Must not have received any prior radiation to any sites of measurable disease
Measurable or non-measurable (evaluable) tumor parameter(s); non-measurable tumor parameters will be defined as not having bi-dimensional measurements (i.e., gastric or marrow involvement) but can be followed for response by other diagnostic tests such as gallium, PET imaging and/or bone marrow biopsy
Patients must have measurable disease; all sites of disease must be evaluated within weeks prior to randomization
Patients must have measurable disease as defined by RECIST v. . criteria; baseline measurements and evaluation of ALL sites of disease must be obtained within weeks prior to registration
Measurable disease (defined by RECIST v. .) or evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST . definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease related in the setting of cancer antigen [CA] >= x upper limit of normal [ULN])
Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within weeks to registration
COHORT A: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectable; the decision to perform surgery on patients must be based on good clinical judgment; eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed completely resectable resulting in free surgical margins; patients must have residual disease after initial biopsy which can be measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) .; residual disease can either be confirmed with fine-needle aspiration (FNA) or if measurable disease is present, no FNA needs to be obtained OR
Patients must have newly diagnosed, stage IIA IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy
Have measurable disease based on RECIST . including at least two cancerous deposits; at least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT; non-radiated tumor will be identified prior to randomization on the protocol
Measurable disease and/or non-measurable disease\r\n* Measurable disease, defined as bidimensionally measurable lesions with clearly defined margins by magnetic resonance imaging (MRI) scans, with a minimum diameter of mm in both dimensions\r\n* Progressive disease required in cohort B, defined as any progressive measurable disease after surgery and radiation; progressive or recurrent disease is not required in cohort A, but is allowed provided it is a new diagnosis and patient has not received prior treatment
Measurable disease based on Cheson criteria
For patients with solid tumors, one of the following must apply: a. Patient has measurable disease as defined by the immune-related response criteria (irRC), b. Patient has ovarian cancer and has disease evaluable by CA- only
For patients enrolled in the Dose Escalation Phase, one or more tumors measurable on radiograph or CT scan, or evaluable disease defined as non-measurable lesions per RECIST v. . (e.g., malignant ascites). All patients enrolled to the Randomized Study Phase must have measurable disease only.
Patients may have measurable disease only, non-measurable disease only, or both (Response Evaluation Criteria in Solid Tumors [RECIST] .); concomitant treatment with bone-targeted therapies such as RANKL inhibitors or bisphosphonates is allowed; it is anticipated that most patients will have measurable disease, given the behavior of HER+ metastatic breast cancer
Measurable disease as defined by the tumor specific relevant response criteria for the breast and other solid tumor cohorts (measurable disease is not required for enrollment in the prostate cancer cohort):\r\n* RECIST version . criteria\r\n* Prostate Cancer Clinical Trials Working Group (PCWG) criteria\r\n* RANO criteria
Measurable disease, defined as any quantifiable monoclonal protein value
Progressive OR residual disease, as defined by the following:\r\n* Progressive disease, as defined as an increase in size of the measurable primary lesion on imaging by greater than % (bidirectional area); the change must occur between scans separated by no more than months\r\n* Residual measurable disease: for grade II or III meningioma, residual measurable disease immediately after surgery without requirement for progression; residual measurable disease will be defined by measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of mm in one dimension\r\n* Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease in the radiated field after completion of radiation; >= weeks must have elapsed from completion of radiation to registration; patients that have progressive disease outside of the radiation field do not need to wait weeks from completion of radiation
Patients must have active, measurable disease to be included in the study
Measurable disease by RECISTv. criteria
Radiologically measurable disease
Subjects must have radiographically measurable disease at the time of study enrollment to be eligible; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG)+ evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
Measurable disease, defined by the Lugano Classification Criteria
Measurable disease or non-measurable disease; for patients with non-measureable disease, they must also have a cancer antigen (CA)- measurement of > U/mL or X their documented nadir on separate measurements week apart
Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease; patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation\r\n* Measurable disease: patients must have measurable CNS disease, defined as at least one parenchymal brain lesion that can be accurately measured in at least one dimension with the longest diameter >= mm by local radiology review (measurable non-CNS disease is not required for study participation)\r\n* Patients will be defined as HER positive (+) if either the primary tumor and/or the metastasis are HER-positive, defined as + by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) >= .
