[c09aa8]: / clusters / 9knumclustersv2 / clust_2613.txt

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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:\r\n* 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\r\n* Patients for whose disease no standard treatment exists that has been shown to prolong overall survival\r\n* 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 years
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 prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR \r\n* Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
No waiting period for patients who relapse while receiving standard maintenance therapy
Patient must meet at least one of the following criteria: a. Progressed or recurrent despite standard therapy, b. No standard therapy exists for this malignancy, c. Patient is intolerant of standard therapy, d. Patient is not a candidate for standard therapy, e. For AML and MDS patients: patient is not a candidate for allogeneic hematopoietic stem cell transplantation, f, For sarcoma patients: f-. Patient has disease that is metastatic or unresectable, f-. Patient with metastatic disease has had at least one prior line of therapy for metastatic disease, f-. No curative multimodality options exist
Phase I part: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version . (refer to Appendix ), who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
Subjects with histological- or cytological-confirmed, advanced cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists
Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or is appropriate.
Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST version ., who have progressed despite standard therapy or are intolerant to standard therapy, and for whom no effective therapy is available. Patients must fit into one of the following groups:
Disease that has progressed on standard therapy or for whom there is no other therapy option available
Patients without a curative therapy or whose tumor does not have standard chemotherapy
Patients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with measurable or non-measurable disease who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
Dose escalation phase only: Subject not responding to standard therapy or for whom no standard treatment exists
Dose expansion phase: Subject not responding to standard therapy or for whom no standard treatment exists with:
Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.
no longer be candidates for standard therapy or
have tumors for which there is no standard therapy
Have a histologically confirmed diagnosis of an advanced solid tumor or lymphoma that has progressed in spite of at least one prior line of treatment, and for which additional effective standard therapy is not available. For this study, effective standard therapy is defined as treatment that has been shown to be curative and/or to prolong survival. In addition, subjects who are considered to not be candidates for standard therapy or who decline standard therapy are eligible for this study; in such cases, documentation of the reason for omitting or declining a standard therapy is required.
Patients must have histologically confirmed metastatic or unresectable malignancy that is refractory to standard therapy or for which no standard therapy exists and where irinotecan is deemed a reasonable treatment option
Dose expansion groups of FAZ single agent and FAZ in combination with PDR: Patients with advanced/metastatic solid tumors with at least one measurable lesion as determined by RECIST version . who may or may not have received prior treatment with an immune checkpoint inhibitor (for FAZ single agent no treatment with an anti-PD-L inhibitor is permitted), who have progressed despite standard therapy, or for whom no standard therapy is available and fit into one of the following groups:
Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
All patients participating in this clinical trial must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
Patients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy
no effective conventional therapy exists
Phase I: histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist
Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
Relapsed following or progressed through standard therapy
Have a disease for which no standard effective therapy exists (i.e., a therapy that demonstrates a significant increase in survival)
Patients for whom no standard curative therapy exists
Part A of the study will include patients that have histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.
Subject has received at least one prior standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy.
All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
If an approved first-line standard therapy for the patients tumor is available, subjects must have failed, be intolerant to, be ineligible for, or have refused that treatment; enrollment of patients for whom no standard therapy exists or who decline standard therapy should be discussed with the principal investigator prior to enrollment; patients must have progressive disease on study entry
All patients must have received prior first line standard therapy or declined standard therapy
Patients for whom no standard curable therapy exists
Diagnosis of one of the following: . Part : Histologically- or cytological-confirmed diagnosis of non-resectable or metastatic solid malignancy. At the time of enrollment, subjects either: have progressed on prior therapy (radiographic documentation of progression is adequate for study participation) AND have no standard-of-care therapy that would be expected to achieve a durable clinical response, OR refuse standard therapy, OR are not candidates for standard therapy, OR have a disease for which no generally-accepted standard-of-care exists. . Part : Histologically- or cytologically-confirmed diagnosis of metastatic or non-resectable triple-negative breast cancer (TNBC) (estrogen receptor [ER]-/ progesterone receptor [PR]-/Human Epidermal Growth Factor Receptor [Her]-, as defined by local laboratory standards); metastatic or non-resectable transitional cell carcinoma of the bladder, ureter, or renal pelvis; recurrent GBM; or non-Hodgkin's lymphoma. At the time of enrollment, subjects either: have progressed on prior therapy (radiographic documentation of progression is adequate for study participation) AND have no standard-of-care therapy that would be expected achieve a durable clinical response, OR refuse standard therapy, OR are not candidates for standard therapy.
