Research & Trial Information
Protocol#: ECOG – EAY131 (MATCH)
Cancer Type: Genomic Based Trial
- 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 must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy. Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/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.
- No other prior malignancy is allowed except for the following:a) adequately treated basal cell or squamous cell skin cancerb) in situ cervical cancer
c) adequately treated Stage I or II cancer from which the patient is currently in complete remission
d) 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 and 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. The following requirements apply:• The outside laboratory specifically notified the site that patient may be a potential candidate for MATCH due to a detected “rare variant. The outside lab reports are NOT sufficient for this purpose. Patents 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. Registration to Step 0 occurs 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 the eligibility criteria has been 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.
- Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin. Low molecular weight heparin is permitted for prophylactic or therapeutic use. Factor X inhibitors are permitted.
- Patients must have ECOG performance status ≤ 1 and a life expectancy of at least 3 months.
- Patients must not currently be receiving any other investigational agents.
- Any prior therapy, radiotherapy (except palliative radiation therapy of 30 Gy or less), 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 (except alopecia and lymphopenia) by start of treatment. Palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment. The radiotherapy must not be to a lesion that is included as measurable disease.
- Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy ≥ 4 weeks prior to start of treatment.
- Patients must have discontinued steroids ≥ 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted (see below). Patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment step (Step 1, 3, 5, 7).