Patients with newly diagnosed, unresectable, metastatic and measurable ASPS will also be eligible if they show clinical evidence of disease progression (including history and increasing physical symptoms); on-study documentation will include a physicians rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain)
Elevation in tumor markers without radiographic evidence of disease progression is not satisfactory for progression on previous treatment
Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment
Prior use of ibrutinib is allowed unless patient has had disease progression while receiving ibrutinib
A patient may not participate in a concurrent treatment protocol; all patients will be eligible to receive chemotherapy alone, systemic therapeutic agents, or conventional chemo-radiotherapy at the time of clinical or radiographic disease progression or at weeks following completion of SBRT
Patients must have confirmed progression during or after treatment with either nivolumab or pembrolizumab. Confirmed progression is defined as:
Radiological progression (confirmed at least weeks after the initial scan showing PD); or
Progression on at least one prior systemic therapy or progression during an observation phase of no anti-cancer therapy within the prior months; prior taxanes are allowed
In dose escalation (Phase I), patients must have histologically or cytologically confirmed metastatic disease from any solid tumor that is incurable and fulfills one of the following criteria:\r\n* Has demonstrated progression of disease following at least one line of effective systemic therapy; prior treatment with anti-CTLA- antibody (including ipilimumab) is allowable OR\r\n* For which effective therapy does not exist
One of the following must be true:\r\n* Distant disease progression during administration of combination therapy with taxane based chemotherapy and anti-HER therapy (trastuzumab or pertuzumab) for metastatic disease; note: patients who began treatment with this combination and discontinued taxane-based chemotherapy due to intolerability before distant disease progression are eligible\r\n* Distant disease progression during administration or within days of discontinuing combination therapy with taxane based chemotherapy and anti-HER therapy (trastuzumab or pertuzumab) in the adjuvant disease; note: patients who began treatment with this combination and discontinued taxane-based chemotherapy due to intolerability before distant disease progression are eligible\r\n* For patient who received taxane based chemotherapy and anti-HER therapy (trastuzumab or pertuzumab) in the neo-adjuvant setting and underwent surgical resection of primary breast disease: distant disease progression during or within days of discontinuing anti-HER therapy (trastuzumab or pertuzumab) in the adjuvant setting
Disease progression within months after the last treatment.
Prior ACT therapy should be completed, and residual disease documented by either radiographic progression or active disease observed on biopsy (i.e. hematologic or solid tumor malignancy must be deemed active by the treating investigator); the investigator may deem that the disease is active on the basis of a pre-treatment biopsy demonstrating viable tumor cells or clinical progression of disease (i.e. RECIST progression is not required)
Documented disease progression within months prior to study registration, as defined by RECIST criteria
Documented radiographic or clinical disease progression on no more or less than one previous line of standard therapy
Received prior treatment with AZD (osimertinib) or CO (rociletinib) and experienced disease progression.
Disease progression at study entry
Must have shown disease progression according to RECIST, version ., following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression according to RECIST, version ., within months of the last dose are considered to have received chemotherapy in the metastatic setting. These subjects will be referred to as chemo-refractory subjects. (Subjects who have shown disease progression according to RECIST, version . following prior treatment with anti-Programmed death-ligand (anti PDL/PD) antibodies are also eligible)
Patient after progression with to imatinib at the dose of mg as first line treatment. Resistance Progression is defined as a RECIST . and/or CHOI disease progression while receiving imatinib treatment
Progressive disease on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of participants from study TDMg (NCT) with early disease progression who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
Must have radiographic disease progression after at least line of systemic cytotoxic therapy for metastatic disease or with progression within months of completing adjuvant chemotherapy.
All patients must have experienced disease progression on or after their most recent systemic therapy.
Patients that have had prior treatment must show disease progression during or following the last treatment according to RECIST . criteria.
Confirmed radiologic disease progression during or following recent treatment
experienced disease progression during or after prior first-line regimen for metastatic disease
Evidence of tumor progression on or after the last treatment regimen received and within months prior to study enrollment
Has MM defined by the IMWG criteria with evidence of disease progression and:
At least one previous treatment for WM with either documented disease progression or no response (stable disease) to the most recent treatment regimen
Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within months prior to study enrollment; this assessment is performed by the treating investigator; evidence of progression by RECIST criteria is not required
Documented radiological evidence for disease progression (measurable or nonmeasurable) =< months prior to enrollment
Radiologic evidence of disease progression within months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy
Patients on either treatment arm will considered for crossover if they demonstrate evidence of radiographic disease progression from the initial treatment
Patients must evidence of disease progression, either clinically or radiographically, within the weeks prior to study enrollment, as determined by the investigator enrolling the patient on the study
Randomization within days of diagnosis of last progression
Must have evidence of progressive disease with biochemical (i.e. rising CA-) and/or radiologic progression
Documented disease progression per RECIST v.. during or immediately after last therapy according to any of the aforementioned criteria.
Radiologically confirmed disease progression
Evidence of relapse or progression of hematologic malignancy at the time of study enrollment.
