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Kinase Inhibitor

Targeted Therapy for Cancer

Phase 2

Waitlist Available

Led By Keith T Flaherty

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any prior therapy, radiotherapy, 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

Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment

Must not have

Patients with specific cardiac criteria outside the defined range are excluded

Patients with a history of specific malignancies are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses genomic testing to direct cancer treatment. Patients with cancer that has progressed after standard treatment or for which there is no agreed-upon treatment may benefit.

Who is the study for?

This trial is for patients with advanced solid tumors, lymphomas, or multiple myeloma that have worsened after standard treatment or lack a consensus treatment. Participants must be finished with previous treatments and recovered from their effects, not expect to conceive children, have an ECOG status of <=1 indicating they are relatively active, and meet specific health criteria including heart function and blood tests.

What is being tested?

The MATCH trial is testing whether targeting therapy based on genetic abnormalities in the tumor cells can benefit patients whose cancer has progressed. It involves genetic testing to identify mutations or changes in the tumor's DNA and then matching patients with therapies specifically designed to target those genetic features.

What are the potential side effects?

Potential side effects depend on the targeted therapy given but may include skin reactions, digestive issues, fatigue, liver problems, heart complications like QTc prolongation (a type of irregular heartbeat), allergic reactions to medication components, increased risk of infection due to immune system impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It's been over 4 weeks since my last cancer treatment or major surgery, and any side effects are mild.

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I finished treatment for brain cancer or metastases more than 4 weeks ago.

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I have a confirmed diagnosis of cancer that needs treatment and has shown progression.

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I can do light work and my doctor expects me to live at least 3 more months.

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I stopped taking steroids at least a week ago and haven't taken any since.

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I have had treatment for skin cancer that is not melanoma.

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I have not had a hysterectomy or both ovaries removed and have had a menstrual cycle in the last 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart function is within the normal range.

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I have not had certain types of cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

6-month progression free survival (PFS) rate

Overall survival (OS)

Progression free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

38Treatment groups

Experimental Treatment

Group I: Subprotocol Z1M (LAG-3 expression >= 1%)Experimental Treatment4 Interventions

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.

Group II: Subprotocol Z1L (BRAF fusion, aberration or non-V600 mutation)Experimental Treatment3 Interventions

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.

Group III: Subprotocol Z1K (AKT mutation)Experimental Treatment3 Interventions

Patients receive ipatasertib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Subprotocol Z1I (BRCA1 or BRCA2 gene mutation)Experimental Treatment3 Interventions

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.

Group V: Subprotocol Z1H (PTEN mutation)Experimental Treatment4 Interventions

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.

Group VI: Subprotocol Z1G (PTEN loss)Experimental Treatment4 Interventions

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.

Group VII: Subprotocol Z1F (PIK3CA mutation)Experimental Treatment7 Interventions

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.

Group VIII: Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion)Experimental Treatment8 Interventions

Patients with NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib (LOXO-101) PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.

Group IX: Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC)Experimental Treatment3 Interventions

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.

Group X: Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein)Experimental Treatment3 Interventions

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.

Group XI: Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC)Experimental Treatment3 Interventions

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.

Group XII: Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61)Experimental Treatment3 Interventions

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.

Group XIII: Subprotocol Y (Akt mutation)Experimental Treatment3 Interventions

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.

Group XIV: Subprotocol X (DDR2 S768R, I638F, or L239R mutation)Experimental Treatment3 Interventions

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.

Group XV: Subprotocol W (FGFR pathway aberrations)Experimental Treatment3 Interventions

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.

Group XVI: Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation)Experimental Treatment9 Interventions

Patients with cKIT exon 9, 11, 13, or 14 mutation receive sunitinib PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.

Group XVII: Subprotocol U (NF2 inactivating mutation)Experimental Treatment4 Interventions

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.

Group XVIII: Subprotocol T (SMO or PTCH1 mutation)Experimental Treatment9 Interventions

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. Patients undergo ECHO or nuclear study during screening, tumor biopsy on study and CT scan, MRI and blood sample collection throughout the study.

Group XIX: Subprotocol S2 (GNAQ or GNA11 mutation)Experimental Treatment3 Interventions

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.

Group XX: Subprotocol S1 (NF1 mutation)Experimental Treatment3 Interventions

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.

Group XXI: Subprotocol R (BRAF fusion or BRAF non-V600 mutation)Experimental Treatment3 Interventions

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.

Group XXII: Subprotocol Q (HER2 amplification)Experimental Treatment4 Interventions

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.

Group XXIII: Subprotocol P (PTEN loss)Experimental Treatment3 Interventions

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.

Group XXIV: Subprotocol N (PTEN mutation or deletion and PTEN expression)Experimental Treatment3 Interventions

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.

Group XXV: Subprotocol M (TSC1 or TSC2 mutation)Experimental Treatment3 Interventions

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.

Group XXVI: Subprotocol L (mTOR mutation)Experimental Treatment3 Interventions

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.

Group XXVII: Subprotocol K2 (FGFR mutation or fusion)Experimental Treatment7 Interventions

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. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study.

Group XXVIII: Subprotocol K1 (FGFR amplification)Experimental Treatment7 Interventions

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. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.

Group XXIX: Subprotocol J (HER2 amplification >= 7 copy numbers)Experimental Treatment9 Interventions

Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.

Group XXX: Subprotocol I (PIK3CA mutation)Experimental Treatment3 Interventions

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.

Group XXXI: Subprotocol H (BRAF V600E/R/K/D mutation)Experimental Treatment5 Interventions

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.

Group XXXII: Subprotocol G (ROS1 translocation or inversion)Experimental Treatment3 Interventions

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.

Group XXXIII: Subprotocol F (ALK translocation)Experimental Treatment3 Interventions

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.

Group XXXIV: Subprotocol E (EGFR T790M or rare activating mutation)Experimental Treatment8 Interventions

Patients with EGFR T790M or rare activating mutation receive osimertinib (AZD9291) PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or multigated acquisition scan (MUGA) during screening, and biopsy and collection of blood samples on trial and at end of treatment.

Group XXXV: Subprotocol C2 (MET exon 14 deletion/mutation)Experimental Treatment6 Interventions

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. Patients undergo tumor biopsy on study and undergo radiologic evaluation and blood sample collection throughout the study.

Group XXXVI: Subprotocol C1 (MET amplification)Experimental Treatment6 Interventions

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. Patients also undergo radiologic evaluation and collection of blood samples throughout the study. Patients may undergo biopsy at screening, on study, and/or at end of treatment.

Group XXXVII: Subprotocol B (HER2 activating mutation)Experimental Treatment4 Interventions

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.

Group XXXVIII: Subprotocol A (EGFR activating mutation)Experimental Treatment10 Interventions

Patients with EGFR activating mutation receive afatinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Capivasertib

2021

Completed Phase 1

~130