[c09aa8]: / clusters / 9knumclustersv2 / clust_2192.txt

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Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and bisphosphonates); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least days prior to registration and any therapy-induced toxicity must have recovered to =< grade , except alopecia and =< grade neuropathy which are allowed; any planned radiation therapy must be completed before enrollment onto S
Patients must not be planning to require any additional form of systemic anti-tumor therapy while on protocol treatment
Patients must be registered within days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of months at the time of registration (Note: sequencing of ablative therapy [surgery or SBRT] relative to systemic therapy, for patients randomized to Arm , is at the discretion of the treating physician)
Persistence of clinically relevant therapy related toxicity from previous anti-cancer therapy
Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within days prior to Cycle Day-.
Participants who have had prior anti-EGF or anti-HER therapy or cancer-directed chemotherapy
Escalation Phase: Subjects may be enrolled with ? lines of prior systemic anti-cancer therapy (but no immunotherapy). Subjects who have had no prior systemic anti-cancer therapy (i.e. first-line therapy) or declined first-line treatment are permitted in the Escalation Phase.
For Cohort C only: any prior anti-cancer therapy for advanced melanoma
Patients with prior hepatitis B vaccine are permitted (defined as HBsAg-, Anti-HBs+, Anti-HBc-).
Recent systemic anti-cancer therapy
No prior other anti-cancer therapy, including ACT, for days prior to study administration of atezolizumab
Prior cancer therapy or anti-cancer vaccine within weeks of initial study treatment.
Concurrent or planned systemic chemotherapy, radiotherapy, new hormonal or anti- HER directed therapy directed at management of breast cancer (existing anti-HER therapy can be continued as recently recommended in the National Consensus Guidelines)
Anti-platelet therapy, except low-dose aspirin for cardioprotection
Ongoing or planned systemic anti-cancer therapy or radiation therapy
Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within days prior to ABBV- dosing. Saw palmetto is considered anti-cancer herbal remedy. Participant with CRPC who has received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within a period of days prior to Study Day . Participant with AML has received anti-cancer therapy within a period of days or half-lives (whichever is longer; except for immunotherapy where a period of days will be acceptable) prior to Study Day . Except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis for AML subjects.
Prior standard or investigational anti-cancer therapy, as specified below:
Concurrent administration of any other anti-cancer therapy (except male participants with prostate cancer receiving androgen blockade: Bisphosphonates and denosumab are allowed; Most recent anti-cancer therapy </= days and have not recovered from the side effects, excluding alopecia; Radiaiton therapy within </= days
concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates
At least weeks must have passed since any prior anti-tumor therapies including chemotherapy, radiation therapy or any other anti-cancer treatments
Concurrent use of another anti-cancer drug including an investigational anti-cancer agent
Prior anti-angiogenic therapy, including thalidomide and oral cyclophosphamide, is permitted
Patients requiring anti-coagulant therapy
Has had any systemic anti-cancer therapy (includes anti-VEGF therapy or any systemic investigational anti-cancer agent)
Naive to prior systemic anti-cancer therapy for melanoma
Subjects must not have received any prior standard or investigational anti-tumor therapy other than surgery and must not intend to receive any standard or investigational anti-tumor therapy other than the study regimen
Prior use of any standard or investigational anti-tumor therapy other than surgery
Anticancer chemotherapy during the study or within weeks of study enrollment; subjects must have recovered from the toxic effects of the previous anti-cancer chemotherapy (with the exception of alopecia); anti-cancer therapy is defined as any\r\nagent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints
Concurrent administration of other anti-cancer therapy within days of starting protocol therapy and during the course of this study
Patients may not be receiving any other anti-cancer therapy.
Patient can have had prior treatment for HCC including prior surgery, radiation therapy, local-regional therapy (abalation or arterial directed therapies), and systemic therapy including sorafenib or chemotherapy (but not anti-PD- or anti-CTLA- therapy)
Patients, who have previously received in vivo anti-GD monoclonal antibodies for biologic therapy or for tumor imaging, are eligible unless they have had an anaphylactic reaction attributed to anti-GD therapy
History of anaphylaxis attributed to prior anti-GD therapy
Use of parenteral (IV or intramuscular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within days prior to planned start of therapy
Concomitant use of any anti-cancer therapy or radiation therapy
FOR ALL PHASES (Ib AND II): Concurrent therapy with any other non-protocol anti-cancer therapy
Anti-cancer therapy, including an investigational agent, less than days prior to the first dose of nivolumab
Has had a prior systemic anti-cancer treatment within the last weeks
Immunosuppressive therapies within weeks of leukapheresis and JCAR administration (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolyate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti IL, or anti-ILR)
One prior anti-cancer therapy that did not work
More than one line of anti-cancer therapy or no treatment at all
Evidence of active infection that requires anti-bacterial, anti-viral, or anti-fungal therapy =< days prior to initiation of study drug therapy
Concurrent treatment with other anti-cancer therapy is not permitted
Concurrent administration of any other anti-tumor therapy
PART GROUP EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapy
PART GROUP A EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapy
PART GROUP EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapy
Prior anti-estrogen therapy within the last years
Concomitant use of any anti-cancer therapy or immune modifier.