Patients must have measurable residual disease, defined as tumor that is measurable in two diameters on magnetic resonance imaging (MRI); diffuse leptomeningeal disease is not considered measurable
Measurable disease, defined by the Revised Response Criteria for Malignant Lymphoma
Have disease that can be clinically evaluated for improvement or progression. In the dose-expansion phase of the study, subjects must have disease that is measurable, as defined by the RECIST Version . criteria for solid tumors (Eisenhauer et al, ) or the Lugano criteria for lymphoma (Cheson et al, ).
Measurable disease per the Lugano criteria
Must have evaluable or measurable disease; subjects with lymphoma must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma must be present; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
Patients must have measurable disease by the Lugano criteria
During dose escalation only, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to [>=] percent [%]) and/or plasmacytoma (>= centimeter [cm] in diameter) detected by physical examination or imaging.
For B-cell NHL subjects, measurable disease by imaging scan.
Participants must have measurable disease in at least one dimension of at least mm in diameter or thickness, according to modified RECIST for pleural malignant mesothelioma; bone metastases are not considered measurable; prior radiation to the only site of measurable disease will make the participant ineligible unless the lesion has been demonstrated to grow after completion of radiation therapy
Radiologically-measurable disease
Approximately out of patients with mCRPC enrolled must have measurable disease (approximately out of in each of the mCRPC Cohorts) that is suitable for repeated measurements. Enrollment will be monitored to ensure the required number of patients with measurable disease enter the study.
measurable disease based on central protein assessment
Measurable disease by physical examination or imaging as defined by RECIST v. criteria or evaluable disease as defined by Gynecologic Cancer Intergroup (GCIG) CA criteria.
Radiologically or visually measurable recurrent or metastatic disease that is measurable and at least mm in longest dimension.
Patients who have measurable disease after diagnostic biopsy
Patients must have radiographically measurable disease
Measurable disease (according to RANO guidelines)
Patients may have disease that is measurable or non-measurable but evaluable disease (e.g. present on bone scan, rising tumor markers, non-measurable by Response Evaluation Criteria in Solid Tumors [RECIST] but visible on computed tomography [CT] scan); patients with third space fluid (for example pleural effusions) as only site of disease will not be eligible
STRATUM A: Evaluable disease, as defined as meeting any of the following:\r\n* Patients who have measurable disease \r\n* Patients with radiologically discernible but non-measurable lesions (i.e. leptomeningeal disease)\r\n* Patients with cerebrospinal fluid (CSF) positive disease
STRATUM B: Evaluable disease, as defined as meeting any of the following:\r\n* Patients who have measurable disease \r\n* Patients with radiologically discernible but non-measurable lesions (i.e. leptomeningeal disease)\r\n* Patients with CSF positive disease
STRATUM C: Evaluable disease, as defined as meeting any of the following:\r\n* Patients who have measurable disease \r\n* Patients with radiologically discernible but non-measurable lesions (i.e. leptomeningeal disease)\r\n* Patients with CSF positive disease
Patients must have measurable or evaluable disease for the dose escalation portion of the study and measurable disease for the expanded cohort portion of the study (except for patients in the CNS metastases and leptomeningeal cohorts).
Patients must have radiographically measurable disease
Have measurable disease as per RECIST version .; at least of the tumor sites must be amenable to biopsy and this may not be the site of disease used to measure antitumor response
Measurable disease by RANO criteria
Patients must have measurable disease per irRECIST criteria for part (dose expansion)
Have measurable disease based on iwCLL or Lugano criteria
Measurable disease that can be accurately measured in at least one dimension as ? . cm with CT, ultrasound, or MRI techniques; extranodal disease that is measurable by FDG-PET imaging only will also be allowed; Note that if an excisional biopsy was performed that removed the sole site of measurable disease, the patient will not be eligible for leukapheresis and generation of CAR T cell product; measurable disease can be based on the imaging study done during the screening unless the patient received treatment in the interim, in which case imaging should be repeated
Measurable disease: for WM presence of monoclonal IgM immunoglobulin concentration on serum electrophoresis, with lymphoplasmacytic marrow infiltrate; for MZL: measurable nodal disease measuring at least . cm in longest dimension, or splenomegaly
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
Must have evaluable or measurable disease; subjects with lymphoma must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
Documented disease that is radiographically measurable
Have measurable disease based on irRECIST
Measurable disease by irRECIST
Measurable disease as defined by modified PCWG using iRECIST criteria
Measurable disease according to the Lugano classification
For dose escalation phase, patients may have evaluable or measurable disease. For ovarian cancer, if no measurable disease is present, patients should have assessable disease such as pleural effusion, ascites, with CA- Gynecological Cancer Intergroup (GCIG) criteria
Patients must have at least one focus of measurable metastatic disease
Radiographically measurable disease per mRECIST .
