (HER2 activating mutation)
Patients with HER2 activating mutation receive afatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Afatinib
Given PO
Other Names:
  • BIBW 2992
  • BIBW2992

Drug: Afatinib Dimaleate
Given PO
Other Names:
  • (2E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide bis(hydrogen (2Z)-but-2-enedioate)
  • BIBW 2992MA2
  • BIBW2992 MA2
  • Gilotrif

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol C1 (MET amplification)
Patients with MET amplification receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Crizotinib
Given PO
Other Names:
  • MET Tyrosine Kinase Inhibitor PF-02341066
  • PF-02341066
  • PF-2341066
  • Xalkori

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol C2 (MET exon 14 deletion/mutation)
Patients with MET exon 14 deletion or other mutations that disrupt exon 14 receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Crizotinib
Given PO
Other Names:
  • MET Tyrosine Kinase Inhibitor PF-02341066
  • PF-02341066
  • PF-2341066
  • Xalkori

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol E (EGFR T790M or rare activating mutation)
Patients with EGFR T790M or rare activating mutation receive osimertinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Osimertinib
Given PO
Other Names:
  • AZD-9291
  • AZD9291
  • Mereletinib
  • Tagrisso
Experimental: Subprotocol F (ALK translocation)
Patients with ALK translocation receive crizotinib PO twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Crizotinib
Given PO
Other Names:
  • MET Tyrosine Kinase Inhibitor PF-02341066
  • PF-02341066
  • PF-2341066
  • Xalkori

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol G (ROS1 translocation or inversion)
Patients with ROS1 translocation or inversion receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Crizotinib
Given PO
Other Names:
  • MET Tyrosine Kinase Inhibitor PF-02341066
  • PF-02341066
  • PF-2341066
  • Xalkori

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol H (BRAF V600E/R/K/D mutation)
Patients with BRAF V600E/R/K/D mutation receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Drug: Dabrafenib
Given PO
Other Names:
  • BRAF Inhibitor GSK2118436
  • GSK-2118436
  • GSK-2118436A
  • GSK2118436

Drug: Dabrafenib Mesylate
Given PO
Other Names:
  • Dabrafenib Methanesulfonate
  • GSK2118436 Methane Sulfonate Salt
  • GSK2118436B
  • Tafinlar

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Trametinib
Given PO
Other Names:
  • GSK1120212
  • JTP-74057
  • MEK Inhibitor GSK1120212
Experimental: Subprotocol I (PIK3CA mutation)
Patients with PIK3CA mutation without RAS mutation or PTEN loss receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Taselisib
Given PO
Other Names:
  • GDC-0032
  • RO5537381
Experimental: Subprotocol J (HER2 amplification >= 7 copy numbers)
Patients with HER2 amplification >= 7 copy numbers receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Biological: Pertuzumab
Given IV
Other Names:
  • 2C4
  • 2C4 Antibody
  • EG1206A
  • HLX11
  • HS627
  • MoAb 2C4
  • Monoclonal Antibody 2C4
  • Omnitarg
  • Perjeta
  • Pertuzumab Biosimilar EG1206A
  • Pertuzumab Biosimilar HLX11
  • Pertuzumab Biosimilar HS627
  • rhuMAb2C4
  • RO4368451

Biological: Trastuzumab
Given IV
Other Names:
  • ABP 980
  • ALT02
  • Anti-c-ERB-2
  • Anti-c-erbB2 Monoclonal Antibody
  • Anti-ERB-2
  • Anti-erbB-2
  • Anti-erbB2 Monoclonal Antibody
  • Anti-HER2/c-erbB2 Monoclonal Antibody
  • Anti-p185-HER2
  • c-erb-2 Monoclonal Antibody
  • HER2 Monoclonal Antibody
  • Herceptin
  • Herceptin Biosimilar PF-05280014
  • Herceptin Trastuzumab Biosimilar PF-05280014
  • Herzuma
  • Kanjinti
  • MoAb HER2
  • Monoclonal Antibody c-erb-2
  • Monoclonal Antibody HER2
  • Ogivri
  • Ontruzant
  • PF-05280014
  • rhuMAb HER2
  • RO0452317
  • SB3
  • Trastuzumab Biosimilar ABP 980
  • Trastuzumab Biosimilar ALT02
  • trastuzumab biosimilar EG12014
  • Trastuzumab Biosimilar HLX02
  • Trastuzumab Biosimilar PF-05280014
  • Trastuzumab Biosimilar SB3
  • Trastuzumab Biosimilar SIBP-01
  • Trastuzumab-anns
  • Trastuzumab-dkst
  • Trastuzumab-dttb
  • Trastuzumab-pkrb
  • Trastuzumab-qyyp
  • Trazimera