Relapse or progression after at least systemic therapy
Disease progression (AD worse) in non-risk organs at any time during continuation treatment
Documented disease progression following prior therapy, as assessed by the Investigator.
Patients must have evidence of disease progression prior to enrollment
Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be a candidate for therapy of proven efficacy for their disease due to an underlying physical condition
Subjects must have demonstrated either tumor progression or recurrence by any of the radiographic criteria and/or clinical criteria as defined below:\r\n* Subjects with progressive non-resectable disease regardless of location in the brain or spine are eligible for this study; patients with evidence of leptomeningeal dissemination are eligible for this study; patients do not require biopsy/histologic confirmation at the time of progression or relapse\r\n* Radiographic progression is defined as > % increase in the product of the three perpendicular diameters of current tumor relative to the baseline measurement (defined as either the initial scan or scan at start of a previous therapy): length (L) x width (W) x transverse (T) (current scan) > . x L x W x T (baseline scan), or the development of any new sites of disease independent of the response of the initial tumor\r\n* Post radiation changes are often seen on post-treatment imaging studies, so that classification of a patient as having progressive disease may require several serial magnetic resonance imaging (MRI)s if the child has received radiation within the preceding months\r\n* Tumor volume includes the entire tumor volume seen on gadolinium enhanced T magnetic resonance (MR) imaging plus non-enhancing abnormality seen on T or fluid attenuated inversion recovery (FLAIR); coronal and axial images will be evaluated\r\n* All tumor cysts will be included in the tumor volume\r\n* Clinical progression without radiographic progression includes children with optic pathway gliomas who demonstrate sustained decrease in visual fields and/or acuity in three serial vision examinations; each of the vision examinations must be performed > weeks apart\r\n* Children with previously negative cerebrospinal fluid (CSF) cytology who show evidence of tumor cells in fluid obtained by lumbar puncture can be designated as having progressive disease in the absence of radiographic evidence of progression
Patients must have radiologic evidence of disease progression
Radiographic, biochemical, or clinical evidence of tumor progression over a period of up to months in at least one site
Evidence of disease progression at the time of enrollment
Radiologically documented disease progression on previous osimertinib treatment.
Radiologically documented disease progression on or after most recent antitumor therapy.
Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
Radiographic evidence of progression/recurrence of the measurable disease more than weeks after the end of initial radiation therapy
Patients with disease progression prior to enrollment
Patients must have recurrence or progression of their low-grade glioma after coming off treatment with AZD on PBTC- or PBTC-B, with or without having received additional anti-tumor therapy following discontinuation of AZD; the progression must be unequivocal and sufficient to warrant re-treatment in the opinion of the investigator; progression will be defined as either progressive disease (PD) that meets the study definitions of progressive disease by MRI or vision deterioration thought to be related to tumor in patients with optic pathway tumors
Tumor progression after radiation
Disease progression by IWG criteria since last therapy
Progression of disease
Adult patients stage IV lung cancer or melanoma receiving commercial supply immune checkpoint inhibitor therapy with progression of disease, and for whom an additional - weeks of current therapy (post-progression therapy) is acceptable as standard therapy
Have evidence of radiographic disease progression with scan documenting progression occurring within weeks of signing informed consent
Has radiological documentation of disease progression while receiving continuous treatment with erlotinib, gefitinib, or afatinib.
Patients must have experienced disease progression within months prior to study registration or experienced intolerable side effects on a tyrosine kinase inhibitor. No progression is required for patients with anaplastic thyroid cancer.
Documented failure to achieve at least PR with, or documented disease progression after, the most recent treatment regimen.
Documented disease progression or intolerance to treatment either during or after treatment with most recent therapy
Progressive disease by RECIST . with or without symptoms within the last months; NOTE: untreated patients with existing histologic diagnoses are eligible if progression can be demonstrated
For the expansion cohort: patients must have had disease progression on alectinib (including patients who received alectinib as first-line treatment); subsequent anti-neoplastic therapy (including other ALK inhibitors or chemotherapy) after progression on alectinib is not permitted; Note: patients in the dose-finding portion of the study may have received other anti-neoplastic therapy after progression on alectinib
Patients who have received previous treatment with T-DM and had systemic progression of disease while on it, are ineligible; patients receiving treatment with TDM whose only site of disease progression was brain are allowed to enroll in this trial
Soft tissue disease progression as defined by RECIST ..