Must have measurable or evaluable disease during the dose escalation phase (measurable disease is preferred for the expanded cohort after MTD is reached).
Patients may have either measurable or non-measurable within of days of registration; (lesions treated with radiation therapy must not be used as a target lesion); (Note: per Response Evaluation Criteria in Solid Tumors [RECIST] criteria version [v.] ., measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension; non-measurable disease is defined as all other lesions, including small lesions [longest diameter < mm or pathological lymph nodes with P to < mm short axis] as well as truly non-measurable lesions; lesions considered truly non-measurable include: leptomeningeal disease, ascites, pleural or pericardial effusion, and inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques)
Patients must have measurable disease by Response Assessment in Neuro-Oncology (RANO) criteria at the time of registration (pre-operative)
Disease status: Subjects must have measurable or evaluable disease, by RECIST v. Curie Scale Criteria or RANO/RANO-BM
Have evidence of measurable or unmeasurable disease
Must have measurable disease as defined by irRECIST
Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) .; baseline measurements and evaluations must be obtained within < weeks of enrollment; disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy
Measurable disease is not required\r\n* Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within days prior to initial administration of drug\r\n* Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within days prior to initial administration of drug\r\n* Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease\r\n* If PSA is the only indicator of disease and patients do not have any metastatic disease, PSA value must be . or higher
Patients must have measurable disease; linear enhancement of leptomeningeal without measurable mass is excluded
Subjects must have measurable disease per Revised Response Criteria for Malignant Lymphoma
Measurable disease is not required\r\n* Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within days prior to initial administration of drug\r\n* Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within days prior to initial administration of drug\r\n* Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease\r\n* If PSA is the only indicator of disease and patients do not have any metastatic disease, PSA value must be . or higher
Measurable disease in at least non-radiated sites
INCLUSION CRITERIA FOR TNBC: Patients must have measurable disease by at least one of the criteria below:\r\n* Extra skeletal disease that can be accurately measured in at least one dimension as >= mm with conventional CT techniques as defined by RECIST .\r\n* Skeletal or bone-only disease measurable by FDG PET imaging
All patients must have measurable disease and tumors of sufficient sizes for biopsy; in general, liver and lung lesions should be at least . cm, and patients with lymph node-only disease should have lesions of >= . cm in shortest dimension; patients with disease confined to bone may be eligible if a measurable lytic defect is present; the study principal investigator (PI) is the final arbiter in questions related to measurability; patients with a three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease
Measurable disease by physical exam
JUST PRIOR TO FIRST VACCINATION (WITHIN DAYS): patients must have either measurable disease per Response Criteria in Solid Tumors (RECIST) version (v). or evaluable disease defined as an elevated tumor biomarker (CA-, carcinoembryonic antigen [CEA] or circulating free deoxyribonucleic acid [cfDNA] mutation); pancreatic cancer patients with an elevated tumor marker following a primary pancreatic surgery would be eligible
Measurable disease by RECIST criteria\r\n* For the lead-in, non-randomized portion of Part I, either measurable or evaluable disease is acceptable\r\n* For Part I, randomized portion, measurable disease is required
Solid tumors must have measurable disease (Recommended Phase Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
Measurable disease as defined by RECIST v. criteria. Baseline measurements and evaluation of ALL sites of disease must be obtained within weeks prior to Enrollment.