Biological: Trastuzumab Emtansine
Given IV
Other Names:
  • Ado Trastuzumab Emtansine
  • ADO-Trastuzumab Emtansine
  • Kadcyla
  • PRO132365
  • RO5304020
  • T-DM1
  • Trastuzumab-DM1
  • Trastuzumab-MCC-DM1
  • Trastuzumab-MCC-DM1 Antibody-Drug Conjugate
  • Trastuzumab-MCC-DM1 Immunoconjugate
Experimental: Subprotocol K1 (FGFR amplification)
Patients with FGFR amplification receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Drug: Erdafitinib
Given PO
Other Names:
  • Balversa
  • JNJ-42756493

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol K2 (FGFR mutation or fusion)
Patients with FGFR mutation or fusion receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Drug: Erdafitinib
Given PO
Other Names:
  • Balversa
  • JNJ-42756493

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol L (mTOR mutation)
Patients with mTOR mutation receive sapanisertib PO daily on days 1-28. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Sapanisertib
Given PO
Other Names:
  • INK-128
  • INK128
  • MLN-0128
  • MLN0128
  • TAK-228
Experimental: Subprotocol M (TSC1 or TSC2 mutation)
Patients with TSC1 or TSC2 mutation receive sapanisertib PO daily on days 1-28. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Sapanisertib
Given PO
Other Names:
  • INK-128
  • INK128
  • MLN-0128
  • MLN0128
  • TAK-228
Experimental: Subprotocol N (PTEN mutation or deletion and PTEN expression)
Patients with PTEN mutation or deletion and PTEN expression receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: PI3K-beta Inhibitor GSK2636771
Given PO
Other Names:
  • GSK-2636771
  • GSK2636771
Experimental: Subprotocol P (PTEN loss)
Patients with PTEN loss receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: PI3K-beta Inhibitor GSK2636771
Given PO
Other Names:
  • GSK-2636771
  • GSK2636771
Experimental: Subprotocol Q (HER2 amplification)
Patients with HER2 amplification receive trastuzumab emtansine intravenously (IV) over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Biological: Trastuzumab
Given IV
Other Names:
  • ABP 980
  • ALT02
  • Anti-c-ERB-2
  • Anti-c-erbB2 Monoclonal Antibody
  • Anti-ERB-2
  • Anti-erbB-2
  • Anti-erbB2 Monoclonal Antibody
  • Anti-HER2/c-erbB2 Monoclonal Antibody
  • Anti-p185-HER2
  • c-erb-2 Monoclonal Antibody
  • HER2 Monoclonal Antibody
  • Herceptin
  • Herceptin Biosimilar PF-05280014
  • Herceptin Trastuzumab Biosimilar PF-05280014
  • Herzuma
  • Kanjinti
  • MoAb HER2
  • Monoclonal Antibody c-erb-2
  • Monoclonal Antibody HER2
  • Ogivri
  • Ontruzant
  • PF-05280014
  • rhuMAb HER2
  • RO0452317
  • SB3
  • Trastuzumab Biosimilar ABP 980
  • Trastuzumab Biosimilar ALT02
  • trastuzumab biosimilar EG12014
  • Trastuzumab Biosimilar HLX02
  • Trastuzumab Biosimilar PF-05280014
  • Trastuzumab Biosimilar SB3
  • Trastuzumab Biosimilar SIBP-01
  • Trastuzumab-anns
  • Trastuzumab-dkst
  • Trastuzumab-dttb
  • Trastuzumab-pkrb
  • Trastuzumab-qyyp
  • Trazimera