Patients must have evidence of disease progression and cannot be a candidate for surgical treatment or radiation\r\n* NOTE: Disease progression is defined as one of the following occurring within the months prior to study entry:\r\n** At least a % increase in radiologically or clinically measurable lesions\r\n** Appearance of any new lesions or\r\n** Symptomatic and/or deterioration in clinical status
Patients who were previously exposed to zydelig and experienced progression of disease
Progressive disease: GIST has demonstrated progression as defined by RECIST v. within the past months; patients whose tumors do not meet this criterion, and have a diagnosis of NF, may enroll on the NF natural history study
(For cohort A): No limit on prior therapies for metastatic disease. (Relapse of disease within months of adjuvant or neoadjuvant chemotherapy is considered line of therapy for metastatic disease). (For cohort B): received at least one dose of an anthracycline-based NACT. Patients are eligible if therapy was discontinued due to disease progression or therapy intolerance. Patients with disease progression on anthracycline-based therapy should be evaluated by the surgical team. If the patient is deemed inoperable at the time of evaluation, the patient may continue to undergo protocol therapy with a goal of reduction in tumor size to become operable. If the patient is deemed at high risk of becoming inoperable by the surgical team based upon tumor size or location, the patient will be considered ineligible for study and will be recommended to go to surgery
Must have radiographic disease progression after line of systemic cytotoxic therapy for metastatic disease or with progression within months of completing adjuvant chemotherapy
Radiographic or clinical disease recurrence or progression during or after the last line of systemic therapy
Patients may be maintained on hormonal therapy provided there is clear evidence of tumor progression
Progression following standard combined modality treatment with radiation and temozolomide chemotherapy
Received systemic multiple myeloma therapy post-relapse/progression; patients that received - cycles of salvage therapy, local radiation, and/or corticosteroids post-relapse/progression are eligible if there was no further disease progression following administration
Disease progression by IWG Working Group or ICML criteria since last therapy
Patients with SSc as defined by the American College of Rheumatology with diffuse cutaneous disease (except Group ) at risk of disease progression
Patients must have radiological evidence of disease progression following the most recent treatment
There must be evidence of progression on or after last treatment regimen received and within months of enrollment
Radiographic or clinically measurable evidence of disease progression
Progression of disease by radiographic imaging (% increase in size by RECIST version [v]. within months of registration) or presence of new lesions
Documented progression of disease on at least one -FU-based regimen and at least one GEM-based regimen for metastatic disease (progression during or within months of the completion of adjuvant therapy is acceptable)
In the opinion of the investigator and confirmed by the Millennium medical monitor, the participant may continue to benefit from treatment with ixazomib (eg, response to therapy or stable disease without evidence of disease progression).
Radiographic disease recurrence or progression during or after the last line of chemotherapy
Subjects who have undergone at least six months of chemotherapy without radiologic progression of the tumor burden
Patients must have biopsiable disease at the time of enrollment as biopsies after progression are required for participation
Patients must be three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression
PHASE II SCLC: Radiographic evidence of disease progression after initial therapy should have been documented
Failure to respond to standard therapy, or for whom standard or curative therapy does not exist, or is not tolerable. a. Subjects enrolled in the Expanded Cohort should have no more than prior systemic regimens with confirmed disease progression. If the subject is refractory or has disease progression within months of the adjuvant treatment, then the previous treatment should be considered as the line of treatment rather than an adjuvant therapy.
Patients must ? weeks from radiotherapy, to minimize the potential for magnetic resonance imaging (MRI) changes related to treatment (pseudo progression) that might be misdiagnosed as true progression of disease, unless the patient fulfills criteria for early progressive disease by RANO.
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: Patients must have completed standard radiation therapy with concurrent temozolomide (TMZ) within (weeks) wks of enrollment and must not have evidence of progressive disease on post treatment imaging; progression can only be defined using diagnostic imaging if there is new enhancement outside of the radiation field (beyond the high-dose region or % isodose line) or if there is unequivocal evidence of viable tumor on histopathologic sampling(e.g., solid tumor areas [i.e,> % tumor cell nuclei in areas], high or progressive increase in mindbomb homolog [MIB-] proliferation index compared with prior biopsy, or evidence for histologic progression or increased anaplasia in tumor); Note: given the difficulty of differentiating true progression from pseudoprogression, clinical decline alone, in the absence of radiographic or histologic confirmation of progression, will not be sufficient for definition of progressive disease in the first weeks after completion of concurrent chemoradiotherapy
No evidence of disease progression: defined as increase in tumor size of > % or new lesions
Symptomatic metastatic disease with signs of rapid progression per investigators clinical judgment
Documented disease progression (as per RECIST v.) before study entry; for patients with osteosarcoma, this progression will be confirmed by central review on the basis of two CT scan or magnetic resonance imaging (MRI) obtained at less than months in the period of months prior to inclusion
Evidence of progression of disease as defined by RECIST . (i.e. new disease sites or % growth of index lesions) within months of registration
Patients with clear cell histology must have demonstrated: ) progression on at least one prior anti-angiogenic agent unless intolerable; AND ) progression on at least one agent that blocks the PD- pathway unless felt by the treating physician to be contraindicated (examples include but are not limited to: patients with autoimmune disease or patients requiring systemic steroids greater than mg/day prednisone or its equivalent) or if they have been discontinued due to toxicity; prior rapalogues are allowed
Subjects who experience a disease response per RECIST . criteria followed by subsequent progression will be required to have a post-treatment biopsy if feasible and safe
