| Do you have any of these conditions: Recurrent Ovarian Carcinoma or Ductal Carcinoma In Situ or Recurrent Cervical Cancer or Recurrent Bladder Cancer or Urothelial Cancer or Lymphoma or R...? |
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| Do you have any of these conditions: cancer ovarian or Bladder Carcinoma or Recurrent Rectal Carcinoma or Endometrial Carcinoma or Ductal Carcinoma In Situ or Recurrent Esophageal Carcino...? |
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| Do you have any of these conditions: Recurrent Thyroid Cancer or Lymphoproliferative Disorder or Recurrent Skin Carcinoma or Recurrent Glioma or Colorectal Cancer or Recurrent Uterine Cor...? |
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| Do you have any of these conditions: Cervical Cancer or Gliomas or Recurrent Prostate Cancer or Malignant neoplasm of prostate or Recurrent Uterine Corpus Carcinoma or Non-melanoma Skin C...? |
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| Do you have any of these conditions: Nonmelanoma Skin Cancer or Endometrial Cancer or Gliomas or Biliary Tract Cancer or Colon cancer; rectal cancer or Recurrent Rectal Cancer or breast c...? |
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| Do you have any of these conditions: Advanced Malignant Solid Neoplasm or Adenocarcinoma of Rectum or carcinoma of the bladder or Malignant neoplasm of prostate or Gastric Carcinoma or Ly...? |
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| Do you have any of these conditions: Colorectal Cancer or Recurrent Bladder Carcinoma or cancer of the cervix or Recurrent Liver Carcinoma or Urothelial Cancer or Lymphoproliferative diso...? |
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| Do you have any of these conditions: Refractory Malignant Solid Neoplasm or Malignant Melanoma or Kidney Cancer or Prostate Cancer, Early, Recurrent or carcinoma of the skin or Renal Canc...? |
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| Do you have any of these conditions: Renal Cancer or carcinoma of the bladder or lymphomas or cancer of the esophagus or Carcinoma of the Head and Neck or Recurrent Head and Neck Carcinom...? |
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| Do you have any of these conditions: melanoma or Malignant neoplasm of kidney or Recurrent Prostate Cancer or Recurrent Thyroid Gland Carcinoma or ovarian carcinomas or Biliary Tract Canc...? |
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| Do you have any of these conditions: Epithelial Ovarian Carcinoma or Liver and Intrahepatic Bile Duct Carcinoma or Recurrent Gastric Carcinoma or Recurrent Prostate Cancer or Recurrent Lu...? |
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| Do you have any of these conditions: Uterine Cancer or Recurrent Melanoma or Recurrent Uterine Corpus Cancer or Urothelial Cancer or Refractory Lymphoma or Pancreatic Cancer or Colon canc...? |
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| Do you have any of these conditions: carcinoma of the bladder or Ductal Carcinoma In Situ or Multiple Myeloma or carcinoma of the skin or Endometrial Cancer or glial tumor or cervix cance...? |
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| Do you have any of these conditions: Lymphoma or Recurrent Glioma or Malignant neoplasm of colon or carcinoma of the cervix or Cervical Cancer or Uterine Cancer or rectal carcinoma or car...? |
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| Is your age greater than or equal to 18 yrs? |
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| Do you have any of these conditions: Recurrent Colon Carcinoma or Bladder Carcinoma or Recurrent Cervical Carcinoma or Recurrent Skin Carcinoma or Gliomas or Recurrent Prostate Cancer or ...? |
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| Do you have any of these conditions: Urothelial Cancer or Lung Cancer or Rectal Cancer or Advanced Malignant Solid Tumor or Recurrent Uterine Corpus Cancer or ovarian carcinomas or Cervic...? |
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| Do you have any of these conditions: Recurrent Thyroid Cancer or Lymphoproliferative disorders or Recurrent Uterine Corpus Carcinoma or Cervical Cancer or Thyroid Cancer or colon carcinom...? |
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| Do you have any of these conditions: Recurrent Pancreatic Carcinoma or cancer of the esophagus or ovarian carcinoma or Thyroid Adenoma or Recurrent Esophageal Carcinoma or Lung Neoplasm o...? |
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| Do you have any of these conditions: Recurrent Melanoma or carcinoma lung or rectal carcinoma or Non-Hodgkin's Lymphoma or Malignant neoplasm of colon or Liver and Intrahepatic Bile Duct ...? |
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| Do you have any of these conditions: Refractory Plasma Cell Myeloma or prostate carcinoma or Glioma or bladder cancer or Recurrent Rectal Cancer or cancer of the esophagus or Lung Neoplas...? |
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| Do you have any of these conditions: Recurrent Thyroid Cancer or Recurrent Breast Cancer or Prostate Cancer or Bladder Carcinoma or Esophageal Carcinoma or Recurrent Uterine Corpus Cancer...? |
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| Do you have any of these conditions: cancer of the pancreas or Recurrent Malignant Solid Neoplasm or Kidney Cancer or Carcinoma of the Head and Neck or ovarian epithelial carcinoma or rec...? |
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| Do you have any of these conditions: Recurrent Breast Cancer or Recurrent Bladder Cancer or Refractory Malignant Solid Neoplasm or Recurrent Pancreatic Cancer or carcinoma of the cervix u...? |
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| Do you have any of these conditions: Recurrent Pancreatic Cancer or Recurrent Bladder Carcinoma or Advanced Solid Tumor or Malignant neoplasm of kidney or Prostate Cancer or Renal Cell Ca...? |
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| Do you have any of these conditions: Bladder Carcinoma or Glioma or Malignant neoplasm of kidney or Prostate Cancer or Pancreatic Cancer or Advanced Malignant Solid Neoplasm or Recurrent ...? |
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| Gender: Male or Female |
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| ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0) |
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| Women 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 female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following |
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| criteria |
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| Has not undergone a hysterectomy or bilateral oophorectomy; or |
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| 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) |
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| Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of study; should a woman become pregnant or suspect while she or her partner is participating in this study, she should inform her treating physician immediately |
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| 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 |
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| 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 |
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| Patients for whose disease no standard treatment exists that has been shown to prolong overall survival |
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| NOTE: No other prior malignancy is allowed except for the following |
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| Adequately treated basal cell or squamous cell skin cancer |
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| In situ cervical cancer |
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| Adequately treated stage I or II cancer from which the patient is currently in complete remission |
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| Any other cancer from which the patient has been disease-free for 5 years |
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| Patients must have measurable disease |
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| 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 |
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| The following requirements apply |
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| 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 |
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| NOTE: The content and format of these specific notifications for the Outside Assay process will vary depending on the designated outside lab in question, as they are each responsible for their own outreach efforts; it is strongly recommended that the designated outside laboratory be contacted to confirm the format and receipt of this notification prior to registering any patients to Step 0 |
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| 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 |