Biological: Trastuzumab Emtansine
Given IV
Other Names:
  • Ado Trastuzumab Emtansine
  • ADO-Trastuzumab Emtansine
  • Kadcyla
  • PRO132365
  • RO5304020
  • T-DM1
  • Trastuzumab-DM1
  • Trastuzumab-MCC-DM1
  • Trastuzumab-MCC-DM1 Antibody-Drug Conjugate
  • Trastuzumab-MCC-DM1 Immunoconjugate
Experimental: Subprotocol R (BRAF fusion or BRAF non-V600 mutation)
Patients with BRAF fusion or BRAF non-V600 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Trametinib
Given PO
Other Names:
  • GSK1120212
  • JTP-74057
  • MEK Inhibitor GSK1120212
Experimental: Subprotocol S1 (NF1 mutation)
Patients with NF1 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Trametinib
Given PO
Other Names:
  • GSK1120212
  • JTP-74057
  • MEK Inhibitor GSK1120212
Experimental: Subprotocol S2 (GNAQ or GNA11 mutation)
Patients with GNAQ or GNA11 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Trametinib
Given PO
Other Names:
  • GSK1120212
  • JTP-74057
  • MEK Inhibitor GSK1120212
Experimental: Subprotocol T (SMO or PTCH1 mutation)
Patients with SMO or PTCH1 mutation receive vismodegib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Vismodegib
Given PO
Other Names:
  • Erivedge
  • GDC-0449
  • Hedgehog Antagonist GDC-0449
Experimental: Subprotocol U (NF2 inactivating mutation)
Patients with NF2 inactivating mutation receive defactinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Drug: Defactinib
Given PO

Drug: Defactinib Hydrochloride
Given PO
Other Names:
  • PF-04554878
  • VS-6063

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation)
Patients with cKIT exon 9, 11, 13, or 14 mutation receive sunitinib malate PO QD for 4 weeks. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Sunitinib Malate
Given PO
Other Names:
  • SU011248
  • SU11248
  • sunitinib
  • Sutent
Experimental: Subprotocol W (FGFR pathway aberrations)
Patients with FGFR1-3 mutation or translocation receive FGFR Inhibitor AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Drug: FGFR Inhibitor AZD4547
Given PO
Other Names:
  • ABSK-091
  • ABSK091
  • AZD4547
  • KB-74810

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol X (DDR2 S768R, I638F, or L239R mutation)
Patients with DDR2 S768R, I638F, or L239R mutation receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Dasatinib Hydrate
  • Dasatinib Monohydrate
  • Sprycel

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol Y (Akt mutation)
Patients with Akt mutation receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Capivasertib
Given PO
Other Name: AZD5363

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61)
Patients with NRAS mutation in codon 12, 13, or 61 receive binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Binimetinib
Given PO
Other Names:
  • ARRY-162
  • ARRY-438162
  • MEK162
  • Mektovi

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC)
Patients with CCND1, 2, or 3 amplification that have tumor Rb expression by IHC receive palbociclib PO QD for 21 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Palbociclib
Given PO
Other Names:
  • 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
Experimental: Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein)
Patients with CDK4 or CDK6 amplification and tumor Rb protein receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Palbociclib
Given PO
Other Names:
  • 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
Experimental: Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC)
Patients with mismatch repair deficiency (loss of MLH1 or MSH2 by IHC) receive nivolumab IV over 30 minutes on days 1 and 15 for 4 cycles and then on day 1 every 28 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • CMAB819
  • MDX-1106
  • NIVO
  • Nivolumab Biosimilar CMAB819
  • ONO-4538
  • Opdivo
Experimental: Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion)
Patients with NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Larotrectinib
Given PO
Other Names:
  • ARRY 470
  • LOXO 101
  • LOXO-101