Have received NO anti-cancer therapy within days prior to receiving study drug
Is receiving concurrent anti-cancer therapy for metastatic disease
Any anti-cancer therapy within the past days of the first day of treatment
Concurrent treatment with other investigational drugs or anti-cancer therapy.
Concomitant use of any anti-cancer therapy or radiation therapy
Other concomitant anti-cancer therapy except corticosteroids
Other anti-cancer or investigational therapy while patients are on study therapy
Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
Prior treatment with anti-lymphocyte globulin or anti-thymocyte globulin
Treatment with other investigational drugs or anti-cancer therapy within days prior to enrolment.
Oral treatment with anti-infective therapy that has been administered less than one week prior to first dose in this trial.
Received prior systemic anti-cancer therapy for NSCLC
Concurrent anti-cancer therapy
Has received systemic anti-cancer therapy within the weeks prior to starting the trial.
Have received last dose of first-line systemic anti-cancer therapy or date of most recent local regional therapy > days prior to day
Patient is concurrently using other anti-cancer therapy. All anti-cancer therapy must be discontinued prior to day one of study treatment.
ARM A: Systemic anti-cancer therapy =< weeks prior to registration
ARM B: Systemic anti-cancer therapy =< weeks prior to registration
Use of other anti-cancer therapies within five half-lives from the previous dose of the prior anti-cancer therapy preceding enrollment and during the study
Prior investigational anti-cancer therapy within weeks prior to day
Anti-angiogenic therapy within the last month
GVHD therapies: Any systemic drug used for GVHD must be stopped > weeks prior to CTL infusion to confirm that GVHD recurrence is not observed (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD (rituximab), anti-tumor necrosis factor [anti-TNF], anti-interleukin [anti-IL] or anti-interleukin receptor [anti-ILR], systemic steroids)
Concurrent administration of any other anti-cancer therapy within days of starting protocol therapy and during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed)
GVHD therapies: Any drug used for GVHD must be stopped > weeks prior to CTL infusion (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolyate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD (rituximab), anti-TNF, anti-IL or anti-ILR)
Anti-tumor therapy within days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted
Anti-androgen receptor antagonist therapy must be bicalutamide. Subjects already started on other anti-androgens must be willing to switch over to bicalutamide.
Did not receive any anti-cancer treatment since the last dose of MK-
No planned concomitant, non-protocol directed anti-cancer therapy
Any anti-cancer therapy within weeks of study drug
Standard treatment interrupted, except if anti-HER therapy
No prior systemic anti-cancer therapy for advanced ER+ disease
Evidence of active infection that requires anti-bacterial, anti-viral, or anti-fungal therapy =< days prior to initiation of study drug therapy
No prior systemic anti-cancer therapy for advanced ER+ disease.
However, subjects who are HER- positive and responsive to anti-HER- therapy (e.g. Herceptin), are encouraged to remain on anti-HER- therapy and not enroll in this trial.
Concomitant use of any anti-cancer therapy or radiation therapy, or any other investigational agent
Prior anti-HER targeting therapy
Received systemic anti-cancer therapy within days of Week , Day of study treatment.
Recent cancer-directed therapies: Radiotherapy (RT) within weeks, chemotherapy or other systemic anti-cancer therapy within weeks, or prior anti-angiogenic treatment (e.g., bevacizumab) within weeks prior to starting treatment
More than previous systemic anti-cancer therapy line
Patients receiving anti-cancer therapy within days before MSC treatment
Concurrent anti-platelet therapy
Alternative anti-cancer treatment
Anti-cancer therapy =< days prior to randomization
Patients who are currently taking any anti-cancer directed therapy; steroids are not considered anti-cancer therapy
For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)
No prior systemic anti-cancer therapy for advanced disease.
Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer Note:
GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-? [TNF?], anti-interleukin- [IL-], or anti-interleukin- receptor [IL R]) within weeks prior to leukapheresis
Receiving or have received systemic anti-cancer therapy within days prior to starting study treatment
Concurrent administration of any other anti-tumor therapy
Uncontrolled cancer requiring the institution of new anti-cancer therapy during the study period
Any systemic anti-cancer treatment out of allowed timelines
Prior anti-tumor therapy within weeks
Ongoing or planned systemic anti-cancer therapy or radiation therapy
Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast cancer
Specific anti-cancer therapy within weeks of study start
Prior therapy with anti-angiogenic agents is permitted
Other anti-cancer therapy up to days prior to enrollment, with the exception of hydroxyurea, which can be given up to days prior to enrollment.
Has received systemic anti-cancer therapy within the days prior to randomization
Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within weeks prior to the first dose of the investigational drug.
Concurrent therapy with any other non-protocol anti-cancer therapy
Being treated with anti-TNF therapies or has been treated with an anti-TNF therapy within half-lives of randomization.
Prior EGFR-targeted regimen, anti-HER, anti-HER, or anti-HER therapy
Prior anti-androgens are permitted but not required ( week washout from anti-androgens)
Currently receiving any anti-tumor treatments, or less than days prior to enrollment since ending anti-tumor treatment
Has received other anti-cancer therapy within the following specified intervals prior to Day :
Concurrent treatment with other anti-cancer therapy
Prior anti-estrogen therapy.
Subjects with breast cancer must have been treated with at least two FDA-approved anti-HER directed therapies (more than two is also permissible), and subjects with gastric and gastroesophageal junction cancers must have been treated with at least one FDA-approved anti-HER directed therapy (more than one is also permissible); and all subjects must have refractory or relapsed/progressive disease during or following their last prior anti-HER directed therapy.
Subjects enrolling in the study who have non-breast, non-gastric, non-gastroesophageal junction cancers do not require any prior treatment with anti-HER therapy if there is no FDA-approved anti-HER agent for their specific cancer type, but they must have refractory or relapsed/progressive disease during or following their last prior anti-cancer therapy.
Anti-tumor therapy within days of study day
Concurrent anti-cancer treatment, except anti-hormonal therapy for subjects with hormone receptor positive breast cancer
Prior treatment with anti-HER therapy, except trastuzumab or lapatinib
Therapeutic anti-coagulative or long term anti-platelet treatment.
Anti-tumor therapy within days of study Day
Concurrent therapy with any other non-protocol anti-cancer therapy
For Arms A and C: Treatment with any FGFR inhibitor. For Arm B: Treatment with any anti-cancer therapy (for biological anti-cancer therapies see criteria below) during the preceding weeks or within half-lives of the therapy, whichever is longer.
Prior anti-cancer therapy
Anti-cancer treatment days prior to study Day , except in Arm B expanded cohort temozolomide therapy is allowed
Anti-tumor therapy
Previously treated with an anti-Dickkopf- (anti-DKK-) or antibody therapy, or have had a significant allergy to a known pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient
Patients on concurrent anti-cancer therapy other than that allowed in the study
Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungals, and anti-viral agents)
Evidence of active infection, requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy < days prior to administration of study medication
Participants requiring anti-hyperglycemic therapy
Previously received E anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in Phase Ib only);
Anti-tumor therapy within days of study day including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
Less than (<) weeks since the last anti-tumor therapy prior to Day of study treatment
Concurrent therapy with any other non-protocol anti-cancer therapy
Patients on concurrent anti cancer therapy other than that allowed in the study.
No prior anti-cancer treatment
No prior treatment with systemic anti-cancer therapy for SCCHN unless protocol-defined conditions are met.
Anti-cancer therapy within days prior to starting on therapy
No other investigational or standard anti-tumor therapy allowed
Ongoing anticoagulant, statin and/or anti-platelet therapy
Patients who are able to comply with the anti-emetic therapy
Must have received systemic therapy for their breast cancer (anti-estrogen and/or chemotherapy)\r\n* Chemotherapy must be complete prior to entry\r\n* Anti-estrogen therapy may be ongoing
Concurrent anti-cancer therapy
Patients must not be receiving anti-myeloma therapy (including maintenance therapy)
Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasites, anti-virals
Patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations
Patients must be anti-angiogenic therapy naive
Participants who have already received anti-VEGF or investigational anti-angiogenic therapy for glioblastoma
Had at least prior anti-MM regimen and no more than prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as anti-MM regimen.
Anti-androgenic therapy within days prior to enrollment
Persistent acute toxicities from prior anti-cancer therapy.