Have measurable disease based on RECIST . and immune related response (irRC) criteria
Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma
Patients must have evidence of metastatic disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease; Note: measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable mm soft tissue component that meets the measurability criteria per RECIST
Have measurable disease based on immune related response criteria (irRC) criteria
All patients must have measurable or evaluable disease; in general, liver and lung lesions should be at least cm, and patients with node-only disease should have lesions of >= . cm in greatest dimension; patients with disease confined to bone may be eligible if a measurable lytic defect is present or a serum marker is elevated (> x upper limit of normal [ULN]); the principal investigator is the final arbiter in questions related to measurability; patients with a three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease
Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within days prior to initial administration of drug
Soft tissue disease that has been radiated within the two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease
Patients enrolled in the main branch should have measurable disease; patients with a predominance of bone disease who have small, non-measurable or small measurable lesions other than bone, may be included per the principal investigators discretion, in the exploratory branch of the study for patients with bone metastases only
Participants do not need to have measurable disease at the time of radiation
Patient must have measurable disease as per RECIST version .; at least of the tumor sites must be amenable to biopsy and this may not be the site of disease used to measure antitumor response
Measurable disease by exam or CT scan, or for patients with cancer antigen (CA)- elevation or with microscopic residual but without measurable disease on imaging, willingness to undergo laparoscopy for evaluation of treatment effect if no radiographic progression after treatment cycles
Measurable or assessable disease according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., J. Clin. Onc., ); patients in complete remission with no evidence of disease are not eligible
Patients must have measurable disease per RECIST criteria . performed within days prior to enrollment. All other required tests to assess non-measurable disease must be performed within days prior to enrollment.
Radiologically measurable disease
Measurable or evaluable disease by RANO criteria (MRI) or Macdonald (CT) criteria
Patients do not need to have measurable disease at time of enrollment; patients with measurable disease must have stable disease by RECIST criteria on two scans at least weeks apart
Have measurable disease. Patients must have clinically and/or radiographically documented measurable primary disease according to RECIST .. At least one site of disease must be unidimensionally measurable. All radiology scans must be performed within days prior to registration
Evidence of measurable (macroscopic) residual disease following hysterectomy and lymphadenectomy
Patients with tumors other than DSRCT without measurable or evaluable disease will only be considered if they have < % chance of long term disease-free survival
Measurable disease as defined by RECIST v. or disease-specific criteria for prostate cancer and malignant pleural mesothelioma
Patients must have measurable disease (using modified Severity-Weighted Assessment Tool [mSWAT]) and/or use of indicator lesions must be designated prior to study enrollment (from imaging); measurable disease upon physical exam with a negative scan is acceptable
One or more tumors measurable on radiograph or CT scan, or evaluable disease defined as non-measurable lesions per RECIST or detection of protein M in serum and/or urine of patients with Multiple Myeloma (serum ? gm/L and urine ? mg/ hr).
Measurable disease as per IMWG response criteria
Radiographically measurable disease in the CNS documented ? weeks prior to starting E treatment
Presence of measurable disease as defined by: presence of immunoglobulin M (IgM) paraprotein, measurable lymphadenopathy on imaging studies and/or physical exam, and/or bone marrow infiltration > %
Measurable disease per modified Severity Weighted Assessment and/or Sezary count
Patients must have measurable disease in at least non-radiated sites as defined by RECIST v.; all sites must be evaluated within weeks prior to beginning therapy
Measurable disease is not required:\r\n* Patients who have measurable disease must have had X-rays, computed tomography (CT) scans or physical examinations used for tumor measurement completed within days prior to initial administration of drug\r\n* Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within days prior to initial administration of drug\r\n* Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease\r\n* If PSA is the only indicator of disease without any evidence of metastasis, PSA value must be . or higher
Have measurable disease based on immune-related response criteria (irRC)
Have measurable disease based on irRECIST .