Drug: Larotrectinib Sulfate
Given PO
Other Names:
  • ARRY 470 Sulfate
  • LOXO 101 Sulfate
  • LOXO-101 Sulfate
  • Vitrakvi
Experimental: Subprotocol Z1F (PIK3CA mutation)
Patients receive copanlisib 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 also undergo tumor biopsies at screening and end of treatment as well as CT or MRI at baseline and repeated every 2 cycles for the first 26 cycles then every 3 cycles thereafter until progressive disease or start of another MATCH treatment step.
 Procedure: Biopsy
Undergo tumor biopsy
Other Names:
  • BIOPSY_TYPE
  • Bx

Procedure: Computed Tomography
Undergo computed tomography (CT)
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: Copanlisib
Given IV
Other Names:
  • BAY 80-6946
  • PI3K Inhibitor BAY 80-6946

Drug: Copanlisib Hydrochloride
Given IV
Other Names:
  • 5-Pyrimidinecarboxamide, 2-Amino-N-(2,3-dihydro-7-methoxy-8-(3-(4-morpholinyl)propoxy)imidazo(1,2-C)quinazolin-5-yl)-, Hydrochloride (1:2)
  • Aliqopa
  • BAY 80-6946 Dihydrochloride
  • BAY-80-6946 Dihydrochloride
  • Copanlisib Dihydrochloride

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Procedure: Magnetic Resonance Imaging
Undergo magnetic resonance imaging (MRI)
Other Names:
  • Magnetic Resonance
  • Magnetic resonance imaging (procedure)
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Experimental: Subprotocol Z1G (PTEN loss)
Patients with PTEN loss receive copanlisib IV over 1 hour on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Copanlisib
Given IV
Other Names:
  • BAY 80-6946
  • PI3K Inhibitor BAY 80-6946

Drug: Copanlisib Hydrochloride
Given IV
Other Names:
  • 5-Pyrimidinecarboxamide, 2-Amino-N-(2,3-dihydro-7-methoxy-8-(3-(4-morpholinyl)propoxy)imidazo(1,2-C)quinazolin-5-yl)-, Hydrochloride (1:2)
  • Aliqopa
  • BAY 80-6946 Dihydrochloride
  • BAY-80-6946 Dihydrochloride
  • Copanlisib Dihydrochloride

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol Z1H (PTEN mutation)
Patients with PTEN mutation receive copanlisib IV over 1 hour on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: Copanlisib
Given IV
Other Names:
  • BAY 80-6946
  • PI3K Inhibitor BAY 80-6946

Drug: Copanlisib Hydrochloride
Given IV
Other Names:
  • 5-Pyrimidinecarboxamide, 2-Amino-N-(2,3-dihydro-7-methoxy-8-(3-(4-morpholinyl)propoxy)imidazo(1,2-C)quinazolin-5-yl)-, Hydrochloride (1:2)
  • Aliqopa
  • BAY 80-6946 Dihydrochloride
  • BAY-80-6946 Dihydrochloride
  • Copanlisib Dihydrochloride

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol Z1I (BRCA1 or BRCA2 gene mutation)
Patients with BRCA1 or BRCA2 gene mutation receive adavosertib PO QD for 5 days for 2 weeks. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
 Drug: Adavosertib
Given PO
Other Names:
  • AZD-1775
  • AZD1775
  • MK-1775
  • MK1775

Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol Z1K (AKT mutation)
Patients receive ipatasertib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Drug: Ipatasertib
Given PO
Other Names:
  • GDC-0068
  • RG-7440

Other: Laboratory Biomarker Analysis
Undergo molecular analysis
Experimental: Subprotocol Z1L (BRAF fusion, aberration or non-V600 mutation)
Patients with a BRAF non-V600 mutation or BRAF fusion, or another BRAF aberration receive ulixertinib (BVD-523FB) PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Drug: Ulixertinib
Give PO
Other Names:
  • BVD-523
  • VRT752271
Experimental: Subprotocol Z1M (LAG-3 expression >= 1%)
Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1.Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
 Other: Cytology Specimen Collection Procedure
Optional correlative studies
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo molecular analysis

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • CMAB819
  • MDX-1106
  • NIVO
  • Nivolumab Biosimilar CMAB819
  • ONO-4538
  • Opdivo

Biological: Relatlimab
Given IV
Other Names:
  • BMS-986016
  • BMS986016
  • Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Up to 3 years ]
    Defined as the percentage of patients whose tumors have a complete or partial response to treatment. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria for solid tumors, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided confidence intervals will be calculated.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From registration onto that step until death, or censored at the date of last contact, assessed up to 3 years ]
    Will be evaluated specifically for each drug (or step). Overall survival will be estimated using the Kaplan-Meier method.