Must have evidence of either RECIST . defined disease progression or stable disease year after initiating nivolumab therapy
Failure of at least one line of systemic anti-cancer therapy for advanced NSCLC defined as either of the following: \r\na) Radiological documentation of disease progression (or failure to achieve a response) or \r\nb) Discontinuation due to toxicity
Patient must not have clinical evidence of disease progression prior to the CD+ memory T-cell infusion
Progression following platin, -FU, cetuximab and taxane given for incurable disease
B-cell (B)-chronic lymphocytic Leukemia (CLL)\r\n* Relapse/progression after two previous regimens\r\n* No response or progression =< months after fludarabine (fludarabine phosphate) or bendamustine based regimen\r\n* Progression within months of a fludarabine and alkylator combination regimen\r\n* Progression after any regimen in the presence of deletion (del)p or mutated tumor protein p (TP)\r\n* Persons with high grade lymphoma transformation
Cutaneous T-cell lymphomas (mycosis fungoides, Sezary syndrome)\r\n* >= stage III\r\n* Disease progression >= prior regimens, including at least one systemic therapy
Radiographic evidence of progression/recurrence of the measurable disease more than weeks after the end of the initial radiation therapy
COHORT A: Patients must have progressive disease, defined as the presence of new or growing lesion(s) on radiologic imaging within months of study enrollment and/or new/worsening disease related symptoms within months of study enrollment; (progression according to RECIST v . criteria is not required)
Willingness to forego additional therapy until evidence of disease progression
Patients with evidence of disease progression post SCT at the time of consideration for the study enrollment will not be included
Evidence of progression or lack of response following at least prior treatment for indolent lymphoma
Patients must have had disease progression on or following their most recent treatment regimen or on presentation for the first time with metastatic disease
Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
Patients who have evidence of disease progression before day after ASCT
Participants must be otherwise indicated for radiation therapy independent of this study:\r\n* For low-grade gliomas, typical indications would include at least one of:\r\n** Progressive or recurrent disease as defined by imaging\r\n** Persistence or progression of neurological symptoms (e.g., seizures), or\r\n** At risk of early progression as defined by either (a) age >= , (b) mindbomb homolog (MIB-) >= %, or (c) size > cm and/or of limited resectability\r\n* For favorable grade III gliomas, typical indications would be at upfront diagnosis following maximal safe surgery or a recurrence of a lower grade tumor with metaplastic evolution to grade III disease
Evidence of disease progression defined by progressive VS growth during the previous months (> % increase in volume, as clinically determined) in all patients; usually patients with disease progression proceed to microsurgical resection, however for those patients who are at increased risk for surgical complications (e.g., deafness, lower cranial nerve injury, facial weakness) or who refuse surgery, enrollment in the study may be the best clinical option
Disease progression or relapse prior to HPC infusion
Documented disease progression on or after prior systemic treatment administered for the advanced disease including CYP inhibitors and/or androgen-pathway inhibitors (i.e. abiraterone and/or enzalutamide when available) and no more than one line of chemotherapy for the advanced disease, or patients who were ineligible (unfit) to receive chemotherapy. Disease progression defined as increasing serum PSA (per PCWG), radiological progression or ? new bone lesions. (Chemical castration is required unless surgically orchiectomized.)
Participants must have completed cycles of a bortezomib-based induction regimen (as defined by current NCCN guidelines) and have no evidence of disease progression as defined by IMWG criteria.
Radiographic demonstration of disease progression following prior therapy
Patients must have documented radiological disease progression either during or after the first-line therapy.
Received either IPI- or ofatumumab while participating in study IPI-- and experienced radiologically-confirmed disease progression
Has had documented disease progression on or within days after completion of the last therapy.
Must have documentation of no evidence of disease progression of the tumor during or after completion of first line systemic anti-cancer therapy
Patients must have completed standard radiation therapy with concurrent TMZ and must not have evidence of progressive disease on post treatment imaging. Progression can only be defined using diagnostic imaging if there is new enhancement outside of the radiation field (beyond the high-dose region or % isodose line) or if there is unequivocal evidence of viable tumor on histopathologic sampling (e.g., solid tumor areas [i.e, > % tumor cell nuclei in areas], high or progressive increase in MIB- proliferation index compared with prior biopsy, or evidence for histologic progression or increased anaplasia in tumor). Note: Given the difficulty of differentiating true progression from pseudoprogression, clinical decline alone, in the absence of radiographic or histologic confirmation of progression, will not be sufficient for definition of progressive disease in the first weeks after completion of concurrent chemoradiotherapy. (For Stage : Post-chemoradiation group only)
Ultimate progression through previous treatment with cetuximab, with documented clinical progression; patients who discontinued cetuximab for any other reason, such as decline in performance status, hypersensitivity, or other adverse effects of therapy, are not eligible
In the case of malignant glioma patients, they must have previously undergone standard-of-care treatment including surgery, radiation, and first line adjuvant chemotherapy prior to the experimental treatment (WP); in the case of melanoma patients with brain metastasis, they may have previously undergone a resection (with radiographic evidence of progression), have undergone gamma knife radiosurgery (with radiographic evidence of progression), or have been treated with other systemic therapies that failed
Clinical or radiographic evidence of disease progression
Radiological documentation of disease progression:
Well-differentiated NET group: Disease progression while on/or after the last treatment, and this progression must have been observed within months prior to start of study treatment (i.e. maximum of weeks from documentation of progression until study entry). Disease must show evidence of radiological disease progression based on scans performed not more than months apart.
