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 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =< grade 2 neuropathy which are allowed; any planned radiation therapy must be completed before enrollment onto S1609
Patients must not be planning treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type
Patients must not be planning to require any additional form of systemic anti-tumor therapy while on protocol treatment
Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, 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 12 months at the time of registration (Note: sequencing of ablative therapy [surgery or SBRT] relative to systemic therapy, for patients randomized to Arm 2, 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 14 days prior to Cycle 1 Day-2.
Participants who have had prior anti-EGF or anti-HER2 therapy or cancer-directed chemotherapy
3. Receipt of any investigational anti-cancer therapy within 4 weeks prior to first dose of TAB001;
Escalation Phase: Subjects may be enrolled with ? 2 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 28 days prior to study administration of atezolizumab
Prior cancer therapy or anti-cancer vaccine within 4 weeks of initial study treatment.
Concurrent or planned systemic chemotherapy, radiotherapy, new hormonal or anti- HER2 directed therapy directed at management of breast cancer (existing anti-HER2 therapy can be continued as recently recommended in the National Consensus Guidelines)
At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
Last anti-cancer treatment within 2 weeks prior to study entry
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start
Ongoing or planned systemic anti-cancer therapy or radiation therapy
Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to ABBV-744 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 21 days prior to Study Day 1. Participant with AML has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to Study Day 1. 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 </=28 days and have not recovered from the side effects, excluding alopecia; Radiaiton therapy within </=14 days
Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.
At least 3 weeks must have passed since any prior anti-tumor therapies including chemotherapy, radiation therapy or any other anti-cancer treatments
Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible
Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug
Concurrent use of another anti-cancer drug including an investigational anti-cancer agent
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study enrollment
Patient shouldn’t have received any anti-cancer therapy for glioblastoma in past
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
Monoclonal antibody based anti-cancer therapy within 28 days prior to study entry or small-molecule based anti-cancer therapy (targeted therapy or chemotherapy) within 14 days prior to study entry.
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 4 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 14 days of starting protocol therapy and during the course of this study
Patients may not be receiving the concomitant administration of any systemic therapy, biologic therapy, or other agents with anti-tumor activity against prostate cancer while the patients are on study.
Current or prior anti-cancer treatment prior to the first dose of pembrolizumab as defined below:\r\n* Chemotherapy, targeted small molecule therapy, or other anti-cancer treatment not otherwise specified below within 2 weeks\r\n* Radiation therapy within 2 weeks\r\n* Anti-cancer monoclonal antibody (mAb) treatment within 4 weeks\r\n* Use of an investigational agent (e.g., biologic, drug, or other) within 4 weeks\r\n* Allogeneic stem cell transplant within 100 days\r\n* Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent at any time
Patients may not be receiving any other anti-cancer therapy.
Patients, who have previously received in vivo anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging, are eligible unless they have had an anaphylactic reaction attributed to anti-GD2 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
Has had a prior systemic anti-cancer treatment within the last 8 weeks
Patients with a diagnosis of CD22-positive acute lymphoblastic leukemia (ALL) based on local immunophenotyping and histopathology who have:\r\n* Refractory disease, defined as disease progression or no response while receiving their most recent prior anti-cancer therapy,\r\n* Relapsed disease, defined as response to their most recent prior anti-cancer therapy with subsequent relapse
Immunosuppressive therapies within 4 weeks of leukapheresis and JCAR017 administration (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolyate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti IL6, or anti-IL6R)
One prior anti-cancer therapy that did not work
More than one line of anti-cancer therapy or no treatment at all
Any prior systemic anti-cancer immunotherapy treatment
Prior anti-tumor therapy within 3 weeks of cycle 1 day 1 (anti-tumor therapy defined as, but is not limited to, anti-cancer agents (cytotoxic chemotherapy, immunotherapy, and biologic therapy), radiotherapy, and investigational agents), the “wash-out period”
Evidence of active infection that requires anti-bacterial, anti-viral, or anti-fungal therapy =< 7 days prior to initiation of study drug therapy
Concurrent treatment with other anti-cancer therapy is not permitted
Receipt of any anti-cancer therapy within 14 days of starting BP1001, with the exception of hydroxyurea or anagrelide, or TKI (within 2 days)
PART 2 GROUP 1 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 2 GROUP 2A 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 2 GROUP 3 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
Is currently receiving active treatment with anti-cancer systemic chemotherapy, investigational agent, or biological therapy
Subject has received any of the following:\r\n* Chemotherapy, biological therapy, or surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to on-study date\r\n* Radiation therapy, within 10 weeks prior to entering the study or those who have not recovered from adverse events due to radiation administered more than 10 weeks prior to on-study date\r\n* Prior therapy with bevacizumab\r\n* Prior therapy with an anti-programed cell death 1 (PD-1), anti-programed cell death 1-ligand (PD-L)1, anti-PD-L2, anti-cluster of differentiation (CD)137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody\r\n* Prior treatment with an HDAC inhibitor, with the exception of prior or current treatment with valproate\r\n* Any investigational agents or have had any investigational agent within the 30 days prior to on-study date\r\n* A live vaccine within 30 days prior to on-study date\r\n* Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to on-study date