  2. Progression free survival [ Time Frame: From entry onto that step until determination of disease progression or death from any cause, censored at the date of last disease assessment for patients who have not progressed, assessed at 6 months ]
    Progression free survival will be estimated using the Kaplan-Meier method. For each treatment arm, 90% two-sided confidence intervals will be calculated.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0)

  • Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration; patients that are pregnant or breast feeding are excluded; a patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:

    • Has achieved menarche at some point
    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse prior to study entry, for the duration of study participation, and for 4 months after completion of study; should a patient or partner of the patient become pregnant or suspect a pregnancy while participating in this study, the treating physician should be informed immediately

  • Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:

    • Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met; if the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard OR
    • Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
    • NOTE: No other prior malignancy is allowed except for the following:
    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission
    • Any other cancer from which the patient has been disease-free for 5 years
  • Patients must have measurable disease

  • Patients must meet the criteria below

    • Tumor tissue for the confirmation of "rare variant" by the MATCH assay is to be submitted, preferably from the same time of collection as that used to determine patient candidacy for treatment arm assignment

      • Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy. There is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met
      • Patients may have received other non-targeted, immunotherapy or targeted treatment between the prior genetic testing at the outside lab and registration to Step 0. The decision to stop such treatment in favor of participation in MATCH, if no further clinical benefit is expected, is per the treating physician's discretion. Documentation of a lack of response to the prior treatment is not required in these cases
      • Patients with an applicable "rare variant" must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following notification of treatment assignment

      • Patient meets one of the following criteria:

        • Patient is a candidate for Z1M based on local CLIA assessment of MMRd by immunohistochemistry (IHC) or MSI status by polymerase chain reaction (PCR), adequate tumor tissue is available for submission for mandatory central screening IHC and the patient will be able to meet the eligibility criteria for Z1M within 4 weeks following notification of treatment assignment OR
        • The sites have received results from one of the designated outside laboratories indicating a "rare variant" that is an actionable Mutation of Interest (aMOI) for specific select subprotocols
    • NOTE: There is no particular window of time after receiving the sequencing report notification of potential eligibility from an outside lab in which the patient must be registered to Step 0, but treatment slots will be assigned on a first come, first serve basis to those who do register to Step 0, and are not held for those notified of potential eligibility who do not register to Step 0
    • NOTE: Treatment assignment (and the start of the associated deadline for Step 1 registration) may occur shortly after Step 0 registration. Note that certain "rare variant" arms require submission of archival tissue for central IHC testing to determine treatment assignment. For those arms, adequate tissue for the central IHC is required to be available for submission
    • NOTE: Other potential aMOIs that would be eligibility criteria for "NON RARE" arms, as determined by the designated laboratories, are not applicable for this process in MATCH
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months
  • Patients must be able to swallow tablets or capsules; a patient with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible

  • Patients who are human immunodeficiency virus (HIV)-positive are eligible if:

    • CD4+ cell count greater or equal to 250 cells/mm^3
    • If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used
    • No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
    • Probable long-term survival with HIV if cancer were not present

  • Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease

    • NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist
    • NOTE: For patients entering the study via the original screening process, patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the only intervening treatment permitted is prior therapy that the patient already received prior to Step 0 registration; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment
    • NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol
  • Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment

  • Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted; patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment (Step 1, 3, 5, 7)

    • NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):

      • Temporary steroid use: e.g. for computed tomography (CT) imaging in setting of contrast allergy
      • Low dose steroid use for appetite
      • Chronic inhaled steroid use
      • Steroid injections for joint disease
      • Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease
      • Topical steroid
      • Steroids required to manage toxicity related to study treatment, as described in the subprotocols