Poorly-differentiated GEP-NEC group: Disease progression while on or after prior treatment.
The subject must have stable disease after treatment of radiation with concurrent chemotherapy or in case of progression that the disease is controlled with another treatment type
For subjects with glioma, specific inclusion criteria are as follows:\r\n* The disease should be recurrent or transformed glioma; subjects must not have had prior surgery (biopsy allowed) or radiation therapy within weeks of enrollment\r\n* There must be an enhancing component of disease, as evaluated on pre-treatment magnetic resonance imaging (MRI)\r\n* For patients with World Health Organization (WHO) grade III or IV glioma and progressive disease < weeks after completion of chemoradiotherapy, progression can be defined by the following set of criteria:\r\n** New enhancement outside of the radiation field (beyond the high-dose region or % isodose line)\r\n** If there is unequivocal evidence of viable tumor on histopathologic sampling (e.g., solid tumor areas. i.e., > % tumor cell nuclei in areas), high or progressive increase in MIB- proliferation index compared with prior biopsy, or evidence for histologic progression or increased anaplasia in tumor);\r\n** Note: Given the difficulty of differentiating true progression from pseudoprogression, clinical decline alone, in the absence of radiographic or histologic confirmation of progression, will not be sufficient for definition of progressive disease in the first weeks after completion of concurrent chemoradiotherapy\r\n* For patients with WHO grade III or IV glioma and progressive disease >= weeks after completion of chemoradiotherapy, progression can be defined by the following set of criteria:\r\n** New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids\r\n** Increase by >= % in the sum of the products of perpendicular diameters between the first post-radiotherapy scan, or a subsequent scan with smaller tumor size, and the scan at weeks or later on stable or increasing doses of corticosteroids\r\n** For patients receiving antiangiogenic therapy, significant increase in T/fluid attenuated inversion recovery (FLAIR) non-enhancing lesion may also be considered progressive disease; the increased T/FLAIR must have occurred with the patient on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy and not be a result of comorbid events (e.g., effects of radiation therapy, demyelination, ischemic injury, infection, seizures, postoperative changes, or other treatment effects)\r\n** Note: Clinical deterioration alone is not attributable to concurrent medication or comorbid conditions is sufficient to declare progression on current treatment but not for entry onto a clinical trial for recurrence\r\n* For patients with WHO grade II glioma progression is defined by any one of the following:\r\n** Development of new lesions or increase of enhancement (radiological evidence of malignant transformation)\r\n** A % increase of the T or FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not attributable to radiation effect or to comorbid events
All subjects must have documented disease progression during or after their last antimyeloma therapy
Documented disease refractory to at least one PD/PD-L inhibitor, defined as disease progression following at least infusions of the same drug; radiographic disease progression will be documented by the institutional radiologist based on any radiographic evidence (magnetic resonance imaging [MRI], computed tomography [CT], positron emission tomography [PET], or other modalities, etc.) of disease progression on two separate radiographic scans assessment obtained at least weeks apart; this minimum -week interval is required to define PD- inhibitor resistance based on imaging; alternatively, clinical disease progression may be documented on examination by the treating investigator
Disease progression following radiation and TMZ
For metastatic disease to lung, primary tumor needs to be controlled (no evidence of progression on imaging for at least months)
Patients who are initially rendered NED or have MRD following standard therapy but exhibit disease progression prior to initiation of vaccination
Patients must have progression after prior treatment with Enza at any point in the disease course (pre- or post-chemotherapy)
A single dose of a platinum doublet discontinued due to intolerability without evidence of disease progression is permitted
Participants must have shown unequivocal evidence of tumor progression.
Disease progression during or after the last treatment regimen and within months before study entry.
Patients must have completed cycles of R-CHOP with no evidence of disease progression
Registration within days of evidence of disease progression
Disease progression within months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
Progression of systemic disease at Screening
Phase II only: \r\n* Arm : disease progression after at least one cycle of prior treatment with cisplatin or carboplatin for incurable disease; prior treatment with cetuximab for incurable disease is not permitted\r\n* Arms and : disease progression after at least one cycle of treatment with cetuximab for incurable disease
Phase : Subjects who have disease progression after treatment with available therapies.
REGISTRATION # - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have undergone restaging tests according to the study calendar and determined to have no evidence of disease progression
First recurrence after concurrent or adjuvant chemoradiotherapy. Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria . A minimum of weeks must have elapsed from the completion of radiotherapy to study entry to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling.
Radiographic demonstration of disease progression by MRI following prior therapy.
All subjects must have histologic evidence of G MG (including glioblastoma and gliosarcoma) and radiographic evidence of recurrence or disease progression (defined as either a greater than % increase in the largest bidimensional product of enhancement, a new enhancing lesion, or significant increase in T FLAIR).