Documentation of disease:\r\n* Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review\r\n* Molecular documentation: presence of SMO, PTCH or NF mutation in tumor sample as documented by central laboratory\r\n* Progressive OR residual disease, as defined by the following: \r\n** Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by % or more (bidirectional area); the change must occur between scans separated by no more than months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of mm in both dimensions\r\n** Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by % or more (bidirectional area); the change must occur between scans separated by no more than months\r\n** Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; at least weeks must have elapsed from completion of radiation to registration
Have measurable disease outside of biopsy site present per immune related (ir)RECIST criteria
Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). or elevated tumor markers (human chorionic gonadotropin [hCG], alpha-fetoprotein [AFP])\r\n* Note: patients without measurable disease are allowed on the study as long as they have clearly rising tumor markers and they will be exempt from biopsy
An additional eligibility requirement for phase II study includes the presence of radiographically measurable disease with the exception of MIBG-positive NB or NB with bone marrow involvement:\r\n* Measurable disease is defined as the presence of at least one solid lesion on MRI or CT scan that can be accurately measured with the longest diameter of at least mm in at least one dimension\r\n* Patients with NB who do not have measurable soft tissue disease but have MIBG-positive evaluable skeletal disease are eligible for phase II study\r\n* Patients with NB who have evidence of tumor cells in bone marrow are eligible for phase II study
Phase III study: evaluable disease - defined as RECIST . measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST . definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a cancer antigen [CA] >= x upper limit of normal [ULN])
Participants may have either measurable or non-measurable disease, but in all cases eligible patients must have disease that can be clinically evaluated for improvement or progression
Have measurable disease evident on radiographs (preferred) or clinical examination; for this protocol, measurable disease is defined as at least one evaluable tumor that is at least mm in longest dimension
Patients with M classic, non-desmoplastic medulloblastoma (R) with radiographically measurable residual disease < . cm^ are eligible
Patients may have additional measurable and/or non-measurable but radiographically visible metastatic lesions (e.g. bone metastases)
PHASE II: Patients must have measurable disease outside of the primary tumor (pancreas) by RECIST . criteria; baseline measurements and evaluations of all sites of disease must be obtained =< weeks prior to randomization
Disease status: stable disease or better at the time of enrollment
PHASE II: Patients must have measurable disease based on RECIST .; baseline measurements and evaluations of all sites of disease must be obtained =< weeks prior to registration
Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > cm is acceptable; lesions that are considered non-measurable include the following:\r\n* Bone lesions\r\n* Leptomeningeal disease\r\n* Ascites\r\n* Pleural/pericardial effusion\r\n* Inflammatory breast disease\r\n* Lymphangitis cutis/pulmonis\r\n* Bone marrow involvement (involvement by non-Hodgkin lymphoma should be noted)
Patients must have clear residual disease, defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) OR diffuse leptomeningeal disease OR clear MRI evidence of disease that may not be measurable in two perpendicular diameters
Measurable or non-measurable tumor parameter(s); non-measurable tumor parameters are defined as not having bidimensional measurements (e.g., gastric or marrow involvement), but can be followed for response by other diagnostic tests such as gallium, positron emission tomography (PET) imaging, and/or bone marrow biopsy
Measurable unresectable melanoma at least measurable lesion based on Immune-related Response Criteria (irRC)
Patients must have measurable advanced disease, that is not resectable by surgery; all sites must be assessed within weeks prior to randomization
Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; X-rays, scans or physical examinations used for tumor measurement must have been completed within days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within days prior to registration
Disease Related Criteria:
Presence of measurable disease by RECIST v. for solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL. For subjects with glioblastoma, presence of measurable disease is not required.
In the Phase portion of the protocol only, subjects must have measurable disease according to response criteria appropriate for their type of cancer (as explained in Section .).
Phase I (Cohort X): Participants with PIKCA-mutant tumors and measurable disease per RECIST v.
There must be residual disease
Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
Non-measurable disease: includes patients with symptomatic ascites or pleural effusions, lesions that do not meet RECIST criteria or biopsy proven recurrence; patients with clinically evident non-measurable disease must have either an elevated CA or histological confirmation of recurrence
measurable lymphadenopathy
The extramedullary plasmacytoma (EMP) sub-group, must have radiologically measurable EMP disease (soft tissue or bone related) that is amenable to biopsy and does not need to have measurable disease.