      • Steroids required as pre- or post-chemotherapy medication for acceptable intervening chemotherapy

        • NOTE: Steroids must be completed alongside last dose of chemotherapy
  • Leukocytes >= 3,000/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
  • Absolute neutrophil count (ANC) >= 1,500/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
  • Platelets >= 100,000/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
  • NOTE: Patients with documented bone marrow involvement by lymphoma are not required to meet the above hematologic parameters, but must have a platelet count of at least 75,000/mcL and neutrophil count of at least 1,000/mcL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x institutional ULN is permitted) (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (up to 5 times ULN in presence of liver metastases) (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)

  • Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional ULN

    • As defined by the Cockcroft-Gault equation (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)

  • Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria:

    • Resting corrected QT interval (QTc) =< 480 msec

      • NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs

    • The following only need to be assessed if the mean QTc > 480 msec

      • Check potassium and magnesium serum levels
      • Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc
      • For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required
      • For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc
      • Patient must not have hypokalemia (value < institutional lower limit of normal)

    • No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval

      • NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs
  • ELIGIBILITY CRITERIA FOR FIRST TREATMENT (STEP 1)
  • NOTE: For patients entering step 0 with assay results from outside laboratories, no systemic treatment is allowed after step 0 registration

  • As MATCH is designed to add additional subprotocols, implement limited expansions of accrual for certain subprotocols, and/or amend existing arm-specific eligibility criteria, some patients entering under the original screening method may be eligible to have their results rerun in MATCHbox, even if they did not match to a treatment initially or did not receive a treatment assignment due to a lack of available assignment slots; patients whose sequence results will be rerun through MATCHbox must also meet the following criteria:

    • Samples must have been collected within 5 months of the activation of the addendum, as there is an additional month needed to get the patients on trial
    • Patient has not had treatment within the 5 months that resulted in a PR or better after the performance of the screening assessment
    • Patient must meet eligibility criteria, including performance status 1 or better and life expectancy of at least 3 months

    • Patients must meet the eligibility requirements with the following exceptions:

      • Patients may have received other non-targeted, immunotherapy or targeted treatment, which could be stopped in favor of returning to MATCH, if no response to the interim treatment has occurred and no further benefit is expected from this interim treatment, per the treating physician's discretion; documentation of a lack of response to the interim treatment is not required in these cases; however, the following restrictions apply:

        • Enrollment onto another investigational therapeutic study is not permitted
        • Patient cannot be responding to interim treatment, since the benefit of the MATCH treatment is unknown and may deprive patient of an effective treatment if it were given when a patient is responding to another treatment
    • NOTE: Patients meeting these criteria will NOT be biopsied at this time point; instead, their step 0 results will be re-interrogated to determine if another treatment is available
  • ELIGIBILITY CRITERIA FOR SECOND SCREENING (STEP 2)

  • Patient's disease has progressed on Step 1 treatment or patient could not tolerate assigned treatment

    • NOTE: PATIENTS ENTERING STEP 1 WITH A "RARE VARIANT" FROM AN "OUTSIDE" LAB ARE NOT ELIGIBLE FOR STEP 2

  • No response and progression (or inability to tolerate further treatment) occurred < 6 months from start of step 1 treatment

    • NOTE: Patients meeting these criteria will NOT be biopsied at this time point; instead, their step 0 MATCH assay results will be re-interrogated to determine if another treatment is available upon registration to this study step; it is not necessary to confirm the availability of another potential treatment assignment in advance; only aMOIs detected by the MATCH assay may be used for the determination of eligibility to a relevant subprotocol OR
  • Progression (or inability to tolerate further treatment) occurred after a (1) response OR (2) after >= 6 months from start of step 1 treatment; patient must have tumor amenable to percutaneous biopsy and be willing and able to undergo a tumor biopsy or bone marrow aspirate for collection and submission of tumor tissue OR patient will be undergoing a procedure due to medical necessity during which the tissue may be collected for the central determination of the presence of one or more of the specific "actionable" mutations/amplifications of interest (aMOI); archived specimens cannot be accepted
  • Patients must meet eligibility criteria as defined in step 0
  • ELIGIBILITY CRITERIA FOR SECOND TREATMENT (STEP 3)
  • NOTE: If screening biopsy samples were submitted during step 2, patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results however, lack of response must be documented prior to registration to step 3; new non-protocol treatment will NOT be permitted as intervening therapy after registration to step 2; the decision to stop the intervening nonprotocol treatment will be left up to the treating physician if patient has an aMOI; waiting periods as described will apply
  • ELIGIBILITY CRITERIA FOR THIRD SCREENING (STEP 4)