Progression: patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field are not eligible; patients deemed to have pseudoprogression are eligible
Disease progression > year after completing adjuvant therapy for Stage I-IIIA disease and no systemic therapy for the recurrent disease
Progression of disease after last therapy demonstrated by RANO criteria
Patients who have disease progression prior to completion of intended frontline therapy, including patients demonstrating disease progression after interval cytoreduction
Have evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) . criteria within months prior to study enrollment; if the patient was receiving a prior line of systemic therapy, he/she should have evidence of disease progression on that line of treatment prior to enrollment
Experienced an investigator-determined confirmed cutaneous or radiographic disease progression after stopping their initial treatment with MK-
Relapsed or refractory disease. Relapse is defined as progression of disease after an initial response to previous treatment, more than days after cessation of treatment. Refractory disease is defined as less than (<) percent (%) reduction in M-protein or progression of disease during treatment or within days after cessation of treatment
Patients must have documented disease progression while on Arm of this protocol; the follow-up tumor assessment form documenting disease progression must be submitted to Southwestern Oncology Group (SWOG) prior to Step Crossover Registration
Subjects with more than events of disease progression after the development of metastatic breast cancer.
Subjects must have completed or had disease progression on at least one prior line of disease-appropriate therapy or not be candidates for therapy of proven efficacy for their disease
Participants must have a mandatory biopsy at the time of disease progression according to RECIST . prior to crossing over. If not clinically feasible, discussion with Sponsor is required
Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within months prior to study enrollment; note: this assessment will be performed by the treating investigator; evidence of progression by RECIST criteria is not required
Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI. Additional other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
Patients must have central lab confirmation of tumour TM status from a biopsy taken after disease progression on the most recent treatment regimen. Only patients with TM+ will be included in the study
Evidence of tumor progression by MRI scan following radiation therapy or following the most recent anti-tumor therapy; note: patients who have had surgical treatment at recurrence are eligible if they had a resection with measurable residual disease on postoperative imaging or if there is imaging evidence of disease progression as compared to the first postoperative scan
The participant received combination chemotherapy prior to disease progression.
Patients are eligible upon progression after definitive local treatment (usually concurrent chemoradiation) if they are not candidates for salvage surgery or re-irradiation; patients are also eligible after progression on first line chemotherapy for recurrent disease
Disease progression within days of discontinuation from most recent therapy
HER-/neu status known and participants with HER/neu positive tumors show documentation of disease progression on treatment containing trastuzumab
Disease progression following therapy with erlotinib, afatinib, or gefitinib
Have rapidly progressing disease, as judged by the investigator (e.g., rapid progression through prior treatment[s])
Documented radiological disease progression during the most recent treatment regimen for metastatic disease
Patients must be three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression
Disease progression at study entry
Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within months prior to study enrollment; note: this assessment will be performed by the treating investigator; evidence of progression by RECIST criteria is not required
Documented disease progression after a platinum based chemotherapy in patients for whom administration of taxanes and anthracyclines is not planned. Progression must fulfill one of the following criteria:
Disease progression on or within days of completion of the last therapy
Subject has disease progression by at least one of the following:
Soft tissue disease progression as defined by RECIST .
Patients must have evidence of radiographic progression as defined below:\r\n* Stratum : defined as >= % increase in the product of the greatest perpendicular diameters of the tumor as a whole (solid and cystic component) AND >= . cm increase in each of at least two dimensions of the tumor as a whole OR any new or worsening neurologic/vision deficit in conjunction with a lesser change in the solid or cystic component\r\n* Stratum : \r\n** For patients more than months following radiation therapy (RT) (including radiosurgery or P), progression is defined as a >= % increase in the product of the greatest perpendicular diameters of the solid component AND >= . cm increase in each of at least two dimensions of the solid component\r\n** For patients more than months following RT (including radiosurgery or P), progression is defined as >= % increase in each of the product of the greatest perpendicular diameters of the solid tumor AND >= . cm increase in each of at least two dimensions of the solid tumor; patients demonstrating predominantly cystic progression more than months after RT must show a continued increase in the cystic component on two serial MRI scans performed at least weeks apart OR re-accumulation of the cyst following one or more cyst aspirations; patients with progressive neurologic signs and/or symptoms associated with isolated cyst formation or progression are eligible if the neurologic signs and/or symptoms do not improve within weeks of cyst aspiration
For the dose-finding phase, patients may have stable disease OR progression of disease on the most recent treatment; for the expansion phase, patients must also have stable disease OR progression of disease on the most recent treatment; progression of disease is defined as new or worsening disease on objective imaging; progression or disease includes recurrence diagnosed while on adjuvant letrozole or exemestane
Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment.
Radiological evidence for progressive disease (measurable or non-measurable) within months prior to registration; patients who have received anti-tumor therapy during the past months (including octreotide analogs) must have had radiological documentation of progression of disease while on or after receiving therapy
Concurrent use of somatostatin analogs (SSTa) is allowed, provided that the patient is on a stable dose for at least two months and progressive disease on somatostatin analog has been documented; progression on octreotide is required for patients with tumors arising in the midgut
Anatomic imaging (CT or MRI) of all sites of disease along with chest CT at baseline and restaging for all patients will be done to allow for assessment of RECIST progression. RECIST progression will determine progressive disease regardless of other imaging.
