Last updated on July 2019

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors Lymphomas or Multiple Myeloma (The MATCH Screening Trial)


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

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 37 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.

Clinical Study Identifier: NCT02465060

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Honolulu, HI United States
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Kuakini Medical Center

Honolulu, HI United States
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Saint Joseph Medical Center

Bloomington, IL United States
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Swedish Covenant Hospital

Chicago, IL United States
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Saint Francis Hospital

Evanston, IL United States
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Trinity Medical Center

Moline, IL United States
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Springfield Clinic

Springfield, IL United States
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Memorial Medical Center

Springfield, IL United States
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Woodland Cancer Care Center

Michigan City, IN United States
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Memorial Hospital of South Bend

South Bend, IN United States
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Mercy Hospital

Cedar Rapids, IA United States
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Iowa Methodist Medical Center

Des Moines, IA United States
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Broadlawns Medical Center

Des Moines, IA United States
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Iowa Lutheran Hospital

Des Moines, IA United States
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JCHC McCreery Cancer Center

Fairfield, IA United States
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McFarland Clinic PC-Jefferson

Jefferson, IA United States
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McFarland Clinic PC-Marshalltown

Marshalltown, IA United States
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Methodist West Hospital

West Des Moines, IA United States
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Newman Regional Health

Emporia, KS United States
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Saint Catherine Hospital

Garden City, KS United States
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Hays Medical Center

Hays, KS United States
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Via Christi Hospital-Pittsburg

Pittsburg, KS United States
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Oncology Hematology Care Inc-Crestview

Crestview Hills, KY United States
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Hardin Memorial Hospital

Elizabethtown, KY United States
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Saint Elizabeth Fort Thomas

Fort Thomas, KY United States
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Baptist Health Lexington

Lexington, KY United States
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Baptist Health Paducah

Paducah, KY United States
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Hematology/Oncology Clinic LLP

Baton Rouge, LA United States
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University Health-Conway

Monroe, LA United States
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MedStar Union Memorial Hospital

Baltimore, MD United States