Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Running, not enrolling · Phase 2
Conditions studied: Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma, Cervical Carcinoma, Colon Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma, Esophageal Carcinoma, Exocrine Pancreas Carcinoma, Gastric Carcinoma, Glioma, Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Kidney Carcinoma, Liver Carcinoma, Lung Carcinoma, Lymphoma, Malignant Uterine Corpus Neoplasm, Malignant Uterine Neoplasm, Melanoma, Multiple Myeloma, Ovarian Carcinoma, 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 Malignant Uterine Corpus Neoplasm, Recurrent Melanoma, Recurrent Multiple Myeloma, Recurrent Ovarian Carcinoma, Recurrent Pancreatic Carcinoma, Recurrent Prostate Carcinoma, Recurrent Rectal Carcinoma, Recurrent Skin Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma, Skin Carcinoma, Thyroid Gland Carcinoma
In brief
This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must 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.
Key facts
- Study ID
- NCT02465060
- Run by
- National Cancer Institute (NCI)
- People needed
- 6452
- Starts
- 2015-08-17
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0)
- Patients must be >= 18 years of age. Because no dosing or adverse event data are currently available on the use of study investigational agents in patients < 18 years of age, children are excluded from this study
- 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 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 Clinical Laboratory Improvement Act (CLIA) assessment of mismatch repair deficiency (MMRd) by immunohistochemistry (IHC) or microsatellite instability (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
Where it is running
- Thomas Hospital — Fairhope, Alabama, United States
- Mobile Infirmary Medical Center — Mobile, Alabama, United States
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
- Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States
- Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
- Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
- Alaska Regional Hospital — Anchorage, Alaska, United States
- Alaska Women's Cancer Care — Anchorage, Alaska, United States
- Anchorage Oncology Centre — Anchorage, Alaska, United States
- Katmai Oncology Group — Anchorage, Alaska, United States
- Providence Alaska Medical Center — Anchorage, Alaska, United States
- Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
- CTCA at Western Regional Medical Center — Goodyear, Arizona, United States
- Kingman Regional Medical Center — Kingman, Arizona, United States
- Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
- Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
- Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Kaiser Permanente-Anaheim — Anaheim, California, United States
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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