Patient must have documented disease progression, and date of last documented disease progression must be within months from date of randomization
Concurrent somatostatin analogues are allowed provided that the patient \r\n* Has been on a stable dose (+/- mg) for weeks and \r\n* Has documented disease progression on that dose
Relapse or progression after at least systemic therapy
Less than years between last therapy and progression (e.g. most recent progression free interval < years)
Minimum of months of maintenance therapy prior to disease progression
Must have documented disease progression during or after their last anti-myeloma therapy.
Patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their current cancer prior to therapy that, in the investigators opinion, would preclude their inclusion
Patients who have evidence of disease progression before day after ASCT
Progression following prior ofatumumab-based therapy
Gynecologic Cancer Intergroup (GCIG)-defined CA progression and absence of disease upon imaging or small-volume asymptomatic disease upon imaging and who have progressed following one, two or three lines of chemotherapy for recurrent disease
Permanent discontinuation of GSK in the parent study due to toxicity or disease progression.
Concurrent somatostatin analogues are allowed provided that patients ) have been on stable doses x weeks and ) have documented disease progression on that dose
Participants must have met all criteria to be enrolled on the main protocol for receipt of neratinib; at the time of enrollment on the extension phase for cohorts and , patients must have experienced progression of non-CNS disease by RECIST . criteria
Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
Clinical progression of symptoms with any radiographic progression on MRI within days prior to registration (any progression in size or enhancement on MRI along with worsening symptoms, will be defined as progression prior to enrollment); radiographic progression is defined as any increase in tumor size (in axial or sagittal images) or progressive contrast enhancement and abnormal T/FLAIR signal by MRI
Disease progression prior to randomization
Permanent discontinuation of GSK in the parent study due to toxicity or disease progression.
No evidence of relapse or progression of underlying disease (molecular evidence of relapse/progression or mixed chimerism is permitted)
Biochemical or radiologic documentation of disease progression within the last months prior to enrollment
Permanent discontinuation of GSK in the parent study due to toxicity or disease progression
If the subject received immunotherapy, the documented radiographic disease progression is required
COHORT AND ACINIC CELL CARCINOMA PATIENTS IN COHORT ONLY: Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within months prior to study enrollment; Note: this assessment will be performed by the treating investigator; evidence of progression by RECIST criteria is not required
Patients who have ASM with eosinophilia and known positivity for the FIPL-PDGFR? fusion unless they have demonstrated relapse or disease progression on prior imatinib therapy
Cutaneous T-cell lymphomas (mycosis fungoides, Sezary syndrome)\r\n* >= Stage III\r\n* Disease progression >= prior regimens, including at least one systemic therapy
Evidence of relapse or progression of disease after transplantation
Having documented disease progression on enzalutamide defined by or more of the following criteria:
Radiographic progression in soft tissue or bone by modified RECIST . for subjects with measurable disease; or
Predicted not to have significant clinical progression at months
Completion of at least cycle of treatment with ibrutinib and confirmed evidence of disease progression or refractoriness to treatment or
Radiologic documentation of disease progression
measurable disease at screening and documented progression within the past weeks
No response or disease progression ? months from start of last previous therapy
Patients must have documented disease progression after receiving at least one prior therapeutic regimen (e.g. pralatrexate, romidepsin, bexarotene, vorinostat)
Must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous months).
Disease progression following radiation & TMZ
Subjects with a history of prior radiotherapy are eligible if they meet the following parameters: Prior to study treatment administration, must be ? days post-therapy and have recovered from all toxicities; must have evidence of measurable disease outside the radiation fields or radiologically confirmed progression of disease; must not have had > % of their functional bone marrow irradiated. Must have radiologically measureable disease, a life expectancy > weeks, and adequate organ function.
Progression was documented,
Documented disease progression during or following most first line therapy for advanced disease
Evidence of disease progression on neoadjuvant chemo T
Disease progression despite standard therapies
Radiographic progression, defined by RECIST v.., after the last cancer treatment and within weeks prior to enrollment, compared with scans within year of enrollment.
Subjects must have received one or more prior systemic therapies for this disease, with disease progression or intolerable toxicity precluding further therapy with prior regimen(s)
Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
Has evidence of disease progression under Protocol -.
Disease progression either clinically or radiographically after - previous regimens.
Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease
Patients must have experienced disease recurrence or progression during or after prior treatment with one or more prior standard systemic therapies;
Radiographic progression by RANO Working Group Criteria will be confirmed by Imaging Endpoints, a central imaging vendor.