Measurable disease per the IMWG response criteria
Disease that is measurable as defined by RECIST v., mINRC, Revised Response Criteria for Malignant Lymphoma, RANO criteria (as appropriate) or evaluable by nuclear medicine techniques, immunocytochemistry techniques, tumor markers, or other reliable measures
Patients with a history of measurable disease as defined by RECIST criteria or bone only disease are eligible; Note: those patients with non-measurable disease and bone metastases are eligible
All sites of disease must be evaluated within weeks prior to randomization; patients must have measurable disease
For Parts B, C, D, E and F: Have measurable disease or reliable biomarker measure.
Patients must be at least weeks from prior thoracotomy (if performed); if prior thoracotomy then measurable disease on imaging must be present
Measurable disease, as defined by the Lugano Classification.
Measurable disease by RANO criteria at progression;
Subject should have stable disease for at least months on the current regimen with the last scans taken at least weeks apart; measurable disease is not required
Patients may have either measurable or non-measurable disease, but in all cases eligible patients must have disease that can be clinically evaluated for improvement or progression
For MM, Diffuse large B-cell lymphoma (DLBCL): Subjects must have disease that is objectively measurable, measurable levels of myeloma paraprotein in serum (> . g/dL) or urine (> . g excreted in a -hour collection sample) for MM and measurable disease by Internatonal Working Group (IWG) for NHL (with at least one measurable lesion's longest diameter ? cm).
At least one measurable lesion according to the International Working Group Response Criteria for Lymphomas; there must be measurable lymphadenopathy to follow with serial exam and/or imaging
Previous exposure to murine CA- antibody (only applicable to those patients with non-measurable disease by RECIST)
Histological confirmation of disease with documented disease relapse after the last therapy requiring treatment per the treating physician. Participants with lymphoma must have at least measurable site of disease (Part only). In addition, B-cell malignancy disease-specific criteria specified in the protocol must also be met
Measurable disease, as defined by the International Harmonization Project
Have either measurable disease or nonmeasurable bone-only disease
Bidimensional measurable disease
Measurable or evaluable disease, as defined in Revised Response Criteria for Malignant Lymphoma; baseline scans used for measurement should be obtained within days of registration, and baseline bone marrow biopsy and/or aspiration should be obtained with days of registration
Patients with at least one measurable skin metastases and distant, measurable metastases (outside of skin) by Response Evaluation Criteria in Solid Tumors (RECIST); for patients without distant measurable metastases, an area of the skin metastases designated to not receive local therapy can be substituted; patients with multiple (>= ) metastatic sites (skin involvement not required), with at least one site measurable by RECIST, will be eligible for the CTX/RT cohort
Patients must have at least one objective measurable disease parameter; baseline measurements and evaluations must be obtained within weeks of registration to the study; abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging; measurable disease in the liver is required if the liver is the only site of lymphoma; if the only radiographically assessable disease is splenomegaly (without discrete measurable nodules), the patient can be enrolled, but for such patients CR cannot be differentiated from PR, while the spleen will be considered nodal with respect to criteria for progressive disease (PD)
Disease that is measurable by standard imaging techniques per RECIST and immune-related response criteria (irRC; all tumor types except lymphoma) or International Working Group (IWG) revised response criteria for malignant lymphoma (lymphoma only). For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field(s), unless disease progression has been documented at that disease site subsequent to radiation.
Disease and disease status:
Measurable disease by RECISTv. criteria
Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible
Patients must have radiographically measurable disease
MCL patients must have:\r\n* At least measurable site of disease according to Revised Response Criteria for Malignant Lymphoma\r\n* Received at least prior standard therapy for MCL
Have measurable disease based on irRECIST (Safety expansion only)
Patients should have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) .; if no measurable disease is present, patients should have assessable disease such as pleural effusion, ascites, with cancer antigen (CA) Gynecological Cancer Intergroup (GCIG) criteria
Subjects must have ? measurable disease sites
Have either measurable disease or nonmeasurable bone only disease
At least measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
All patients must have measurable residual disease defined as tumor measurable in two perpendicular diameters on magnetic resonance imaging (MRI); measurements are required for both the solid and cystic components
Subjects must have clinically or radiographically evident measurable disease at nodal stations
At least measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
Evidence of metastatic disease with measurable lesion(s) as defined by RECIST guideline version . to permit tumor response evaluation; subjects with unresected primary tumors may be enrolled as long as evidence of measurable metastatic disease is also present
Patients must have at least one site of measurable disease (if applicable) (per RECIST for solid tumors or the appropriate disease classification/criteria for the target population)
Patients must have measurable disease, documented by clinical and radiographic criteria
Recurrent NSCLC: Defined as the re-appearance of measurable disease, or the appearance of new measurable disease by RECIST Criteria after prior successful treatment or complete response.