Excluded therapies and medications for cancer\r\n* Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study enrollment; subjects must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy (with the exception of alopecia); anti-cancer therapy is defined as any agent 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; however, subjects with prostate cancer who are receiving depot luteinizing hormone-releasing hormone (LHRH) agonist therapy may continue on this treatment\r\n* Hormonal therapy during the study or within 2 weeks of first study enrollment\r\n* Radiotherapy to target lesions during study or within 4 weeks of first study treatment\r\n* An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation\r\n* Bone marrow transplant or stem cell rescue\r\n* Bisphosphonate therapy during the first 2 cycles of treatment\r\n* Granulocyte colony stimulating factor (G-CSF) and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the principal investigator; however they may not be substituted for a required dose reduction; erythropoietins are not permitted\r\n* Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
Prior anti-estrogen therapy within the last 5 years
Have received NO anti-cancer therapy within 28 days prior to receiving study drug
Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational
Has been treated with anti-cancer therapy or thoracic radiation therapy within 14 days
Is receiving concurrent anti-cancer therapy for metastatic disease
Any anti-cancer therapy within the past 21 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
For purposes of this protocol, anti-tumor treatment may be defined as, but is not limited to, anti-cancer agents (cytotoxic chemotherapy, immunotherapy, biologic therapy), radiotherapy, and investigational agents; an investigational agent is any drug or therapy not currently approved for use in humans\r\n* Anti-cancer agents: anti-cancer agents are not permitted within 21 days prior to start of POPI; there are no limitations on the type or number of prior regimens; hormonal therapy and trastuzumab are permitted during POPI\r\n* Radiation: prior treatment with breast irradiation is not allowed \r\n* Surgery: incident breast biopsies only permitted prior to POPI to confirm residual disease after NAC
Other concomitant anti-cancer therapy except corticosteroids
Other anti-cancer or investigational therapy while patients are on study therapy
Received the last anti-cancer therapy at least 28 days ago
Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
Treatment with other investigational drugs or anti-cancer therapy within 28 days prior to enrolment.
Any ongoing toxicity from prior anti-cancer treatment that, in the judgement of the investigator, may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 (NCI CTCAE version 4) or baseline prior to enrollment. Eligible patients must not require more than 10 mg/day prednisone (or equivalent dose).
Received prior systemic anti-cancer therapy for NSCLC
Concurrent anti-cancer therapy
Has received systemic anti-cancer therapy within the 3 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 >28 days prior to day 1
Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
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 =< 4 weeks prior to registration
ARM B: Systemic anti-cancer therapy =< 4 weeks prior to registration
Concomitant therapy with any anti-cancer agents, other investigational anti-cancer therapies, or immunosuppressive agents including but not limited to methotrexate, chloroquine, azathioprine, etc. within six months of study participation
Any anti-cancer therapy or investigational agents =< 4 weeks prior to registration
Concomitant therapy with any anti-cancer agents, other investigational anti-cancer therapies, or immunosuppressive agents; chronic use of systemic corticosteroids
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 4 weeks prior to day 1
GVHD therapies: Any systemic drug used for GVHD must be stopped > 4 weeks prior to CTL019 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-CD20 (rituximab), anti-tumor necrosis factor [anti-TNF], anti-interleukin 6 [anti-IL6] or anti-interleukin 6 receptor [anti-IL6R], systemic steroids)
Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
Concurrent administration of any other anti-cancer therapy within 14 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 > 4 weeks prior to CTL019 infusion (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolyate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20 (rituximab), anti-TNF, anti-IL6 or anti-IL6R)
Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted
Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started 1 month prior to enrollment on this study; in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists
No ongoing toxicity from prior anti-cancer treatment that may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 or baseline before administration of the study treatment.
No previous anti-cancer treatment
Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy (including monoclonal antibodies), or experimental anti-cancer therapy) within 28 days prior to beginning study therapy. Note: Ongoing castrating therapy with a GnRH agonist or antagonist is mandatory to assure a castrate level of serum testosterone <50 ng/dL, except in patients who have undergone an orchiectomy. Bisphosphonates or denosumab continuation is permissible (i.e., no change for 30 days prior to Cycle 1 Day 1). Patients who receive a dose of EC1169 under another Endocyte protocol do not need a washout period for EC1169
Any anti-cancer therapy within 3 weeks of study drug
No prior systemic anti-cancer therapy for advanced ER+ disease
Evidence of active infection that requires anti-bacterial, anti-viral, or anti-fungal therapy =< 7 days prior to initiation of study drug therapy
No prior systemic anti-cancer therapy for advanced ER+ disease.
However, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.
Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
Concomitant use of any anti-cancer therapy or radiation therapy, or any other investigational agent
Prior anti-HER2 targeting therapy
Received systemic anti-cancer therapy within 30 days of Week 0, Day 11 of study treatment.