  • Patient's disease has progressed on step 3 treatment or patient could not tolerate assigned treatment

    • Patient must meet one of the following criteria:

      • No response and progression (or inability to tolerate further treatment) occurred < 6 months from start of step 3 (second) treatment AND a biopsy was performed at step 2 screening

        • NOTE: Patients meeting these criteria will NOT be biopsied at this time point; instead, their latest MATCH assay results will be re-interrogated to determine if another treatment is available upon registration to this study step; it is not necessary to confirm the availability of another potential treatment assignment in advance OR
      • Progression (or inability to tolerate further treatment) occurred on step 3 treatment and a biopsy was not performed at step 2 screening (due to presence of additional aMOIs at that stage); patient must have tumor amenable to percutaneous biopsy and be willing and able to undergo a tumor biopsy or bone marrow aspiration for collection and submission of tumor tissue OR patient will be undergoing a procedure due to medical necessity during which the tissue may be collected for the central determination of the presence of one or more of the specific "actionable" mutations/amplifications of interest; biopsy must not be considered to be more than minimal risk to the patient; archived specimens cannot be accepted

  • Patients must meet eligibility criteria as defined in step 0

    • NOTE: A patient may have a maximum of 2 screening biopsies (not including re-biopsy due to assay failure), and 2 MATCH treatments per biopsy (if > 1 aMOI)
  • ELIGIBILITY CRITERIA FOR THIRD TREATMENT (STEP 5)
  • NOTE: If screening biopsy was submitted on step 4, patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results however, lack of response must be documented prior to registration to step 5; new non-protocol treatment will NOT be permitted as intervening therapy after registration to step 4; the therapy cannot be an arm in the MATCH trial; the decision to stop the intervening nonprotocol treatment will be left up to the treating physician if patient has an aMOI; waiting periods as described will apply
  • ELIGIBILITY CRITERIA FOR FOURTH SCREENING (STEP 6)
  • Patient's disease has progressed on step 5 protocol treatment or patient could not tolerate assigned treatment

  • Patient must have had no response, and progression (or inability to tolerate further treatment) occurred < 6 months from start of step 5 treatment AND a biopsy was performed at step 4 screening

    • NOTE: Patients meeting these criteria will NOT be biopsied at this time point; instead, based on their 2nd biopsy, their results will be interrogated to determine if another treatment is available upon registration to this study step; it is not necessary to confirm the av
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465060


Locations
Show Show 1433 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Keith T Flaherty ECOG-ACRIN Cancer Research Group
  Study Documents (Full-Text)

Documents provided by National Cancer Institute (NCI):
Study Protocol and Statistical Analysis Plan  [PDF] October 9, 2020

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02465060    
Other Study ID Numbers: NCI-2015-00054
NCI-2015-00054 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAY131 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
EAY131 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U24CA196172 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: February 2023
Additional relevant MeSH terms:
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Lymphoma
Carcinoma
Neoplasms
Melanoma
Multiple Myeloma
Neoplasms, Plasma Cell
Glioma
Breast Neoplasms
Lung Neoplasms
Colorectal Neoplasms
Endometrial Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Prostatic Neoplasms
Pancreatic Neoplasms
 Esophageal Neoplasms
Stomach Neoplasms
Urinary Bladder Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Thyroid Neoplasms
Uterine Neoplasms
Carcinoma, Hepatocellular
Skin Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Thyroid Diseases
Recurrence
Neoplasms by Histologic Type
Lymphoproliferative Disorders