Refractory NSCLC: Defined as achieving less than a complete response and having residual measurable disease by RECIST criteria after prior treatment with chemotherapy, targeted or small molecules, monoclonal antibodies or any combination of these.
DISEASE AND PRIOR STATUS CRITERIA:
Measurable or evaluable disease, as defined in Revised Response Criteria for Malignant Lymphoma
Measurable disease is required; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= mm with conventional techniques or as >= mm with spiral computed tomography (CT) scan; bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses identified by physical exam that are not measurable by reproducible imaging techniques, and cystic lesions are all considered nonmeasurable; as of //, the evaluable/non-measurable cohort has been filled and only patients with measurable disease are allowed moving forward; prior to //, up to % of patients entered on this trial (i.e. patients) were entered with evaluable but nonmeasurable disease
Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable
Measurable disease, defined by the revised lymphoma criteria (Cheson )
For Parts A and G: Have measurable or nonmeasurable disease
For Parts B, C, D, E and F: Have measurable disease
Patients with lower M-protein values or non-secretory myeloma will be eligible if measurable disease can be established, such as serum FreeliteTM chain ratio >x ULN, measurable soft tissue plasmacytoma >cm by either physical exam and/or applicable radiographs (i.e. MRI, CT-scan) and/or bone marrow involvement >%
Patients must have measurable radiographic disease; patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease
Patient on the dose-escalation portion of the trial must have evaluable disease, defined as either measurable (by Response Evaluation Criteria in Solid Tumors [RECIST]) or non-measurable disease (e.g. bone mets, pleural effusion or lymphangitic spread); measureable disease is required for patients in the expanded RPD cohort
Patients with (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
Evidence of measurable disease either by RECIST . or elevation of serum tumor markers (AFP > ng/mL or HCG > . mIU/ml)
All patients must have measurable or evaluable disease. In general, liver and lung lesions should be at least cm, and patients with node-only disease should have lesions of >/= . cm in greatest dimension. Patients with disease confined to bone may be eligible of a measurable lytic defect is present or a serum marker is elevated (> x ULN). The Study Chairman is the final arbiter in questions related to measurability. Patients with a three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease.
Presence of measurable tumor
At least measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
Presence of measurable lymphadenopathy
Patients with T-cell LL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis. Patients with T-cell LL enrolled in the phase I dose-escalation study are not required to have measurable disease; however, patients enrolled in the phase II cohort expansion at the MTD must have measurable disease.
Measurable disease according to the Lugano Classification
Must have ? measurable disease sites as defined by standard Lugano classification.
During the escalation phase of the protocol, patients may have evaluable or measurable disease; during the expansion phase of the protocol, patients must have ) measurable disease, ) disease amenable to biopsy and ) willingness to undergo pre- and post-treatment biopsies
Presence of measurable lymphadenopathy
Presence of clinically and/or radiologically documented disease. At least one site of disease (which will not be removed during the course of the study) must be uni-dimensionally measurable as per RECIST . or clinically quantifiable (such as in the case of skin disease)
Radiologically measurable disease by immune-related Response Criteria (irRC).
Applicable disease criteria
Radiologically measurable disease
All patients must have no measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of imaging techniques. Imaging must be done within weeks of study entry.
Measurable disease will be required; biopsiable disease will be required
Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
For expansion: documentation by established staging studies or clinical examination to have measurable metastatic disease per RECIST v. criteria
Patient must have measurable disease per RECIST . presented after tumour biopsy for the late disease progression
Patients may have measurable or nonmeasurable but evaluable disease; patients with surgically resected metastatic disease at high risk of relapse are also eligible
Measurable tumor lesions according to RANO working Group Criteria. a. In the case that there is \non-measurable\ disease due to a radical surgical resection during screening, the subject still qualifies if Inclusion #(b) is met.