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| NOTE: The receipt of this notification (and the start of the associated deadline for Step 1 registration) may occur shortly after Step 0 registration, since these patients will not be submitting tissue for screening purposes; however, for certain "rare variant" arms, submission of archival tissue for central immunohistochemistry (IHC) testing may be required |
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| 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 |
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| There is no particular window of time after 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 |
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| 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 |
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| NOTE: Other potential aMOIs that would be eligibility criteria for "NON RARE" arms, as determined by the designated laboratories, are not applicable for this process in MATCH |
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| NOTE: 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 evaluated by the designated outside laboratory |
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| Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months |
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| Patients must be able to swallow tablets or capsules; a patient with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible |
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| Patients who are human immunodeficiency virus (HIV)-positive are eligible if |
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| CD4+ cell count greater or equal to 250 cells/mm^3 |
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| If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used |
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| No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts |
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| Probable long-term survival with HIV if cancer were not present |
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| Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [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 |
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| NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist |
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| NOTE: For patients entering the study via the original screening process, patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the only intervening treatment permitted is prior therapy that the patient already received prior to Step 0 registration; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment |
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| NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol |
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| Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment |
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| Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted; 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 1, 3, 5, 7) |
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| NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid) |
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| Temporary steroid use: e.g. for computed tomography (CT) imaging in setting of contrast allergy |
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| Low dose steroid use for appetite |
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| Chronic inhaled steroid use |
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| Steroid injections for joint disease |
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| Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease |
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| Topical steroid |
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| Steroids required to manage toxicity related to study treatment, as described in the subprotocols |
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| Steroids required as pre- or post-chemotherapy medication for acceptable intervening chemotherapy |
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| NOTE: Steroids must be completed alongside last dose of chemotherapy |
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| Leukocytes >= 3,000/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration) |
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| Absolute neutrophil count >= 1,500/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration) |
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| Platelets >= 100,000/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration) |
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| NOTE: Patients with documented bone marrow involvement by lymphoma are not required to meet the above hematologic parameters, but must have a platelet count of at least 75,000/mcL and neutrophil count of at least 1,000/mcL |
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| Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x institutional ULN is permitted) (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration) |
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| Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (up to 5 times ULN in presence of liver metastases) (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration) |
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| Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal |
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| As defined by the Cockcroft-Gault equation (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration) |
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| Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria |
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| Resting corrected QT interval (QTc) =< 480 msec |
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| NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs |
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| The following only need to be assessed if the mean QTc > 480 msec |
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| Check potassium and magnesium serum levels |
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| Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc |
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| For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required |
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| For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc |
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| Patient must not have hypokalemia (value < institutional lower limit of normal) |
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| No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval |
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| NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs |
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| ELIGIBILITY CRITERIA FOR FIRST TREATMENT (STEP 1) |
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| If patients have been biopsied or submitted archived tumor tissue obtained within the last 6 months for assessment with the MATCH assays, patients may receive non-protocol treatment after biopsy/tissue submission (if clinically indicated) until they receive notification of results however, lack of response must be documented prior to registration to step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; for patients entering step 0 with assay results from outside laboratories, no systemic treatment is allowed after step 0 registration; the decision to stop the intervening nonprotocol treatment will be left up to the treating physician if patient has an aMOI; waiting periods as described will apply |
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| As MATCH is designed to add additional subprotocols, implement limited expansions of accrual for certain subprotocols, and/or amend existing arm-specific eligibility criteria, some patients entering under the original screening method may be eligible to have their results rerun in MATCHbox, even if they did not match to a treatment initially or did not receive a treatment assignment due to a lack of available assignment slots; patients whose sequence results will be rerun through MATCHbox must also meet the following criteria |
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| Samples must have been collected within 5 months of the activation of the addendum, as there is an additional month needed to get the patients on trial |
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| Patient has not had treatment within the 5 months that resulted in a PR or better after the performance of the screening assessment |
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| Patient must meet eligibility criteria, including performance status 1 or better and life expectancy of at least 3 months |
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| Patients must meet the eligibility requirements with the following exceptions |
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| Patients may have received other non-targeted, immunotherapy or targeted treatment, which could be stopped in favor of returning to MATCH, if no response to the interim treatment has occurred and no further benefit is expected from this interim treatment, per the treating physician's discretion; documentation o |
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