NCT06357975

Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1)

MATCH Treatment Subprotocol C1: Crizotinib in Patients With Tumors With MET Amplification

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II MATCH treatment trial tests how well crizotinib works in treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have MET gene amplification. Crizotinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow.

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: Patients receive crizotinib orally (PO) twice daily (BID) 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 and collection of blood samples throughout the study. Patients may undergo biopsy at screening, on study, and/or at end of treatment. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 additional year. THE MATCH SCREENING TRIAL: Please see NCT02465060 for information on the MATCH Screening Protocol and applicable documents.

Conditions

• Advanced Lymphoma
• Advanced Malignant Solid Neoplasm
• Refractory Lymphoma
• Refractory Malignant Solid Neoplasm
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
DRUG	Crizotinib	Given PO
PROCEDURE	Radiologic Examination	Undergo radiologic evaluation

Timeline

• Start date: 2016-07-29
• Primary completion: 2022-11-15
• Completion: 2026-12-31
• First posted: 2024-04-10
• Last updated: 2026-03-19
• Results posted: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study