Patients must have measurable disease as defined by immune-related complete response (irRC) (Wolchok, ); all sites must be evaluated within weeks prior to beginning therapy
Evaluable disease. In the absence of lymphadenopathy, splenomegaly with defects or measurable extra-medullary disease is acceptable
May be treated with localized radiation as long as measurable or evaluable disease remains at untreated sites.
Measurable disease based on Cheson criteria
At least one measurable lesion according to international workshop lymphoma response criteria; there must be measurable lymphadenopathy to follow with serial exam and/or imaging
Patients must have measurable disease as defined by revised RECIST criteria (version ., Appendix C) with one or more lesions that can be accurately measured in one or more dimensions within weeks of entry. Areas of previous radiation may not serve as measurable disease.
Measurable Disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > cm is acceptable; lesions that are considered non-measurable include the following:\r\n* Bone lesions\r\n* Leptomeningeal disease\r\n* Ascites\r\n* Pleural/pericardial effusion\r\n* Inflammatory breast disease\r\n* Lymphangitis cutis/pulmonis\r\n* Bone marrow involvement (involvement by non-Hodgkin lymphoma should be noted)
Part A: Have the presence of measurable or nonmeasurable disease as defined by the RECIST v. (Eisenhauer et al. ) or Revised Response Criteria for Malignant Lymphoma (Cheson et al. ) or have measureable disease for multiple myeloma.
Radiologic eligibility (measurable disease) must be must be confirmed by the BICR prior to randomization.
Has measurable or nonmeasurable disease
Have the presence of measurable or nonmeasurable disease
Patients must have measurable disease; patients may or may not have cancer-related symptoms
Bidimensionally measurable disease (field not previously radiated)
Measurable evidence of active disease within year before study enrollment
Symptomatic MM, based on IMWG guidelines. Patients must have measurable disease.
COHORT A SPECIFIC INCLUSION: Measurable disease on imaging ( cm) or measurable non-enhancing tumor
Measurable disease per IWG criteria.
Patients with no active disease; (as defined as no detectable disease)
Measurable disease as defined by mINRC, RANO, RECIST v., or evaluable by nuclear medicine techniques, immunocytochemistry, tumor markers, or other reliable measures
Measurable disease on preoperative imaging
Patients who have measurable disease after diagnostic biopsy
Measurable disease as per IMWG response criteria
Disease may be measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] . criteria) or non-measurable but must be present in at least one non-liver site, where presence is defined as . cm or greater and visualized on PET/CT with [F]-fluorodeoxyglucose (FDG); patients with effusion only disease or disease only in the liver are not eligible for the study
Disease may be measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] . criteria) or non-measurable but must be present in at least one non-liver site, . cm or greater and visualized on PET/CT with [F]-fluorodeoxyglucose (FDG). Patients with effusion only disease or disease only in the liver are not eligible for the study.
Disease that is either:\r\n* Radiologically-measurable or evaluable as define by tumor response criteria from and MSKCC-Institutional Review Board (IRB) approved clinic research protocol\r\n* Detectable by biopsy (eg, bone marrow) and/or peripheral blood assays obtained within weeks of study enrollment
Patient must have measurable residual disease, defined as tumor that is measurable in two perpendicular diameters on MRI; diffuse leptomeningeal disease is not considered measurable
Have measurable disease based on irRECIST
Measurable disease (assessed within days prior to day )
For patients enrolling once escalation is complete, disease must be measurable per RECIST . criteria with last imaging performed within days prior to first drug dose In addition to the criterion listed above, Patients in Phase a must have a histologically- or cytologically-confirmed, advanced or metastatic solid tumor, in of the following categories: disease history specificied in one of the criteria listed below:
Radiographic evidence of unidimensionally measurable disease; lesions will be considered measurable or non-measurable as per definitions provided in RECIST version .
Part , Dose Escalation: Participants may have measurable or non measurable disease as defined by RECIST ./mRECIST (depending on tumor type).
Relapse/progression based solely on elevation of CA-, in absence of measurable disease, according to irRECIST criteria.
Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or physical examination. In phase II, measurable disease as per Response Evaluation Criteria in Solid Tumors [RECIST] . is mandated. In phase Ib, patients with or without measurable disease are eligible.