A Phase 2 interventional study of Biopsy Procedure and Biospecimen Collection in Advanced Lymphoma, Advanced Malignant Solid Neoplasm and Refractory Lymphoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 44 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Inclusion Criteria:
Patients receive crizotinib PO 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.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Drug: Crizotinib · Procedure: Radiologic Examination
Undergo biopsy
Also known as: Biopsy, BIOPSY_TYPE, Bx
Undergo collection of blood samples
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given PO
Also known as: Alkixen, Crizocent, MET Tyrosine Kinase Inhibitor PF-02341066, PF 02341066, PF-02341066, PF-2341066, PF02341066, Xalkori
Undergo radiologic evaluation
Also known as: Radiologic Evaluation, Radiologic Exam
Objective Response Rate (ORR)
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.
Time frame: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
6-month Progression Free Survival (PFS)
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
Time frame: Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined
Progression Free Survival
PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.
Time frame: Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Subprotocol C1 was activated on May 31, 2016. Forty-four patients were enrolled on EAY131-C1 between July 29, 2016, and November 12, 2021. Thirteen patients were enrolled on the basis of the results from the NCI-MATCH assay and 31 on the basis of the outside assay results.
| Milestone | Treatment (Crizotinib) |
|---|---|
| Started | 44 |
| Started protocol therapy | 40 |
| Eligible, treated and mutation status confirmed | 28 |
| Completed | 0 |
| Not completed | 44 |
| Withdrew: Ineligible or never started | 4 |
| Withdrew: Mutation status not confirmed | 12 |
| Withdrew: Adverse event | 4 |
| Withdrew: Disease progression | 19 |
| Withdrew: Other complicating disease | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: On treatment | 1 |
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.
| percentage of participants | Treatment (Crizotinib) |
|---|---|
| Objective Response Rate (ORR) | 14 (5 to 29.8) |
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
| percentage of participants | Treatment (Crizotinib) |
|---|---|
| 6-month Progression Free Survival (PFS) | 14.3 (5.6 to 26.8) |
PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.
| months | Treatment (Crizotinib) |
|---|---|
| Progression Free Survival | 3.4 (1.8 to 3.7) |
Collected over Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Crizotinib) | 36/44 (81.8%) | 14/40 (35%) | 33/40 (82.5%) |
| Event | Treatment (Crizotinib) |
|---|---|
| FatigueGeneral disorders and administration site conditions | 4/40 |
| AnemiaBlood and lymphatic system disorders | 3/40 |
| Lung infectionInfections and infestations | 2/40 |
| Alanine aminotransferase increasedInvestigations | 2/40 |
| HypotensionVascular disorders | 2/40 |
| Sinus bradycardiaCardiac disorders | 1/40 |
| DiarrheaGastrointestinal disorders | 1/40 |
| NauseaGastrointestinal disorders | 1/40 |
| VomitingGastrointestinal disorders | 1/40 |
| Bone infectionInfections and infestations | 1/40 |
| Event | Treatment (Crizotinib) |
|---|---|
| DiarrheaGastrointestinal disorders | 12/40 |
| NauseaGastrointestinal disorders | 12/40 |
| AnemiaBlood and lymphatic system disorders | 10/40 |
| ConstipationGastrointestinal disorders | 9/40 |
| Alkaline phosphatase increasedInvestigations | 9/40 |
| Lymphocyte count decreasedInvestigations | 9/40 |
| Edema limbsGeneral disorders and administration site conditions | 8/40 |
| FatigueGeneral disorders and administration site conditions | 8/40 |
| VomitingGastrointestinal disorders | 7/40 |
| Aspartate aminotransferase increasedInvestigations | 7/40 |
Patients who were eligible, started protocol therapy, and had mutation status confirmed at the analysis time were the analyzable patients
| Age, Continuous(years) | Treatment (Crizotinib) |
|---|---|
| Median | 67 (28 to 82) |
| Sex: Female, Male(Participants) | Treatment (Crizotinib) |
|---|---|
| Female | 9 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Crizotinib) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 26 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Treatment (Crizotinib) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
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Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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