Recent cancer-directed therapies: Radiotherapy (RT) within 4 weeks, chemotherapy or other systemic anti-cancer therapy within 4 weeks, or prior anti-angiogenic treatment (e.g., bevacizumab) within 6 weeks prior to starting treatment
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic or immunotherapy agents that can present with major delayed toxicity (eg, anti-CTLA-4), 4 weeks is indicated as washout period
More than 1 previous systemic anti-cancer therapy line
Patients receiving anti-cancer therapy within 21 days before MSC treatment
Patients who are receiving any other anti-cancer or investigational drug therapy are excluded
Alternative anti-cancer treatment
Anti-cancer therapy =< 14 days prior to randomization
Patients who are currently taking any anti-cancer directed therapy; steroids are not considered anti-cancer therapy
Participation in an investigational anti-cancer study within 3 weeks prior to initiation of 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-HER2 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:
Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:
Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
Other concomitant anti-cancer therapy agents excepts steroids
Uncontrolled cancer requiring the institution of new anti-cancer therapy during the study period
Patients who have received systemic anti-cancer therapy such as chemotherapy, immunotherapy and/or biologic therapy =< 4 weeks prior to study entry; concurrent anti-cancer therapy (chemotherapy, immunotherapy, biologic therapy) other than the ones specified in the protocol is not permitted during study participation; patients must have discontinued the above cancer therapies for 4 weeks prior to the first dose of study medication, as well as recovered from toxicity (to =< than grade 1, except for alopecia) induced by previous treatments; any investigational drugs should be discontinued 4 weeks prior to the first dose of study medication
Any systemic anti-cancer treatment out of allowed timelines
Other concomitant anti-cancer therapy agents except steroids
Prior anti-tumor therapy within 2 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 3 weeks of study start
Prior therapy with anti-angiogenic agents is permitted
Has received systemic anti-cancer therapy within the 14 days prior to randomization
Treatment with any immunomodulatory medication within 4 weeks of initiation of study therapy, except for anti-tumor therapy (e.g., anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4])
Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug.
Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized.
Use of any anti-cancer drug therapy within 14 days prior to Baseline (within 28 days for monoclonal antibodies [eg anti-CD38]).
Concurrent therapy with any other non-protocol anti-cancer therapy
Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
Prior anti-androgens are permitted but not required (2 week washout from anti-androgens)
Treatment with any approved anti-cancer therapy within 3 weeks prior to the first dose of study treatment
Has received other anti-cancer therapy within the following specified intervals prior to Day 1:
Concurrent treatment with other anti-cancer therapy
Anti-cancer therapy within 28 days prior to the first dose of study-drug treatment in Cycle 1
Prior anti-estrogen therapy.
Use of any approved anti-cancer therapy within 3 weeks prior to treatment
Subjects enrolling in the study who have non-breast, non-gastric, non-gastroesophageal junction cancers do not require any prior treatment with anti-HER2 therapy if there is no FDA-approved anti-HER2 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 14 days of study day 1
Concurrent anti-cancer treatment, except anti-hormonal therapy for subjects with hormone receptor positive breast cancer
Therapeutic anti-coagulative or long term anti-platelet treatment.
Anti-tumor therapy within 21 days of study Day 1
Patients receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started >= month prior to enrollment on this study; patients may be on low molecular weight heparin or direct factor Xa inhibitors
For Part 1, subjects may have had any number of prior systemic anti-cancer treatments, but may not have received more than 2 schedules of myeloablative chemotherapy. For Parts 2 and 3, more than two prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma are not permitted. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least 8 weeks prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3.)
Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe.
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 4 weeks or within 4 half-lives of the therapy, whichever is longer.
Prior anti-cancer therapy
Completion of last anti-cancer therapy must be at least 28 days prior to study drug administration.
Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
Anti-tumor therapy
Patients on concurrent anti-cancer therapy other than that allowed in the study
Anti-platelet drugs within 4 weeks prior to the first dose of study drug. Anti-platelet drugs are defined as any agent or combination of agents with clinically proven anti-thrombotic activity administered by any route with the purpose of affecting blood clotting ability of the subject.
Evidence of active infection, requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy < 7 days prior to administration of study medication
Prior anti-cancer treatment permitted (with specific criteria)
No previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if greater than 6 weeks of first day of study-defined treatment;
Previously received E7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in Phase Ib only);
Less than (<) 4 weeks since the last anti-tumor therapy prior to Day 1 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.
Subjects on anti-cancer medication whether biologic or pharmaceutical
Completion of last anti-myeloma therapy (if any) must occur at least 14 days before conditioning
Subjects on anti-cancer medication whether biologic or pharmaceutical
Anti-cancer therapy within 28 days prior to starting on therapy
Prior anti-cancer therapy within 28 days before the first dose of study drug
Received a new anti-cancer agent within 4 weeks prior to registration
No other investigational or standard anti-tumor therapy allowed
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
Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug
Patients must not be receiving anti-myeloma therapy (including maintenance therapy)
Patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations
Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists
Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
Patients must be anti-angiogenic therapy naive
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
Persistent acute toxicities from prior anti-cancer therapy.