Patients must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
Have refused standard therapy
PHASE I COMPONENT: Histologic confirmation of relapsed/refractory solid tumors, including tumors of the central nervous system that have failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist; patients with diffuse pontine glioma are not required to have histologic confirmation of disease, and are eligible with radiologic confirmation
Failure to respond to or refractory to approved/standard therapy; or for whom standard therapy does not exist, or is not tolerable; or for whom approved/standard therapy is not considered to be sufficient or appropriate by the Investigator.
PROCUREMENT: Cancer is:\r\n* Recurrent or persistent after standard therapy OR\r\n* Patient is unable to receive standard therapy
TREATMENT: Cancer is:\r\n* Recurrent or persistent after standard therapy OR\r\n* Patient is unable to receive standard therapy
Patients with a recurrent/metastatic or refractory solid tumor that has progressed or did not respond to standard therapy, or for which no standard anticancer therapy exists or is too toxic
For initial VSTs and subsequent infusions: patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus, EBV, BK virus and/or HHV infection/disease persistent or recurrent despite days of standard therapy OR after failure of treatment after days of standard therapy OR if unable to tolerate standard therapy; patients with persistent human polymavirus type II (JC) virus infection will be eligible as well
Failure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any phase of standard therapy (any new lesion or an increase in size > % of a pre-existing lesion); patients may enter this study with or without re-induction therapy for recurrent tumor
Additional inclusion for part A: Has a histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.
Patients will undergo standard pre-transplant work-up as dictated by standard practice guidelines the results of which may be used for screening for this study
Disease that has progressed after standard therapies or for which standard therapy is otherwise unsuitable (example, intolerance).
Dose escalation: Patients with accessible tumors and with measurable disease as determined by RECIST . who have received at least one but no more than three prior lines of treatment for their disease and progressed despite standard treatment or are intolerant of standard treatment, or for whom no standard treatment exists
Dose expansion: Patients with advanced/metastatic solid tumors: head and neck squamous cell carcinoma (HNSCC), melanoma, accessible tumors and visceral tumors (LHC combination with PDR only). Patients must have measurable disease as determined by RECIST ., and have progressed despite standard treatment or are intolerant to standard treatment, or for whom no standard treatment exists and have received at least one but no more than three prior lines of treatment for their disease.
Patients with confirmed diagnosis of advanced malignancy, whose disease failed to respond to or progressed after standard therapy; they could not tolerate standard therapy; or such measures are not acceptable to the subject.
Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists.
Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist
Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist
Patient must have non-resectable disease that has progressed following standard therapy or has not adequately responded to standard therapy, or the patient must be intolerant to or have declined available standard therapies, or there must be no accepted standard therapy for their disease.