Patients may be on specific targeted therapy (erlotinib or crizotinib) as long as they have not had disease progression
Histologically or cytologically confirmed high-grade metastatic sarcoma that has been stable on - cycles of one chemotherapeutic regimen (cytotoxic or biologic) although a change in chemotherapy is allowed if it is a result of toxicity/tolerability rather than progression; a patient must not have evidence of progression at any time while on chemotherapy in order to be eligible for this trial
experienced no progression of disease per the irRC
Patients must have evidence of progression of disease during or after last treatment
Documented evidence of disease progression during month period prior to the time of enrollment
Participants who developed disease progression/ requiring other anti-tumor therapy while in the parent protocol
Disease progression in the past months
Prior radioactive iodine must have been completed at least months prior to registration, or there must be documented disease progression since such therapy if it was within months; sites that have received EBRT must have disease progression post-EBRT to be used as sites of measurable disease
Progressive disease defined as one or more of the following three criteria (Note: subjects who received an antiandrogen must demonstrate disease progression following discontinuation of antiandrogen):
Evidence of tumor progression by MRI or computed tomography (CT) scan following radiation therapy or following the most recent anti-tumor therapy; note: patients who have had surgical treatment at recurrence are eligible if they had a resection with measurable or non-measurable residual disease on postoperative imaging or if there is imaging evidence of disease progression as compared to the first postoperative scan
There is progression of disease documented by RECIST .
Patients must show evidence of objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) on scans within the month period immediately preceding enrollment; both scans used to determine disease progression should have been obtained within this -month period
Patients with newly diagnosed, unresectable, metastatic, and measurable ASPS who show clinical evidence of disease progression (including history and increasing physical symptoms) will also be eligible; on-study documentation will include a physicians rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain)
Phase : Subjects who have disease progression after treatment with available therapies.
Must have metastatic, progressive, castrate-resistant prostate cancer (CRPC) with radiographic evidence of disease that has continued to progress radiographically or biochemically (rising prostate-specific antigen [PSA] levels on successive measurements) despite adequate androgen-deprivation therapy; if patients had been on flutamide, disease progression is documented weeks or more after withdrawal; for patients on bicalutamide or nilutamide disease progression is documented or more weeks after withdrawal; flutamide, nilutamide and bicalutamide disease progression requirements only apply to patients who have been on these drugs for at least the prior months
Participants may not be receiving any other study agents or other types of cancer therapy while on this protocol except for disease progression
Subjects must have documented disease progression prior to enrolling into the study
Part II: Postmenopausal women with locally ABC or MBC whose disease has progressed during or after treatment with an AI. Participants who discontinued the AI for toxicity rather than completion of regimen or for disease progression are not eligible
Randomization within weeks of progression of disease
Radiographic evidence of disease progression by RECIST criteria on or after the last anti-cancer therapy within the months prior to randomization.
Evidence of disease progression, as determined by the investigator
Progression during the first months of initiating treatment
Hormone-refractory metastatic breast cancer defined as disease progression within months from starting most recent hormonal therapy
The participant has experienced radiographic, biochemical, and/or scintigraphic disease progression while on a regimen that includes octreotide
Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment.
Progression of solid tumors/lymphomas: Patients demonstrating clear tumor progression weeks after receiving DLI will not be eligible to receive additional DLI
Patients with documented disease progression on salvage chemotherapy
Patients must have refractory disease, disease relapse or progression after at least two prior systemic chemotherapy or immunotherapy regimens\r\n* Note: Exceptions may be made if a patient is deemed unfit for first-line salvage therapy by the treating physician; such cases should be clearly documented
progression of disease at the time of Enrollment
And for Treatment Period only: ) Patients participating in Treatment Period must have had disease progression after receiving at least weeks of progestin therapy or ) Patients must be determined as PrR negative status at Screening.
Dose Confirmation Cohort A (DC-A) only: Currently receiving enzalutamide as most recent systemic therapy for mCRPC and have experienced PSA progression by PCWG criteria in the absence of radiographic and/or clinical progression. Patients may or may not have experienced prior progression on abiraterone.
Survival - years after most recent HCT with no evidence of relapse, disease progression, or secondary cancer on last follow-up
Evidence of disease progression that would necessitate a treatment in the next weeks
Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.
Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression
Has radiological documentation of disease progression while receiving continuous treatment with erlotinib, gefitinib, afatinib, or osimertinib
Well differentiated, low, intermediate, or high-grade, gastrointestinal mid-gut (arising from the lower jejunum, ileum, appendix, cecum, and proximal colon) NET with documented disease progression within months prior to start of study treatment and evidence of radiographic disease progression based on scans performed not more than months apart. Patients may have received or more prior lines of anticancer therapy, such as somatostatin analogues, targeted agents, or liver-directed intra-arterial therapy, but are NOT eligible if they have received prior systemic cytotoxic chemotherapy or peptide receptor radionuclide therapy (PRRT).
If receiving an antiandrogen as part of first-line hormonal therapy, must have shown progression of disease off the antiandrogen prior to enrollment
Soft tissue progression
Criteria , Participants had disease progression during or after one or more prior standard of care systemic anti-cancer therapy (eg chemotherapy, targeted therapy) for metastatic disease
Documented disease progression during or immediately after last therapy according to any of the aforementioned criteria.
Disease progression within months prior to study enrollment.
They show evidence of disease progression during or within months of the end\n of adjuvant ET.
Time of disease progression.
Participants must show evidence of disease progression within months (an additional month will be allowed to accommodate actual dates of performance of screening scans, ie, within ? months) prior to signing informed consent, according to RECIST . assessed and confirmed by central radiographic review of CT and/or MRI scans.