TUMOR BIOPSY SEQUENCING: Patients with histologically documented solid tumors whose disease has progressed following at least one line of standard therapy and/or no standard of treatment exists that has been shown to prolong survival
TREATMENT: Patients with histologically documented solid tumors whose disease has progressed following at least one line of standard therapy or for which no standard therapy exists that has been shown to prolong survival
Subjects must be diagnosed with a glioma, cholangiocarcinoma or other solid malignant tumor that has progressed despite standard therapy, or for which no effective standard therapy exists, with biopsy-confirmed evidence of an IDH or IDH mutation associated with neomorphic activity of the encoded proteins
Advanced or metastatic cancer for which no standard therapy exists or that has\n progressed despite standard therapy
STANDARD RISK PATIENTS:
DOSE ESCALATION PHASE: Histological or cytopathological diagnosis of an advanced cancer that is refractory to standard therapy or for which no standard therapy exists
Any standard therapy for leukemia within days before enrollment (except for hydrea)
Received at least one prior treatment with standard therapy (previous antibody\n therapy is acceptable)
Patients with histologically or cytologically proven advanced solid cancer and have undergone treatment with at least one regimen of standard therapy, either cytotoxic chemotherapy, a molecularly targeted agent, or immunotherapy, or have a form of cancer for which no standard therapy exists; patients with prostate cancer may continue on androgen-deprivation therapy if they are currently receiving it
Patients must have histologically proven solid tumors (Phase I) with biopsiable tumor (expansion cohort) refractory to standard therapy or for whom no standard therapy exists or who decline standard therapy
Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
Histologically or cytologically proven metastatic or locally advanced tumors for which no standard therapy exists, or where standard therapy has failed, or in patients otherwise ineligible for standard therapy, or for an indication that anti-programmed cell death protein (PD-) therapy has been shown to be effective in studies in HIV-uninfected participants; disease-specific criteria will be applied for certain common cancers and cancers strongly associated with HIV; however, enrollment will not be confined to these tumors
Phase I only: any (or no) prior therapy for metastatic disease is allowed, including cetuximab; if a patient has not received prior standard therapy, s/he must have been offered and refused prior standard therapy
Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
Patient must have received at least prior standard therapy for their disease
Subjects who have progressed on (or not been able to tolerate) standard anticancer therapy or for whom no standard anticancer therapy exists. Must have disease that is objectively measurable
Histologically or cytologically confirmed advanced solid tumors (excluding HCC) that have progressed following standard therapy, or for which no standard therapy exists (including surgery or radiation therapy) or participants with RR-DTC.
Has stable, or no evidence of, extracranial disease and not receiving systemic therapy for extracranial disease; Note: patients with stable disease must have already received standard therapy or are intolerant to standard therapy
Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST version ., who have progressed despite standard therapy or are intolerant to SOC, or for whom no standard therapy exists. Patients must fit into one of the following groups: CRC NSCLC TNBC RCC
Participants must have relapsed disease despite standard therapy
Diagnosis of advanced or recurrent, histologically or cytologically confirmed, solid malignancy that is either metastatic or unresectable. At time of enrollment, subjects either refuse standard curative or palliative therapy, are not candidates for standard curative or palliative therapy, have a disease for which no non-investigational therapy exists, OR have progressed on prior therapy (up to three lines of prior cytotoxic agents are permitted).
Patients must have received standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy
Patient with histologically-confirmed Stage IV malignant metastatic adenocarcinoma of the pancreas; (a) who has relapsed from or is refractory to standard therapy and for whom no therapy exists that would be curative or might provide significant benefit or (b) who are intolerant to or refuse standard chemotherapy and, therefore, for whom experimental therapy is a reasonable option.
Patient has a confirmed solid tumor diagnosis according to the following: a. Phase : patient has a recurrent or refractory solid tumor that has progressed or did not respond to standard therapy, or for which no standard anticancer therapy exists b. Phase : patient has radiologically documented measurable disease by RECIST . (for neuroblastoma, evaluable disease by MIBG/Curie score is also acceptable) in one of the following tumor types and has failed up to three lines of treatment i. Group : neuroblastoma ii. Group : rhabdomyosarcoma iii. Group : Ewing's sarcoma Phase portion or in preclinical studies
Part A only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.
Patients must have histologically documented solid tumors whose disease has progressed on standard therapy that is known to be associated with a survival advantage or have disease for which there is no known standard therapy
Patient has advanced solid malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
Failure to respond to standard therapy, or for whom standard therapy does not exist.
The participant has a histologic or cytologic diagnosis of a solid tumor (non-prostate, non-breast) that is metastatic and is refractory to or progressed (or relapsed) following standard therapies, or has disease for which no standard therapy exists; presence of metastatic bone lesion(s) is required
The patient is using an effective contraceptive (per the institutional standard), if procreative potential exists
Progressed or not tolerated standard therapy, and no further standard therapy is available
Show objective disease progression after the last administration of the last standard therapy or have stopped standard therapy due to intolerability (excluding ASPS subjects who have not received prior therapy) within months of enrollment.
Patients must have a histologically-confirmed metastatic or locally advanced cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy that increases survival by at least three months does not exist
In investigators opinion, no curative standard therapy exists
Part : Subjects with solid tumors that are refractory to, relapsed after or intolerant to standard therapy, or for whom no standard therapy exists or who are considered by the investigator to be inappropriate for standard therapy.
Tumor progression following at least one prior standard therapy
Patients for whom no standard curable therapy exists
Phase I: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by modified RECIST version . who have progressed despite standard therapy or be intolerant of standard therapy, or for whom no standard therapy exists, who have tumors harboring one of the following: confirmed PIKCA mutation or amplification, PTEN loss of function, EGFR mutation, cMET activation and/or HER overexpression. Endometrial carcinoma will not be selected for any molecular status.
Patients with locally advanced or metastatic solid tumors who have either relapsed following, or progressed through, standard therapy; have a current disease state for which there is no standard effective therapy; is not a candidate for, or is unwilling to undergo, standard therapy in cases where no curative option exists.
Advanced malignancy, metastatic or unresectable, that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists, or for which subject is not a candidate for, or is unwilling to undergo, standard therapy.
Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort ) or other solid tumor (Cohort ) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy
Patients must have either progressed on least one standard therapy or there must be no standard treatment exists that has been shown to prolong survival for the patients disease; patients may have received any number of prior cytotoxic agents
Diagnosis of teratoma for which no additional standard surgical or medical therapy exists
progressed or recurred despite standard therapy
no standard therapy exists
Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist
Patients must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, for which standard curative measures do not exist, that has progressed on at least one line of standard therapy or for which no standard therapies exists
Histologically- or cytologically-confirmed melanoma or clear-cell RCC that are refractory to standard therapy or for which no standard therapy exists
Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy.
Patients with cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists or patients with locally advanced or metastatic basal cell carcinoma who are not amendable or eligible for standard therapy.
Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
Tumors that are relapsed or refractory to at least prior anti-cancer systemic therapy and for which no standard therapy exists
Patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
RCC patients only: Tumor progression after receiving standard/approved chemotherapy and/or targeted agent, where there is no approved therapy or for tumors where sorafenib based therapy would be standard therapy (Phase I)
Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists. Only patients with tumors characterized by genetic abnormalities in ALK were enrolled.
Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy exists
Dose-escalation stage: Participants with histologically documented incurable, locally advanced, or metastatic epithelial malignancy that has progressed despite standard therapy or for which no standard therapy exists
Expansion stage: Participants with one of the following epithelial, histologically-documented, incurable, locally advanced, or metastatic tumor that has progressed despite standard therapy or for which no standard therapy exists: CRC, NSCLC, HNSCC, or pancreatic cancer
Must be planning to undergo standard radiation therapy.
Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists; exceptions: NSCLC, head and neck squamous cell cancer (HNSCC), bladder cancer, MSI-H/dMMR cancers and melanoma expansion cohorts in Part B pembrolizumab combination. ) Subjects must not have received more than prior lines of therapy for advanced disease including both standards of care and investigational therapies. ) Subjects who received prior anti-Programmed cell death protein (PD-)/ Ligand- (L) therapy must have received at least months of treatment (Part B and Part B).
Tumor for which prior treatment has proven to be ineffective or intolerable or for which no standard therapy exists
Phase I-Ib part (including dose ranging part): Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST v., who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists and who did not receive prior anti-PD-/PD-L treatment.
Phase II part (MBG single agent): Patients with advanced/metastatic solid tumors in the indication in which at least one confirmed PR or CR was seen during the dose escalation phase I part. Patients must have measurable disease as determined by RECIST v., have progressed despite standard therapy or be intolerant to standard therapy.
Phase II part (MBG in combination PDR): Patients with advanced/metastatic tumors in the below selected indications, with at least one measurable lesion as determined by RECIST v., who have received standard therapy and are intolerant of standard therapy or have progressed following their last prior therapy.:
Has progressed after prior therapy and either a) there is no further effective standard anticancer therapy available (including subject refusal) or b) is intolerant to standard anticancer therapy.
Histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator:
Participants with hepatocellular carcinoma or Intrahepatic Cholangiocarcinoma (ICC) who have progressed despite standard therapy or are intolerant of standard therapy
Confirmed locally advanced and/or metastatic solid tumor in participants who have progressed on a standard therapy, are intolerant to standard therapy, and/or are non-amenable to standard therapy
Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors that progressed to standard therapy or for whom no standard therapy exists: