Any prior treatment with any investigational drug within the preceding 4 weeks
Use of any investigational drug within the past 4 weeks
Prior treatment with any investigational drug within the preceding 2 weeks
Prior treatment with any investigational drug within the preceding 2 weeks
Have received prior treatment with any investigational drug within 4 weeks prior to dose assignment
Prior treatment with any investigational drug within the preceding 4 weeks
Participation in any investigational drug study within 4 weeks preceding enrollment
Has received treatment with any investigational drug in the previous 4 weeks
Investigational drug therapy outside of this trial during or within 3 weeks prior to C1D1.
The patient has received any investigational drug within the past 4 weeks
Taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration
Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
No investigational therapy within four weeks of the first dose of study drug.
Exposure to any investigational drug or placebo within 4 weeks of enrollment
Another investigational drug within 4 weeks of study drug administration
Treatment with an investigational anti-cancer study drug within 4 weeks prior to study drug administration date.
Administration of any investigational drug within 4 weeks prior to the first dose of study treatment
Exposure to any investigational drug within 4 weeks of study drug administration
Patients must not have received an investigational anti-cancer drug within two weeks of start of protocol treatment
Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period
Participation in another investigational drug study in the prior 4 weeks
Any investigational drug within 4 weeks
Prior treatment with any investigational drug within the preceding 4 weeks
Planned treatment, or treatment with any investigational drug within 4 weeks prior to screening.
No investigational therapy within 4 weeks of first dose of study drug
Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Treated with any investigational drug within 2 weeks of the first dose of study treatment.
Prior treatment with any investigational drug within the preceding 4 weeks prior to starting study drug
Any investigational drug < 6 weeks prior to the first dose of study drug or not recovered from effects of prior investigational agent
Another investigational drug within 4 weeks of study drug administration
Participation in any investigational drug study within 4 weeks preceding the start of study treatment; patients are not permitted to participate in another investigational drug study while being treated on this protocol
Exposure to any investigational drug within 4 weeks of study drug administration
Received other cancer treatment or investigational drug within 4 weeks prior to screening
Participation in another investigational drug study in the prior 8 weeks
Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Prior treatment with any investigational drug within the preceding 4 weeks
Treatment with any investigational drug within 2 weeks before first administration of present trial drug.
Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Prior treatment with any investigational drug within the preceding 4 weeks
Individuals who have received any investigational drug within 4 weeks
Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Have received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug
Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start
Investigational drug other than NEOD001 within 4 weeks
Use of any investigational drug within 4 weeks
No investigational drug within 4 weeks of starting study treatment.
Use of any investigational drug or treatment within 4 weeks prior to enrollment
Treatment with any investigational drug within 6 weeks of first dose of mirvetuximab soravtansine
Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Exposure to another investigational drug within 3 weeks prior to start of study treatment.
Discontinued prior systemic treatment or any investigational drug for at least 2 weeks (14 days) or for at least 3 weeks for IV anti-cancer drugs, prior to the study randomization
Treatment with an investigational drug within 3 weeks prior to the first dose of study drug
Participation in a study of an investigational drug within 4 weeks prior to the planned first day of study drug administration
Prior treatment with any investigational drug within the preceding 2 weeks
Received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug;
Treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial.
Prior treatment with any investigational drug within the preceding 4 weeks
Use of any investigational drug within the past 4 weeks before start of study medication or concomitantly with this study except for investigational immune-stimulatory therapy (e.g. checkpoint-regulator targeted treatment). The minimum washout period should be 8 weeks before starting the study medication.
Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Treatment with an investigational anti-cancer study drug within 3 weeks prior to study drug administration date
Treatment with any other investigational agent within 4 weeks (or within five half-lives of the investigational product, whichever is shorter) prior to cycle 1, day 1 (minimum of 1 week between prior therapy and study enrollment); patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre-phase I study” where a sub-therapeutic dose of drug is administered) at the coordinating center PI’s discretion, and should have recovered to eligibility levels from any toxicities
No treatment with any other type of investigational agent =< 4 weeks before pre-registration
Treatment with any other investigational agent within 4 weeks prior to randomization
Participants who are currently receiving any other investigational agents; treatment with an investigational agent within 2 weeks prior to planned initiation of study therapy is allowed provided that any drug-related toxicity has completely resolved
Treatment with another investigational agent under the following conditions:
Concomitant treatment with another investigational agent while participating this trial.
-  Treatment with an immunomodulatory agent within 4 weeks prior to first administration of BI 836858.
Previous treatment with any other investigational agent in the 4 weeks prior to study drug administration (Cycle 1 Day 1)
Investigational treatment - 4 weeks
Treatment with an investigational agent within 4 weeks of the first dose of treatment
SAFETY RUN-IN: Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study
Exposure to any other investigational agent at any time within 4 weeks before the first dose of study treatment
Treatment with any investigational agent within 4 weeks prior to baseline
Prior investigational therapy (medications or devices) within 6 weeks of treatment.
Subjects on treatment with chemotherapy or any investigational therapeutic agent will need to discontinue therapy 4 weeks prior to registration (wash out period)
Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
Other investigational therapy: at least two weeks since any other investigational therapy
Treatment with an investigational agent within 4 weeks of registration
Plans to initiate treatment with an investigational agent during the study
Treatment with any investigational agent within 14 days of first administration of study treatment is not permitted
Subjects who anticipate use of other investigational or non-investigational agents for the treatment of MDS during the study period, aside from a stable dose of erythropoietin stimulating agent started >8 weeks prior to screening for this study.
Treatment with any investigational agent within 28 days of first administration of study treatment.
Administration of any investigational agent within 4 weeks prior to initiating study treatment
Patients participating in another trial of an investigational agent within 4 weeks of the 1st dose of the study
Subject has received an investigational therapeutic agent for prostate cancer within 4 weeks prior to the administration of 131I-MIP-1095
An interval of >= 4 weeks after the last administration of any investigational agent or any other treatment prior to first dose of pembrolizumab
Administration of any investigational agent within 4 weeks prior to initiating study treatment
Concurrent treatment with any other investigational agent
Is currently participating in a study of an investigational agent and received an investigational agent within 4 weeks of the first dose of treatment
Treatment with any other investigational agent within 3 weeks prior to the first dose of MEDI4736 and tremelimumab
Any investigational agent within 4 weeks prior to initiating study treatment
Receipt of a prior investigational study agent within 4 weeks prior to enrollment; *Note- patients who have received anti-CD19 CART cells (e.g. CART19/cytotoxic T lymphocyte [CTL] 019) on an investigational study where cell infusion occurred greater than 4 weeks before the screening visit are NOT excluded
Received investigational treatment in another clinical study within 4 weeks prior to the initiation of investigational treatment;
Major surgery or treatment with any other investigational agent within 4 weeks
Any investigational agent within 4 weeks prior to initiating study treatment
Any investigational agent within 4 weeks of study treatment initiation
Patients may not receive concurrent treatment with other investigational or commercial agent(s) for treatment of their breast cancer
Use of any investigational agent within 4 weeks prior to study entry.
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs
Treatment with an investigational anti-cancer agent within 4 weeks prior to enrollment into the study
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs
Research participant must be at least 2 weeks out from having received the last dose of investigational agent
Use of any investigational agent within 4 weeks prior to the Baseline Visit.
Patients should not have received an investigational agent for at least 2 weeks prior to the first study drug dose
Investigational agent within 4 weeks of first dose of study treatment
Patients may not have used any investigational agent within 4 weeks prior to enrollment into the study
While on this study, patients may not be treated with any other investigational agent for any purpose until relapse or progression
Treated with any investigational therapy within 2 weeks of the first dose of study treatment.
Administration of any unlicensed or investigational agent within 4 weeks of entry to the study
No prior investigational agent in the 4 weeks prior to initiation of therapy
Use of any investigational agent within 4 weeks prior to study entry.
4 weeks from any investigational agent
Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
Less than 4 weeks since use of another investigational agent
Treatment with any investigational agent within 4 weeks prior to baseline
Treatment with any investigational agent within 4 weeks prior baseline
Patients who have received treatment with any other investigational agent within 4 weeks before initiation of study treatment
Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks prior to first administration of IMP and during study with exceptions
Treatment with any other investigational anti-leukemia agent
Non-nitrosourea cytotoxic drug or any systemic investigational agent with exception of methotrexate ? 4 weeks
Any investigational agent(s) within 4 weeks prior to entry
Treatment with any other investigational agent or investigational device within 4 weeks prior to registration (or within five half-lives of the investigational product, whichever is longer); patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an “early phase I study” or “pre phase I study” where a sub- therapeutic dose of drug is administered) at the coordinating center principal investigator (PI)’s discretion, and should have recovered to eligibility levels from any toxicities
Treatment with other investigational agent within 4 weeks to the first dose of tremelimumab or durvalumab
Investigational therapy within 3 weeks.
Concurrent administration of any other investigational agent considered to have potential efficacy in the treatment of breast cancer
Any investigational agent within 4 weeks prior to initiating study treatment
Ongoing treatment with any other cancer therapy or investigational agent, with the exception of intrathecal (IT) chemotherapy for leukemia, when indicated
Concurrent treatment with an investigational agent
An interval of >= 4 weeks after the last administration of any investigational agent, bevacizumab, or prior cytotoxic therapy
Subjects having received any other investigational agents within 4 weeks prior to the\n             first study drug administration and have not recovered completely (to AEs <  Grade 2)\n             from the side effects of the earlier investigational agent
Treatment with any investigational agent within two weeks prior to first dose in this study; hydroxyurea is allowed to control the AML prior to treatment on the study
Patients with a history of prior therapy with another investigational agent within 4 weeks of the first planned dose of PF-0444913
Concurrent treatment with an investigational agent other than the investigational agent(s) used in this study OR treatment within 4 weeks of study entry with any investigational agent(s) or device(s)
Prior chemotherapy (except PLD in Dose Escalation Cohorts only) or any investigational agent within 3 weeks prior to registration
Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.
Any investigational agent within 3 weeks of Day 1 of trial drug treatment
First day of dosing with tesevatinib is less than 2 weeks from treatment with another investigational agent
Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.
No investigational agent within 4 weeks prior to first dose of study drug.
Have been treated with an investigational agent within 4 weeks prior to the first day of IP administration.
Treatment with radiotherapy, any chemotherapeutic agent, systemic steroids used as an anti-neoplastic agent, or any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
Treatment with any other investigational agent
Treatment with an investigational agent within 4 weeks of starting treatment.
Treatment with any systemic anticancer treatment or an investigational agent within 4 weeks and any radiation within 2 weeks of registration
Treatment with any investigational agent within three weeks prior to first dose in this study
Treatment with any investigational agent within 28 days of first administration of study treatment
Treatment with any investigational agent within three weeks prior to first dose in this study
Taking an investigational agent within 4 weeks of initiation of everolimus
Administration of an investigational agent within 4 weeks of Treatment Cycle 1, Day 1
At least 4 weeks must have elapsed from the use of any other investigational agent prior to starting study drug
Treatment with investigational therapy within 2 weeks of study treatment
If a subject previously received investigational treatment, the last dose of investigational treatment was administered within 4 weeks of Day 1 of the study or adverse event(s) attributable to investigational treatment have not resolved to Grade 1 or better.
Use of any investigational agent within 4 weeks prior to study entry.
Patients who have participated in a window study (treatment with an investigational agent prior to surgery for =< 2 weeks) are eligible; patients must have discontinued the investigational agent at least 14 days before participation
Treatment with an investigational agent within 4 weeks before dosing
Treatment with any investigational agent within 14 days of first administration of study treatment
Ongoing treatment with any other investigational therapy
Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrolment
No use of an investigational agent within 2 weeks of starting ECP
Current active treatment with an investigational agent
complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent and 6 months after the last dose of study agent; or
Any investigational agent within 4 weeks of first dose of study treatment
Any investigational agent, other than NEOD001, within 4 weeks
Ongoing investigational treatment
Use of an investigational agent within 4 weeks of Day 1 visit.
Other investigational agent within 3 weeks prior to initiation of study therapy
Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy.
Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy.
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs
Receipt of any investigational agent within 4 weeks prior to 1st dose
Treatment with any investigational agent within 3 weeks prior to first dose in this study.
Treatment with another investigational agent under the following conditions:
Concomitant treatment with another investigational agent while participating in this trial.
Current treatment with another investigational agent.
More than 4 weeks from any investigational agent.
Ongoing treatment with any other investigational therapy
Concurrent treatment with an investigational agent
Treatment with any investigational agent <=3 weeks prior to first dose of study treatment
Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
Patients may not have received an investigational agent within 4 weeks of starting this trial
Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment
Received an antineoplastic therapy or investigational agent after treatment with talazoparib in the originating protocol.
Patient is using or plans to use an investigational agent for the prevention or treatment of VOD.
Concurrent treatment with other investigational agent
Treatment with any local or systemic anti-neoplastic therapy or any other investigational agent in the 4 weeks prior to study drug administration
2 weeks since any oral anti-neoplastic or oral investigational agent
use of any investigational drug within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent)
Patients who have been treated with chemotherapy, with biological therapy or other investigational agent must have discontinued the treatment at least 2 weeks (14 days) prior to starting the study drug on Study Day -
No investigational agent within 4 weeks prior to first dose of study drug
Patients may not receive any non-oncology vaccine therapy during the period of NEO PV-01 or pembrolizumab administration and until at least 8 weeks after the last dose of the booster vaccine. Seasonal influenza vaccines are allowed but may not be administered between the first dose of pembrolizumab and the last booster dose of NEO-PV-01
Anticancer Vaccine -2 months NOTE: The subject should be excluded if the Investigator considers their disease is responding to an experimental vaccine given within 6 months
Prior treatment with a cancer vaccine for this indication
Prior treatment with Provenge vaccine and 223 radium (Xofigo) is allowed if > 4 weeks from last dose
Insufficient tumor available to produce vaccine
Patients must be off corticosteroid for at least for 2 weeks before the first neoadjuvant vaccine and for at least 2 weeks prior to the first adjuvant vaccine
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-human chorionic gonadotropin [HCG]) prior to administration of the first vaccine dose. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. Women must also not be breast feeding. This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
Subjects vaccinated with a live (attenuated) vaccine (e.g., FluMist) or a killed (inactivated)/subunit vaccine (e.g., PNEUMOVAX, Fluzone) within 28 days or 14 days, respectively, of the first planned dose of ETBX vaccine
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with avelumab or within 5 months after the last dose of avelumab\r\n* Attenuated live vaccines include but are not limited to:\r\n** Tuberculosis (Bacillus Calmette-Guerin [BCG])\r\n** Oral polio vaccine\r\n** Measles, mumps, rubella, alone or as part of measles/mumps/rubella vaccine (MMR)\r\n** Rotavirus\r\n** Yellow fever\r\n** Typhoid\r\n** Rabies vaccine should be utilized as recommended by an infectious disease specialist\r\n** Nasal flu vaccine
Subjects who received non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration
Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment.
Prior use of an immunotherapy such as (but not limited to) a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapy
Non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration
Receipt of any prior therapy for CLL. Patients who have received “early intervention” with INVAC-1 vaccine against hTERT will be eligible provided all of the following exist: i) They had no response to the vaccine treatment (persistent CLL > 1% in bone marrow). ii) ·3 months have elapsed since the last dose of vaccine. iii) No residual toxicities attributable to the vaccine exist at the time of study enrollment. iv) The patient does not meet IWCLL criteria for requiring treatment.
Use of an immunotherapy such as a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapy
Any live vaccine or non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab).
Prior therapy with tumor vaccine
Prior therapy with talimogene laherparepvec, tumor vaccine
The patient must have received a boost immunization with trivalent inactivated poliomyelitis vaccine (IPOL) (Sanofi-Pasteur) >= 1 week prior to administration of the study agent
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab)
Known allergy or hypersensitivity to tetanus, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine (i.e., aluminum phosphate, formaldehyde)
Insufficient tumor available to produce vaccine
No previous severe allergic reaction to hepatitis B vaccine, polio vaccine or tetanus, diphtheria, pertussis vaccine (DTP, Tdap, DT or Td)
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: No previous severe allergic reaction to hepatitis B vaccine, polio vaccine or tetanus, diphtheria, pertussis vaccine (DTP, Tdap, DT or Td)
Any non-oncology vaccine therapies used for the prevention of infectious disease within 28 days prior to enrollment and during treatment period
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab)
Allergy or hypersensitivity to tetanus vaccine or any component of the tetanus vaccine
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)\r\n* Subjects may receive flu vaccine at any time before or during the study
Males and females must agree to use effective birth control methods during the course of vaccination (from the first vaccine to two weeks after the last vaccine)
Tetanus vaccine during therapy or within 1 week prior to enrollment
Any non-oncology live vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab).
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
No non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Prior therapy with tumor vaccine
Prior oncology vaccine therapy
Any prior immunotherapy or vaccine therapy
Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to four weeks (28 days) prior to or after any dose of ipilimumab; NOTE: Patients are permitted to receive the seasonal influenza vaccine; if seasonal influenza vaccine is considered, killed vaccines should be recommended
Prior investigational melanoma-directed cancer vaccine therapy
Use of a non-oncology vaccine therapy for prevention of infectious diseases during the 4 week period prior to first dose of NeoVax administration; patients may not receive any non-oncology vaccine therapy during the period of NeoVax administration and until at least 8 weeks after the last dose of study therapy
No prior vaccine therapy
Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab/vaccine)
No stereotactic radiation therapy within 3 days of first vaccine
No chemotherapy within 4 weeks of first vaccine administration
No targeted therapy within 2 weeks of first vaccine administration
No immunomodulatory therapy within 2 weeks of first vaccine administration
During Screening period, no steroid therapy within 4 weeks of first vaccine administration
Non-antibody immunotherapy (e.g., tumor vaccine) At least 42 days
Non oncology vaccine therapies for prevention of infectious disease (for example, seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of trial drug administration. Vaccination while on trial is also prohibited except for administration of inactivated vaccines (for example, inactivated seasonal influenza vaccine)
Patients are excluded for any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Non-antibody immunotherapy (e.g., tumor vaccine); at least 42 days since last dose
Subjects who have received any non-oncology live vaccine therapy used for prevention of infectious diseases for up to 28 days prior to or after the initiation of treatment in this study
Any non-oncology live or attenuated vaccine therapy used for prevention of infectious diseases within 30 days prior to the first dose of tremelimumab; if patients is enrolled, patient should not receive live vaccine during the study and 180 days after the last dose of tremelimumab
History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine) within the last year
Use of an immunotherapy such as a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapy
No vaccination against N. meningitidis types A, C, W, Y and B (administered as two separate vaccinations), Pneumococcal conjugate vaccine or Pneumococcal polysaccharide vaccine 23 (PCV13 or PPSV23, respectively) and Haemophilus influenzae Type B (Hib) vaccination within 2 years prior to Day 1 (Visit 2) dosing.
Received non-oncology vaccine therapy for prevention of infectious diseases during the 4-week period prior to first dose of nivolumab therapy. Patients may not receive any non-oncology vaccine therapy during the period of NEO-PV-01 + adjuvant or nivolumab administration and until at least 8 weeks after the last dose of the booster vaccine. Annual influenza vaccines are allowed during screening and pre-treatment but not during nivolumab or NEO-PV-01 + adjuvant dosing.
Subjects vaccinated with a live (attenuated) vaccine (e.g., FluMist) or a killed (inactivated)/subunit vaccine (e.g., PNEUMOVAX, Fluzone) within 28 days or 14 days, respectively, of the first planned dose of ETBX vaccine
Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose
Patients must not have live vaccine therapies for prevention of infectious diseases within 28 days of first nivolumab dose
History of listeriosis or vaccination with a listeria-based vaccine or prophylactic vaccine (example influenza, pneumococcal, diphtheria, tetanus, and pertussis [dTP/dTAP]) within 28 days of study treatment
Prior treatment with a cancer vaccine for this indication
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose
COHORT A: Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab); Note: inactivated vaccines are allowed at any time on study
COHORT B: Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab); Note: inactivated vaccines are allowed at any time on study
Prior treatment with a cancer vaccine for this indication
Non-oncology vaccine therapies for prevention of infection disease (e.g. seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of study drug administration. Vaccination while on study is also prohibited except for administration of the inactivated influenza vaccine.
Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 1 month before BPX-201
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Prior adverse reaction to diphtheria vaccine
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
The patient must have received a boost immunization with trivalent inactivated poliovirus vaccine (IPOL) (Sanofi-Pasteur) at least 1 week prior to administration of the study agent
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks before or after any dose of ipilimumab
Patients who had received one or more doses of the pneumococcal polysaccharide vaccine (PPSV)23 vaccine in the previous 12 months
At least 2 doses of fusion vaccine were produced
Participation in a previous vaccine trial
Persistent, unexplained increases in absolute eosinophil count prior to initiation of vaccine
Previous exposure to heat inactivated measles virus vaccine (this vaccine was given to some individuals between the years of 1963-1967)
Administration of any other vaccine ? 4 weeks of receiving cyclophosphamide on Day -3
Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks (28 days) prior to or after any dose of ipilimumab
Administration of any vaccine ? 4 weeks prior to first maintenance or retreatment cohort dose of ONT-10 with the exception of influenza, pneumococcus, and Tdap
Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
Any non-oncology live viral vaccine therapies used for the prevention of infectious diseases.
Prior treatment with a cancer vaccine
Use of an anti-cancer vaccine within 2 months in the absence of tumor response, or the subject should be excluded if their disease is responding to an experimental vaccine given within 6 months.
Women who have received typhoid vaccine within three years or any other vaccine within three months will be excluded
History of listeriosis or vaccination with a listeria-based vaccine or prophylactic vaccine (eg, influenza, pneumococcal, diphtheria, tetanus, and pertussis [dTP/dTAP]) within 28 days of study treatment
Patients with severe allergic reaction (e.g., anaphylaxis) after previous dose of any influenza vaccine or to a vaccine component, including egg protein
History of receiving 2016-2017 influenza vaccine
FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: History of receiving current year seasonal influenza vaccine influenza vaccine
Female, and a) currently pregnant or lactating, or b) of childbearing potential and unwilling to avoid pregnancy during the vaccine phase of study (beginning at day 1 and continuing until at least 4 weeks after all 3 vaccine doses have been administered)
History of receiving 2017-2018 influenza vaccine
SUBJECTS ENROLLED IN THE TREATMENT GROUPS RECEIVING VACCINE ONLY (NOT THE IMIQUIMOD GROUP):
3. Administration of any vaccine within 4 weeks of the first study treatment
Administration of any vaccine within 8 weeks of enrollment and within 4 weeks for flu vaccine.
Vaccine based therapy: 3 months
Vaccine-based and/or viral therapy: 3 months
Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine.
Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
Inclusion Criteria:\n\n        Study entry (enrollment) occurs at the Pre-vaccination visit.\n\n          -  Subjects who the investigator believes can and will comply with the requirements of\n             the protocol.\n\n          -  Written informed consent obtained from the subject.\n\n          -  A male or female aged 18 years or older at the time of study entry.\n\n          -  Has undergone or will undergo autologous HCT within 50-70 days prior to the first\n             vaccination with the study vaccine/placebo, and there are no plans for additional\n             HCTs.\n\n          -  Female subjects of non-childbearing potential may be enrolled in the study. For this\n             study population, non-childbearing potential is defined as current tubal ligation,\n             hysterectomy, ovariectomy or post-menopause.\n\n        OR Female subjects of childbearing potential may be enrolled in the study, if the subject\n        has practiced adequate contraception for 30 days prior to vaccination with the study\n        vaccine/placebo, and has a negative pregnancy test on the day of vaccination, and has\n        agreed to continue adequate contraception during the entire treatment period and for 12\n        months after completion of the vaccination series (i.e., until Month 13).\n\n        Exclusion Criteria:\n\n          -  Use of any investigational or non-registered product other than the study vaccine\n             within 30 days preceding the first dose of study vaccine/placebo, or planned use\n             during the study period. However, the investigational use of a registered or\n             non-registered product to treat the subject's underlying disease for which the HCT was\n             undertaken, or a complication of the underlying disease, is allowed.\n\n          -  Previous vaccination against HZ or varicella within the 12 months preceding the first\n             dose of study vaccine/placebo.\n\n          -  Planned administration during the study of a HZ vaccine other than the study vaccine.\n\n          -  Occurrence of a varicella or HZ episode by clinical history within the 12 months\n             preceding the first dose of study vaccine/placebo.\n\n          -  History of allergic disease or reactions likely to be exacerbated by any component of\n             the vaccine or study material and equipment.\n\n          -  Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV)\n             expected to last more than 6 months after transplantation.\n\n          -  Administration and/or planned administration of a vaccine not foreseen by the study\n             protocol between HCT and 30 days after the last dose of study vaccine/placebo.\n             However, licensed non-replicating vaccines may be administered up to 8 days prior to\n             dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo.\n\n          -  HIV infection by clinical history.\n\n          -  Pregnant or lactating female.\n\n          -  Female planning to become pregnant or planning to discontinue contraceptive\n             precautions (if of childbearing potential) before Month 13 (i.e., one year after the\n             last dose of study vaccine/placebo).
A subject previously enrolled in study NCT00294047, who received the control vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the age for which the vaccine is licensed.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days (i.e., Day 0-29) of each dose of vaccine, with the exception of administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine. Enrolment will be deferred until the subject is outside of specified window.
Previous administration of any components of the vaccine.
Male subjects who are not employing an effective method of birth control from starting vaccine, including dosing interruptions through 90 days after receipt of the last vaccine; refrain from sperm cell donation while receiving vaccination and for at least 90 days after the last vaccine
Has taken any live vaccinations within 30 days before study drug administration except for the influenza vaccine.
Non-oncology vaccine therapies for prevention of infectious diseases (example, human papillomavirus [HPV] vaccine) within 4 weeks of study drug administration. The inactivated seasonal influenza vaccine can be given to participants before treatment and while on therapy without restriction. Influenza vaccines containing live virus or other clinically indicated vaccinations for infectious diseases (example, pneumovax, varicella) may be permitted but must be discussed with the sponsor's medical monitor and may require a washout period before and after administration of vaccine.
Prior treatment with a tumor vaccine.
Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration
Patients who are receiving any other chemotherapy or investigational agents; radiation treatment will not be permitted during study treatment; patients can receive radiation therapy (XRT) 4 weeks prior to study drug administration or 4 weeks post study completion or discontinuation; steroids equivalent to prednisone 60 mg daily are permitted prior to study drug administration, but needs to be discontinued 1 day prior to BV administration; patients receiving steroids for lymphoma symptoms should have measurable disease as mentioned above on baseline scans
Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug
Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
ELIGIBILITY CRITERIA - PHASE II (ARM D): Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent\r\n* Patients with WBC count above 20 x10^9/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day 1 of study drug
Any chemotherapy within the 28 days prior to the first dose of study drug.
Patient has had chemotherapy within 28 days prior to first administration of study drug.
Immunomodulating agents <28 days prior to first dose of study drug
Steroid treatment within seven (7) days prior to study treatment. Patients that require intermittent use of bronchodilators, topical steroids or local steroid injections will not be excluded from the study. Patients who have been stabilized to 10 mg PO QD or less seven (7) days prior to study drug administration are allowed.
No previous treatment with the specific assigned study drug or any other drug sharing the same target; prior treatment in monotherapy when treated in one of the combination arms in the study is allowed
Prior definitive radiation therapy must have been completed at least 6 weeks before study drug administration and the irradiated lesions should show evidence of progression if they are intended to be considered target lesions. Prior palliative radiotherapy must be completed at least 2 weeks before study drug administration. The radiotherapy-related side effects must have resolved before the study entry. No radiopharmaceuticals (strontium, samarium) will be allowed within 8 weeks before study drug administration.
Chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from clinically significant adverse events due to cancer therapeutics administered more than 4 weeks prior to the first dose of study drug
Treatment with antibiotics within 14 days prior to first dose of study drug.
Is pregnant or breast feeding or expecting to conceive or father starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication
Participant has had prior antineoplastic therapy within 14 days prior to starting study drug.
Participant that received in the 7 days prior to the administration of study drug or is currently receiving any of the following medications:
No previous treatment with the specific assigned study drug or any other drug sharing the same target
History of any of the following within the last 6 months before administration of the first dose of the study drugs:
Has had any major cardiovascular event within 6 months prior to study drug administration
Use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.
Neurological stability for at least 14 days prior to first dose of study drug;
Significant mental illness in the 4-week period preceding drug administration.
Patients must not have received any vaccines for 28 days prior to administration of their first dose of MT-3724 and should not receive any vaccine during the study or within 28 days after their last dose of MT-3724.
Last dose with any of the following agents including but not limited to: etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab <28 days prior to first dose of study drug
Female subjects who are breastfeeding, or intend to breastfeed during the duration of the study and for 30 days following the last dose of study drug.
Breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Treatment with therapeutic doses of metaiodobenzylguanidine (MIBG) ?6 weeks before first dose of study drug
Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug administration until 90 days after the last dose of study drug.
Non-sterile male subjects must use contraceptive methods with partner(s) prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug; male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug
Participants may not concomitantly use statins while on study; however, a patient using statins for over 3 months prior to study drug administration and in stable status without CK rise may be permitted to enroll
Patients who have had chemotherapy within 2 weeks prior to first dose of study drug.
CLL therapy, with the exception of ibrutinib within the following timeframes:\r\n* Chemotherapy, external beam radiation therapy, anticancer antibodies within 30 days prior to the first dose of drug on this study\r\n* Corticosteroid use >= 20mg prednisone within 1 week prior to first dose on this study\r\n* Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose on this study\r\n* Allogeneic stem cell transplant within 6 months prior to first dose on this study
Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpetation of study results.
Received hydroxyurea therapy within 28 days (4 weeks) before the first dose of any study drug
Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
There are no prohibitions of specific medications on the basis of anticipated drug-drug interactions
Systemic antineoplastic therapy or radiotherapy within 14 days before the first dose of any study drug, except for hydroxyurea
Breastfeeding should be discontinued until 6 weeks after the last administration of study drug
Surgery within 4 weeks of study drug administration
History of any of the following within the last 3 months before administration of the first dose of study drug:
Subject has no significant worsening in clinical status for a minimum of 7 days prior to first dose of study drug.
At least 84 days must have elapsed after stem cell infusion prior to study drug administration
Phase 1: Received prior therapy with eribulin mesilate within 6 months prior to study drug administration.
Laparoscopic procedure or open biopsy within 7 days prior to study drug administration
The following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug:\r\n* Patients who are actively receiving any other investigational agents\r\n* Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug\r\n* Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug\r\n* Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib, obinutuzumab or Revlimid), excluding prior prednisone or rituximab treatment\r\n* Prior allogeneic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug\r\n* Not recovered (i.e., =< grade 1 or baseline) from adverse events due to previously administered anti-cancer treatment, surgery, or procedure; NOTE: exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the principal investigator (PI) (e.g., alopecia)
Within 14 days of the first dose of study drug: Platelets >= 100,000/·L
Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug
Serum creatinine =< 1.5 x ULN (results within 7 days before study drug administration)
To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug.
Anti-cancer therapy less than 14 days prior to the first dose of study drug (less than 28 days for bevacizumab) or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug
Anti-cancer therapy less than 6 weeks prior to the first dose of study drug (less than 28 days for bevacizumab) or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug
Patients scheduled for definitive cancer surgical resection less than 7 days from beginning of study drug administration or greater than 6 weeks from beginning of study drug administration
At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
Anti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug
Patients who have received systemic nonsteroidal antiinflammatory drug (NSAID) therapy within 14 days prior to the first dose of study drug
Patients being treated with medications with drug-drug interactions with study agents will require evaluation by to determine if full doses of all study treatments can be given safely; significant drug-drug interactions will need to be addressed prior to enrollment; alternatively, the patient will not be eligible
Patients receiving anti-retroviral therapy or other agents that are contra-indicated with nelfinavir due to drug-drug interactions
Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug. Following major surgeries, >4 weeks prior to the first dose of study drug, all surgical wounds must be healed and free of infection or dehiscence.
History of any of the following within the last 6 months before administration of the first dose of study drug:
Patients scheduled for definitive cancer surgical resection less than 7 days from beginning of study drug administration or greater than 5 weeks from beginning study drug administration
Treatment with any of the following within the specified time frame prior to the study drug administration:
Prior major surgery must be completed at least 4 weeks before study drug administration; prior minor surgery must be completed at least 1 week before study drug administration and subjects should be recovered; percutaneous biopsies should be completed at least 10 days prior to study drug administration
ENTRECTINIB EXCLUSION CRITERIA: Pulmonary embolism in the 3 months prior to study drug administration
Within 14 days of first dose of study drug administration: Platelets >= 100,000/mcl
Pharmacologic therapy with agents reported to produce adverse drug-drug interactions. (Table 2)
Administration of agents with potential QT interval prolonging effects within 14 days prior to the first administration of study drug and while on treatment
Participants who have received any of the following prior to the first dose of study drug:
Radiation therapy within four weeks prior to administration of the first dose of study drug • To be eligible for study treatment, radiation therapy-related toxicity must recover to Grade ? 1 prior to administration of the first dose of study drug. Concurrent palliative radiotherapy for local pain-control may be allowed, provided the subject does not meet criteria of progressive disease and treated lesions will not be included in the target/non-target lesion assessment.
Any of the following within 6 months prior to study drug administration:
Baseline serum PSA value performed with an Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration
Less than or equal to (</=) 96 hours between onset of ILI and first dose of study drug
Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Received radiotherapy ?14 days prior to the first dose of AP32788 of study drug.
Participants in Study Part C must have HR+ breast cancer, NSCLC, or melanoma with brain lesions clinically indicated for surgical resection as well as consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.
Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration
Laparoscopic procedure or open biopsy within 7 days prior to study drug administration
Received study contraindicated medications prior to study drug administration including but not limited to those listed in the Full Prescribing Information Sheet for ledipasvir/sofosbuvir (Harvoni®).
Subjects of childbearing potential must consent to utilize a medically accepted means of contraception throughout the active dosing period with study medication and for a minimum of 30 days following the administration of the last dose of study medication.
Must be willing to implement contraception throughout study and for 120 days after receiving the study drug.
Medical history of RBC transfusion dependent anemia ?4 units of RBCs during the 16 weeks prior to admin of study drug & ?2 units of RBCs over prior 8 weeks (day -56 to day 1 prior to treatment; baseline period) for documented Hgb of ? 9g/dL (during baseline). Didn't have a 56 day RBC transfusion-free period during 16 weeks prior to administration of study drug.
Within 14 days of first dose of study drug: Platelets > 100 x 10^9/L
Appropriate for single agent study drug therapy as prescribed by this protocol;
Patient has any of the following within 14 days prior to the first dose of study drug:
TREATMENT: Breastfeeding should be discontinued while the patient is on this trial and for 30 days following last dose of study drug
Must be willing to implement contraception throughout study and for the 4 weeks following last viral administration
Had involvement in the planning and/or conduct of the study by association with the sponsor, study drug supplier(s) or study center or was previously enrolled in the present study
Non-study related surgical procedures less than or equal to 7 days prior to\n             administration of rociletinib. In all cases, the patient must be sufficiently\n             recovered and stable before treatment administration
Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before first dose of study drug
Prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration; prior focal radiotherapy completed at least 2 weeks before study drug administration; no radiopharmaceuticals (strontium, samarium) within 8 weeks before study drug administration
Completed nitrosourea treatment at least 6 weeks before administration of any study drug
Prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration\r\n* Prior focal radiotherapy completed at least 2 weeks before study drug administration\r\n* No radiopharmaceuticals (strontium, samarium) within 8 weeks before study drug administration
Completed nitrosourea treatment at least 6 weeks before administration of any study drug
Patient is currently participating or has participated in a study with an investigational compound or devise within 30 days of initial dosing with study drug(s)
Subject is suitable for oral administration of study drug.
Immunostimulants within 4 weeks or immunosuppressants within 14 days prior to study drug
Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
Completion of, if applicable, radiotherapy, chemotherapy, antibodies and immunoconjugates including brentuximab vedotin and/or another investigational drug which could interact with this trial not less than 4 weeks (or 5 half-lives of the drug, whichever occurs later) prior to first dose of study drug. Cessation of small molecule tyrosine kinase inhibitors must be at least 7 days prior to first dose of study drug.
Male patients must use a condom from the time of the first administration of ONO-7475 until 4 months following administration of the last dose.
Time required between the last dose of the latest therapy and the first dose of study drug:
Subject must currently be participating in an Astellas sponsored, single agent ASP2215 trial, receiving ASP2215 and have not met any discontinuation criteria of the parent study and can enroll into this rollover study without interruption of study drug, or with no more than 2 weeks interruption in study drug.
Pleurodesis within 14 days prior to first dose of study drug
Prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration; prior focal radiotherapy completed at least 2 weeks before study drug administration; no radiopharmaceuticals (strontium, samarium) within 8 weeks before study drug administration
Completed nitrosourea treatment at least 6 weeks before administration of any study drug
History of any of the following within the last 6 months before administration of the first dose of study drug
Breastfeeding should be discontinued until 6 weeks after the last administration of study drug
Surgery within 4 weeks of study drug administration
Use of any investigational, non-United States Food and Drug Administration (US FDA) approved drug
Patients who have received any investigational agent, chemotherapy, interferon-alpha, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to day 1; or monoclonal antibody =< 6 weeks prior to first administration of study treatment (patients with an AHNMD with progressive leukocytosis who require control of their counts are permitted to be given hydroxyurea); EXCEPTION: midostaurin can be used up to 10 days before the start of the study drug (study day 1)
Received prior systemic cytotoxic chemotherapy, biological therapy, major surgery within 3 weeks of first dose of study drug; received thoracic radiation therapy of > 30 gray (Gy) within 6 months of first dose of study drug
Currently receiving or has received any intensive chemotherapy within the 14 days prior to the first dose of study drug (day -7) (Hydrea or other non-intensive regimens such as decitabine may be used but must stop at least one day prior to the first dose of study drug)
Acceptable laboratory assessment obtained within 14 days prior to the first dose of study drug:
Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of >30 Gy within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug
Subject is suitable for oral administration of study drug.
Treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
Received any subsequent anti-cancer therapies from the time between the last dose of atezolizumab prior to the first administration of study drug after crossing over
Whole brain radiation within 28 days or other radiotherapy within 14 days prior to first administration of study drug after crossing over
Treatment with non-Food and Drug Administration (FDA) approved drug within 21 days of start of this trial
Treatment with a non-Food and Drug Administration (FDA) approved drug in the previous 4 weeks
Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 180 days after the last dose of study drug.
Patient who has had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study drug
Radiotherapy within 14 days before the first dose of study drug.
Radioimmunotherapy within 4 weeks before first dose of study drug
FOCBP must have a negative pregnancy test within 7 days prior to registration on study\r\n* Note: female patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Subject is suitable for oral administration of study drug.
Patient who has had chemotherapy, or biological cancer therapy within 2 weeks prior to the first dose of study drug; patient who has had radiation within 2 weeks prior to the first dose of study drug
Female subjects of child-bearing potential must agree to undergo medically supervised pregnancy test prior to starting study drug. The first pregnancy test will be performed at screening (within 7 days prior to first study drug administration), and on the day of the first study drug administration and confirmed negative prior to dosing and Day 1 before dosing all subsequent cycles.
Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment; immunotherapy, radiotherapy or experimental therapy within 28 days of first day of study drug dosing, or within six weeks of first day of study drug dosing in the event that nitrosoureas or mitomycin were used; concurrent systemic immunosuppressant therapy other than corticosteroids (e.g. cyclosporine A, tacrolimus, etc) must be discontinued within 28 days of the first dose of study drug
Patients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of 28 days prior to registration from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:\r\n* 14 days from administration of vincristine\r\n* 42 days from administration of nitrosoureas\r\n* 21 days from administration of procarbazine
discontinued previous monoclonal antibody therapy (except rituximab) or radioimmunotherapy administration for at least 60 days before study drug administration.
At the time of trial enrollment, participants may be receiving one or two other immunosuppressive therapies in addition to glucocorticoids; immunosuppressant doses must be stable for 14 days prior to starting study drug; monoclonal T or B cell antibodies must be discontinued at least 28 days before starting study drug
Have taken certain medications or had grapefruit juice within 7 days of initial dose of study drug, as levels of the study drug may be affected.
A woman who is pregnant or breast feeding, or a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Any prior therapy for castrate disease is acceptable except prior abiraterone, which is excluded; a minimum washout of 28 days for any other anticancer therapy prior to first dose of study drug is required\r\n* Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug\r\n* Denosumab or zoledronic acid are allowed
Ability to receive study drug therapy by enteral administration
Plan to father a child while enrolled in this study or within 90 days after the last dose of study drug.
For women of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to 90 days following the last study drug administration
Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. • Agree not to share study medication with another person.
Subject has received intervening anticancer treatment or previous treatment with chemotherapy for metastatic disease other than palliative local radiation to painful bone metastases completed at least 1 week prior to the first dose of study drug. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized ? 6 months before the first dose of study drug.
Must be willing to implement contraception throughout study and for the 8 weeks following last study drug administration.
Use of drugs that might pose a risk of a drug-drug interaction within 4-7 days before the start of study therapy.
Agree not to share either study drug with another person.
Non-study related surgical procedures less than or equal to 7 days prior to administration of study drug. In all cases, the patient must be sufficiently recovered and stable before treatment administration.
Subject has any of the following within 14 days prior to the first dose of study drug:
Subject has received the following within 14 days prior to the first dose of study drug:
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 28 days prior to the first administration of study drug and agree to use highly effective physician-approved contraception from 30 days prior to the first study drug administration to 90 days following the last study drug administration
Male subjects must be surgically sterile or must agree to use highly effective physician-approved contraception from 30 days prior to the first study drug administration to 90 days following the last study drug administration
Received any of the following within the specified time frame prior to the first administration of study drug:
Subject has history of gastrointestinal ulcer within 28 days prior to the first dose of study drug.
Prior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before the first administration of study drug, and the participant must have documented progressive disease.
Has taken histamine-H2 receptor antagonists and/or neutralizing antacids within 24 hours before the first administration of study drug.
Poor venous access for study drug administration; in this case, patients would require a peripheral or central indwelling catheter for study drug administration; study drug administration via indwelling catheters is prohibited at this time unless silicone based catheters are used; anything other than catheters made from silicone are not allowed with ganetespib therapy
Therapy with samarium-153, strontium-89, or radium-223 within 8 weeks prior to first dose of study drug.
Participated in another drug study within 90 days before this one
Currently enrolled in (or completed within 30 days before study drug administration)another investigational drug study.
Currently enrolled in (or completed) another investigational drug study within 30 days prior to study drug administration
Antineoplastic therapy, radiotherapy, or any other investigational drug within 30 days prior to first study drug administration
Unable to return at the regular required intervals for reassessment, or study drug administration
Previous radiotherapy (unless brachytherapy), endocrine therapy, chemotherapy, or exposure to investigational medicinal products during the 4 weeks (6 weeks for nitrosoureas and Mitomycin-C) or 4 drug half-lives before the planned administration of the first dose of study drug, whichever is greater. Previous immunotherapy during the 4 weeks before the planned administration of the first dose of study drug.
Male subjects with pregnant or lactating partners or partners who plan to become pregnant while on study or within 6 months after the planned administration of the last dose of study drug
Systemic investigational drug of any kind within 6 weeks of AVB-620 administration
Patient has an infection and has had a body temperature of > 38.3?C within 48 hours prior to planned first dose of study drug.
surgery, radiation, or immunosuppressants within 28 days prior to planned first dose of study drug,
mitomycin-C or nitrosoureas within 42 days prior to planned first dose of study drug. Note: Patients receiving LHRH agonists or antagonists or antiestrogens or aromatase inhibitors started and at a stable dose for at least 90 days prior to planned first dose of study drug are eligible. Patients are permitted one 28 day cycle of concurrent treatment with hydroxyurea during the study.
Required screening laboratory data (within 2 weeks prior to administration of study drug) as shown in study protocol.
Subject has had any of the following within 14 days prior to the first dose of study drug:
Radiotherapy within 14 days before the first dose of study drug.
Any of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of either study drug):
Poor venous access for study drug administration\r\n* Study drug administration via indwelling catheters is allowed only if the catheter is made of silicone material
Planned treatment with NovoTTF therapy alone per Food and Drug Administration (FDA)-approved indication; NovoTTF therapy must start within 14 days of registration, but not less than 7 days or more than 21 days from stereotactic biopsy (if applicable) and not less than 21 days or more than 42 days from open resection (if applicable)
High-dose chemotherapy within 4 weeks of study drug
Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration;
Subject has received aspirin or warfarin within 7 days prior to the first dose of study drug
Systemic antineoplastic therapy or radiotherapy within 14 days before the first dose of study drug, except for hydroxyurea
WCBP must agree to have pregnancy tests monthly (every 14 days for women with irregular cycles) while on study drug and 4 weeks after the last dose of study drug
Vomited in the 24 hours prior study drug administration (Cycle 1)
Treatment with molecularly targeted agents within the past 3 weeks prior to planned first study drug administration. Patients who were receiving standard chemotherapy or experimental therapies must wait 4 weeks from their last dose prior to the planned first study drug administration. Patients treated with nitrosoureas or mitomycin C must wait 6 weeks from their last dose prior to the planned first study drug administration.
Herbal supplements are prohibited 1 week prior to the planned first study drug administration, during the clinical study, and up to the time that the patient is discharged from the study
No concurrent radiotherapy or chemotherapy may be given to the patient during the administration of the study drug
Administration of an investigational study treatment within 30 days preceding the first dose of study treatment(s) in this study.
INTRATUMORAL DRUG DISTRIBUTION STUDY PATIENTS:
Patients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of: \r\n* 28 days from the administration of any investigational agent\r\n* 28 days from administration of prior cytotoxic therapy with the following exceptions: \r\n** 14 days from administration of vincristine\r\n** 42 days from administration of nitrosoureas\r\n** 21 days from administration of procarbazine\r\n* 7 days from administration of non-cytotoxic agents (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. [radiosensitizer does not count])\r\n* 28 days from prior radiation therapy
Patient is pregnant, breastfeeding, or expecting to conceive children while receiving study drug or for 180 days after the last dose of study drug.
Participants who have received any of the following within the listed time frame, prior to the first dose of study drug
Participants who have received the following within 7 days prior to the first dose of study drug:
For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration
Therapy with anticoagulant or antithrombotic agents (including aspirin) within 7 days prior to study drug administration
Patients may not be receiving any agents not approved by the Food and Drug Administration (FDA) within the past 4 weeks
Acute MI ? 3 months prior to dosing with study drug
Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
The first ASCI administration should be given within one year after the last chemotherapy administration. All screening procedures should be completed within seven weeks before the first ASCI administration.
Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
Anticoagulant drug therapy,
Subject must be receiving a stable dose of ASP8273 for 14 days minimum and is able to enroll into this rollover study without treatment interruption of study drug, or with no more than 21 consecutive days of treatment interruption in study drug within the parent study.
To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug; if the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners; donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug
Subject has received a prior EGFR inhibitor within 6 days prior to the first dose of study drug.
Subject has had any of the following within 14 days prior to the first dose of study drug:
Administration of any non-oncologic investigational drug within 30 days prior to receiving the first dose of topotecan/pazopanib
21 days from administration of procarbazine
Treatment with any Food and Drug Administration (FDA) non-approved study medication within the past four weeks; off label treatment with FDA approved medication is allowed
Patient is a woman with a positive urine or serum pregnancy test within 3 days prior to study drug administration, is breast-feeding, or is planning to conceive children within the projected duration of the study treatment
Patient who is participating in any investigational agent that is not Food and Drug Administration (FDA)-approved
Treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
The patient has been treated with radio- or toxin-immunoconjugates within 70 days of the first dose of the study drug
Patient who experienced any vomiting, retching, or nausea within 24 h prior to the administration of the study drug
Patient who received palonosetron within 1 week prior to administration of study drug.
Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 90 days after the last dose of study drug
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Prior treatment with Food and Drug Administration (FDA)-approved or investigational biologics or novel molecularly target therapies, including oral or IV formulations, are permitted; patients must be off prior targeted therapy for at least 14 days prior to study biopsy
Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours (h) after their final CEUS exam
HEALTHY VOLUNTEER: Participation in an investigational drug study within the period starting 1 month before study drug administration
Subjects will receive the standard Food and Drug Administration (FDA)-approved dose and schedule of 5-azacytidine; this dose is 75 mg/m^2 SC or intravenously (IV) daily for seven days with cycles repeated every 28 days
Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Surgical intervention within 28 days prior to the first dose of M3541 administration
Treatment with systemic chemotherapy or investigational therapy within 4 weeks of first study drug administration; other agents (e.g., biologics) within 2 weeks; radiation within 2 weeks; patients receiving 131I-MIBG therapy must wait 6 weeks prior to the initiation of study drug administration; corticosteroids (? 0.2 mg/kg/day prednisone or equivalent) or other immune suppressive drugs within the 2 weeks prior to the initiation of study drug administration.
Subject is suitable for oral administration of study drug.
Off study use of ketorolac or other NSAIDs prior to study administration within the perioperative window (7 days before surgery and up to the time of planned study administration)
Allergy/sensitivity to any study drug (degarelix, enzalutamide, trametinib, dasatinib), or drugs chemically related to study drug, or excipients or to dimethylsulfoxide
Patients must not be on enzalutamide within five half-lives before the first planned dose of the study drug or anticipating to start enzalutamide within the next 3 months of the first planned dose of study drug
CLL therapy, with the exception of ibrutinib within the following timeframes:\r\n* Chemotherapy, external beam radiation therapy, anticancer antibodies within 30 days prior to the first dose of drug on this study\r\n* Corticosteroid use >= 20 mg prednisone within 1 week prior to first dose on this study\r\n* Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose on this study\r\n* Allogeneic stem cell transplant within 6 months prior to first dose on this study
Prior exposure to a bromodomain inhibitor, such as OTX-015 or CPI-0610.
Able to tolerate CPI treatment regimen {if already starte
For the CPI-Treated Expansion Cohort: Subject must have received prior treatment with a CPI in the metastatic setting.
Prior exposure to a bromodomain inhibitor, such as OTX-015 or CPI-0610
Eligible to receive treatment with a CPI.
Received any prior treatment with a CPI.
No radiotherapy, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents or any anti-cancer therapy within the 2 weeks prior to treatment with CPI-613; hydroxyurea and oral tyrosine kinase inhibitors being used without grade =< 2 toxicity can be taken until day 1 of therapy; patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment); patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade 2 are eligible, but must be documented as such
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment (the use of Hydrea is allowed)
Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment
Therapy with CPI-613 prior to participating in this trial
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment; steroid use for management of refractory pain or for contrast induced allergy is allowed
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Patients who have received radiotherapy, surgery, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents, immunotherapy, or any other anti-cancer therapy of any kind, or any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of CPI-613 treatment
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment
Patients who have received immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Patients having received prior radiotherapy, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents or any anti-cancer therapy for a non-AML malignancy within the 2 weeks prior to treatment with CPI-613, or those who have not fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment)
Patients receiving any other standard or investigational treatment for their cancer with a primary goal of improving survival within the past 2 weeks prior to initiation of CPI-613 treatment
Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI-0610
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610
No radiotherapy, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents or any anti-cancer therapy within the 2 weeks prior to treatment with CPI-613; hydroxyurea and oral tyrosine kinase inhibitors being used without grade =< 2 toxicity can be taken until day 1 of therapy; patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment); patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade 2 are eligible, but must be documented as such
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment (the use of Hydrea is allowed)
Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment
Part C (CPI-Treated Expansion): Subject must have received prior treatment with a CPI in the metastatic setting
Inclusion Criteria:\n\n        Adults (aged ? 18 years)\n\n        Histologically confirmed diagnosis of a B-cell lymphoma that has progressed in spite of\n        prior treatment, and for which additional effective standard therapy is not available\n\n        Eastern Cooperative Oncology Group (ECOG) performance status ? 2\n\n        Adequate hematological, renal, hepatic, and coagulation laboratory assessments\n\n        Must give written informed consent to participate in this study before the performance of\n        any study-related procedure\n\n        Exclusion Criteria:\n\n        A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of\n        the CNS\n\n        Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the\n        absorption of CPI-1205, including any unresolved nausea, vomiting, or diarrhea that is\n        CTCAE grade >1\n\n        Treatment with proton pump inhibitors, H2 antagonists, or antacids\n\n        Achlorhydria, either documented or suspected on the basis of an associated disease (e.g.,\n        pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)\n\n        Impaired cardiac function or clinically significant cardiac diseases, including any of the\n        following:\n\n          -  Acute myocardial infarction or angina pectoris ? 6 months prior to starting study drug\n\n          -  New York Heart Association Class III or IV congestive heart failure\n\n          -  QTcF > 470 msec on the screening ECG\n\n        Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not\n        excluded)\n\n        A past medical history of other clinically significant cardiovascular disease (e.g.,\n        uncontrolled hypertension, history of labile hypertension or history of poor compliance\n        with an antihypertensive regimen)\n\n        Any other concurrent severe and/or uncontrolled concomitant medical condition that could\n        compromise participation in the study (e.g., clinically significant pulmonary disease,\n        clinically significant neurological disorder, active or uncontrolled infection)\n\n        Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of\n        CPI 1205\n\n        Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks\n        before the first dose of CPI-1205\n\n        Treatment with an investigational small molecule less than 2 weeks before the first dose of\n        CPI-1205.\n\n        Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-1205.\n\n        Treatment with medications that are strong inhibitors of CYP3A4\n\n        Treatment with medications that are inducers of CYP3A4 enzymes\n\n        Treatment with medications that are known to carry a risk of Torsades de Pointes\n\n        Pregnant or lactating women\n\n        Women of child bearing potential and men with reproductive potential, if they are unwilling\n        to use adequate contraception while on study therapy and for 3 months thereafter\n\n        Patients unwilling or unable to comply with this study protocol
Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI-0610
Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of CPI-0610
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610. In addition, the first dose of CPI-0610 should not occur before a period equal to or greater than 5 half-lives of the small molecule investigational agent has elapsed.
Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-0610. A minimum 2-week period between the last treatment with a therapeutic antibody and the first dose of CPI-0610 may be permitted in patients with rapidly progressive or aggressive subtypes of lymphoma following discussion with the medical monitor.
No acute toxicities from previous treatment higher than grade 1 at the start of treatment with CPI-613
Patients receiving any other standard or investigational treatment for their cancer, or any investigational agent for any non-cancer indication within the past 2 weeks prior to initiation of CPI-613 treatment
Treatment with any anti-cancer therapy within the 2 weeks prior to treatment with CPI-613
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 (6,8-bis[benzylthio]octanoic acid) treatment
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI-0610
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610. In addition, the first dose of CPI-0610 should not occur before a period equal to or greater than 5 half-lives of the small molecule investigational agent has elapsed
Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-0610. A minimum 2-week period between the last treatment with a therapeutic antibody and the first dose of CPI-0610 may be permitted in patients with rapidly progressive myeloma, following discussion with the medical monitor
Systemic anti-cancer treatment with a small molecule therapeutic (other than Ruxolitinib for the Combination arm) other than hydroxyurea less than 2 weeks before the first dose of CPI-0610
Administration of a therapeutic antibody less than 4 weeks before the first dose of CPI-0610. A minimum 2-week period between the last treatment with a therapeutic antibody and the first dose of CPI-0610 may be permitted in patients with rapidly progressive disease, following discussion with the medical monitor
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610. In addition, the first dose of CPI-0610 should not occur before a period equal to or greater than 5 half-lives of the small molecule investigational agent has elapsed
Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment
Patient is concurrently using other anti-cancer therapy.
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting study treatment with sonidegib
Patient is concurrently using other approved or investigational antineoplastic agent
Patient is concurrently using other approved or investigational antineoplastic agent
Concurrently using fibrin sealants or other anastomosis care devices
Patient is concurrently using other approved or investigational antineoplastic agent
Patient is concurrently using other approved or investigational antineoplastic agents
Patient is concurrently using other anti-cancer therapy.
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting LDE225
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy, or radiotherapy) concurrently or within 2 weeks of starting treatment
Patient who is concurrently using any other approved or investigational anti-neoplastic agent
Patient is concurrently using other approved or investigational antineoplastic agent
Patient is concurrently using other approved or investigational antineoplastic agents
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting treatment with LDE225
Use of any vaccines against infectious diseases (e.g. influenza, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Within 21 days of treatment initiation:\r\nPlatelets >= 100,000/mcL
The patients' last dose of chemotherapy must be at least 3 weeks prior to initiation of study therapy
Severe infection within 4 weeks prior to initiation of study treatment;
Severe infection within 4 weeks before initiation of study treatment
Within 14 days of treatment initiation:\r\nPlatelets >= 100,000/mcL
Treatment with investigational therapy within 30 days prior to initiation of study treatment
Patients who have had chemotherapy (e.g., purine analogues, alkylating agents), radiation therapy, or participation in any investigational drug treatment within 4 weeks of initiation of DMF or at any time during the study
No prior lapatinib within 7 days prior to initiation of protocol treatment
Treatment with investigational therapy within 14 days prior to initiation of study treatment
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Had immunotherapy, radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4 weeks prior to treatment initiation (or oral therapy within 1 week prior to treatment initiation).
Non-escalating steroid requirement at the time of consent and study drug initiation for the treatment of CNS symptoms
Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
Severe infection within 4 weeks prior to initiation of study treatment
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Participant is able to complete a minimum of 14 days of study agent dosing prior to initiation of definitive treatment for their cancer
Use of any vaccines against infectious diseases within 4 weeks of initiation of study treatment.
Investigational therapy within 28 days prior to initiation of study treatment
Between days 28 and 50 post transplantation at the time of initiation of the study drug
Patients must be off all disease modifying therapy for MDS for 28 days prior to initiation of study treatment; patients may receive hydrocortisone prophylactically to prevent transfusion reactions
Performed within 10 business days of treatment initiation with the exception of beta- HCG (72 hours), if applicable: Platelets >= 75,000 / uL.
Patients who are receiving any other investigational agents. A minimum washout period of 28 days is required prior to the initiation of on study treatment.
Patients with microscopic hematuria (defined as > 100 red blood cells [RBCs] on urinalysis) or worsening urinary symptoms within 7 days prior to the initiation of study treatment.
Any prior PSA, MUC1, and/or brachyury-targeted immunotherapy (e.g., vaccine) must have been discontinued at least 12 weeks before initiation of study treatment; subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to initiation of therapy. The use of live vaccines within 30 days before initiation of therapy. IMiDs, PIs and or corticosteroids within 2 weeks prior to initiation of therapy. Other investigational therapies and monoclonal antibodies (mAb) within 4 weeks of initiation of therapy Prednisone up to but no more than 10 mg orally once daily (q.d.) or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to initiation of therapy
Treatment with any of the drugs listed in Section 8.4.5 at the time of study treatment initiation.
Severe infection within 4 weeks prior to initiation of study treatment
Indication for initiation of therapy
Herbal preparations are not allowed throughout the study, and should be discontinued 14 days prior to initiation of study treatment
Patients may not be taking any corticosteroid for any reason while on study and all corticosteroids must be stopped two weeks prior to initiation of study drug
Previous anticancer treatment must be discontinued at least 3 weeks prior to the initiation of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, except 8 weeks for bicalutamide);
Have received any unapproved agent or device within 30 days before initiation of study treatment.
All patients must discontinue anti-platelet agents or anticoagulants 7 days prior to initiation of study drug
Have received treatment with any form of therapy with CYP17 inhibitory activity such as ketoconazole, aminoglutethimide, or an antiandrogen such as bicalutamide within 6 months of study treatment initiation
Current or previous treatment with investigational therapy in another therapeutic clinical trial interrupted less than 4 weeks before study treatment initiation.
Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Patient received investigational treatment within 2 weeks or immunotherapy or antibody therapy within 28 days prior to initiation of treatment with Toca 511, and/or has not recovered from toxicities associated with such treatment.
Surgery prior to enrollment within 28 days prior to the initiation of study treatment or unhealed surgical incision;
Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study).
Prior chemotherapy treatment for AML within 21 days from the initiation of HCT conditioning; Note, use of hydroxyurea or other low intensity treatment not intended to induce remission are acceptable
Participants in the study must permit targeted prostate biopsy prior to initiation of study treatment and at the time of fiducial marker placement
Patients must have stable topical medication regimen for 2 weeks prior to study initiation
History of treatment with canakinumab within the 12 months prior to study initiation
History of phototherapy within 2 weeks prior to study initiation
Radiotherapy within 21 days prior to initiation of study treatment
Loco-regional treatment within 4 weeks prior to initiation of study treatment.
The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.
Any anti-lymphoma treatment within 6 months of treatment initiation.
Last chemotherapy at least 3 weeks from initiation of study treatment
Have received any unapproved agent or device within 30 days before initiation of study treatment.
Received the following within 7 days prior to the initiation of study treatment:
Treatment with investigational therapy within 14 days prior to initiation of study drug
Investigational therapy within 28 days prior to initiation of study treatment
Prior recent systemic or investigational therapy within 21 days of initiation of study treatment; an exception is that EGFR inhibitor may be continued up until 3 days of initiation of study treatment
Systemic strontium-89, samarium-153, rhenium-186, or rhenium-188 for bone metastases within 24 weeks prior to initiation of study treatment
Subjects who have completed sipuleucel-T (Provenge ®) treatment within 28 days of study drug initiation.
Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval
Participant treated with any prior systemic therapy with the exception of the following:\r\n* Treatment by localized radiotherapy for a specific indication within 2 weeks of initiation of treatment\r\n* Treatment with corticosteroids, not to exceed the equivalent of 160 mg of dexamethasone over a four-week period before initiation of protocol therapy
Patients who have received chemotherapy within 3 weeks prior to the initiation of study treatment, or endocrine therapy within 2 weeks prior to the initiation of study treatment; if patients are already on trastuzumab, this medication may be continued
Patients who have participated in a prior investigational study within 3 weeks prior to initiation of study treatment
Severe infection within 4 weeks prior to initiation of study treatment
Treatment with chemotherapy (other than high-dose chemotherapy as described above) or differentiation therapy (such as retinoic acid) or immunotherapy (such as anti-GD2 antibody treatment) within 3 weeks prior to initiation of study drug or, if treatment included nitrosoureas, within 6 weeks prior to initiation of study drug
Treatment with thoracic or mediastinal radiotherapy within 3 weeks prior to initiation of study drug
Treatment with investigational therapy (with the exception of cancer therapies as described above) within 4 weeks prior to initiation of study drug
Treatment with herbal cancer therapy within 1 week prior to initiation of study drug
Serum bilirubin 1.5 x ULN, obtained within 14 days prior to initiation of study treatment
Serum creatinine =< 1.5 x ULN, obtained within 14 days prior to initiation of study treatment
Treatment for the studied cancer within 28 days prior to initiation of study treatment
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Use of any vaccines against infectious diseases (e.g., influenza, varicella, etc.) within 4 weeks (28 days) of initiation of study therapy and 60 days after the last administration of the study medication.
Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
Any investigation agents must be discontinued at least 30 days prior to study treatment initiation
The baseline brain MRI/CT must be performed less than 15 days prior to initiation of study treatment; otherwise it must be repeated
A brain MRI/CT must be performed less than 15 days prior to initiation of study treatment; otherwise it must be repeated
Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
Subjects must be off any steroids 7 days prior to the initiation of treatment
Subjects must be off any curcumin, tumeric, or vitamin D supplements for 14 days prior to the initiation of treatment
Positive culture for or other clinical evidence of infection with bacteria or fungus within 14 days of the initiation of study treatment
Subjects must not have received other antineoplastic agents with therapeutic intent, excluding hydroxyurea and antimetabolites administered as part of maintenance chemotherapy, within 7 days prior to study treatment initiation
Patients who have received chemotherapy or radiotherapy within 4 weeks prior to enrollment are NOT eligible for participation \r\n* The exception to this is patients who are refractory to conventional initial induction chemotherapy (=< 2 courses) or to radiation; patients must have morphologic proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of AML with > 10% blasts within 2 weeks prior to initiation of study therapy\r\n* The last dose of cytotoxic therapy (NOT including Hydrea, which is allowed) must have been given >= 14 days prior to initiation of study therapy\r\n* The last dose of biologic therapy must have been given >= 7 days prior to initiation of study therapy\r\n* The last dose of any investigational agent must have been given >= 14 days prior to initiation of study therapy
Prior therapy with strontium-89, samarium, rhenium-186 etidronate, chemotherapy or androgen biosynthesis inhibitors for prostate cancer is not allowed. Previous immunologic, homeopathic, natural, or alternative medicine therapies are acceptable provided treatment ended greater than 28 days prior to initiation of study drug
Within 8 weeks of treatment initiation (day 0), have received treatment with:\r\n* Imiquimod\r\n* Total body electron beam radiation\r\n* Investigational drugs or treatments
Subjects must be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroids for ?10 days prior to initiation of study treatment
Received >24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drug
Receiving any other therapies for cancer treatment (with the exception of gonadotropin-releasing hormone [GnRH] agonists for prostate cancer); Note: hydroxyurea is allowed before initiation of study treatment and for the first 5 days of study treatment
History of receiving any investigational treatment within 28 days of study medication initiation
Initiation of anti-tumor therapy including chemotherapy or investigational drug treatment within 30 days before beginning study
Patients must not have the following foods/ supplements at least 7 days prior to initiation of and during study treatment:
Initiation of a new drug therapy within the past 30 days prior to study commencement
Has, at the planned initiation of study drug, an uncontrolled infection.
All pre-treatment laboratory tests and scans must be performed within 14 days prior to initiation of treatment
Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
Planned initiation, termination, or dose alteration of hydroxyurea during the study
Bilirubin =< 1.5 x ULN, within 14 days prior to initiation of study drug
Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation
Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment will not be excluded)
Concomitant medication as follows:\r\n* Subjects treated with gabapentin or other anticonvulsant for neuropathic pain will be required to taper the medication and discontinue for at least 2 weeks prior to study initiation\r\n* Patients on antidepressant treatment for pain or depression (tricyclic antidepressants [TCAs], selective serotonin reuptake inhibitor [SSRI], serotonin–norepinephrine reuptake inhibitors [SNRIs] etc.) will be allowed to continue their medications provided they have been on a stable dose for at least 4 weeks before study initiation; no dose regimen changes of antidepressants will be allowed during the study period\r\n* Patients on around-the clock opioid treatment (including tramadol) will be allowed to continue their medication provided they have been on a stable dose for at least 4 weeks before study initiation; the maximum allowed dose of opioid will be equivalent to 60 mg oral morphine sulfate; patients with higher doses will be required to taper down their opioid dose to maximum 60mg oral morphine equivalent, and continue on stable dose for 4 weeks before enrollment in the study; pro re nata (PRN) short-acting opioids for painful CIPN treatment will not be allowed; patients receiving PRN short-acting opioids (with or without acetaminophen) for pain other than CIPN will be allowed up to 4 daily doses, with daily recording of analgesic consumption\r\n* Treatment with nonsteroidal anti-inflammatory drug (NSAIDs) will be discontinued at least 2 weeks before study initiation; however, low-dose aspirin (=< 325 mg/day) will be allowed
Patient participants must be at a point of treatment initiation/change or evaluation for treatment initiation/change
Within the first 3 weeks of initiation of a new type of therapy
Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Initiation of investigational agent =< 3 days after initiation of radiotherapy
Initiation of hormone therapy < 4 weeks prior to enrollment in the study
Use of any systemic antifungal therapy for > 72 hours during the week prior to study drug initiation
Willing to repeat RPFNA at 12 months following initiation of study agent
All visible papillary lesions must be macroscopically resected within 60 days of treatment initiation
Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1
Had at least 14 days for prior treatment to clear the body before initiation of DS-3201b administration (except for hydroxyurea that needs only 2 days for clearance)
Discontinuation of all other therapies (including radiotherapy or chemotherapy) for the treatment of iNHL >= 3 weeks before initiation of study treatment
Have discontinued all disease-modifying therapy for the primary cancer >28 days prior to initiation of study treatment. In addition, clinically significant toxicities associated with any prior therapy for the primary cancer, including investigational treatments, have resolved or stabilized to Grade ?1 toxicity >28 days prior to initiation of study treatment with the exception of neuropathy, which must have resolved to Grade ?2. Continuation of a stable dose (minimum of 28 days prior to study entry) of denosumab or bisphosphonate is permitted on study.
Have discontinued all disease-modifying therapy for the primary cancer for 28 days prior to initiation of study treatment.
Baseline (prior to the initiation of new ET), and;
Subsequently at 1, 2, 3 and 12 months after the initiation of therapy, and/or;
Pregnant or actively breastfeeding without intention to discontinue prior to initiation of study
Receipt of any investigational therapy is not permitted within 28 days prior to the first dose of nivolumab
Receipt of drugs with laxative properties and herbal or natural remedies for constipation within 90 days of receiving MEDI4736 or MEDI + tremelimumab
Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
Prior randomization or treatment in a previous MEDI4736 and/or tremelimumab clinical study regardless of treatment arm assignment or receipt of any investigational anticancer therapy within 28 days or 5 half-lives
Use of systemic steroids within 7 days before the first dose of MEDI-551 (inhaled and topical corticosteroids are permitted). Subjects may take replacement doses of steroids (defined as ? 30 mg/day hydrocortisone or the equivalent) if on a stable dose for at least 2 weeks prior to the first dose of MEDI-551. This does not include required steroid prophylaxis prior to the first infusion of MEDI-551
Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276.
Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276.
Hemoglobin ³ 9.0 g/dL within first 2 weeks prior to first dose of MEDI0680 (AMP-514)
Receipt of any BRAF inhibitor (in metastatic melanoma), or investigational anticancer therapy within 4 weeks prior to the first dose of MEDI0680 (AMP-514)
Receipt of any investigational anticancer therapy within 4 weeks prior to the first dose of MEDI0639 or in the case of monoclonal antibodies, 6 weeks prior to the first dose of MEDI0639
Receipt of any investigational anticancer therapy within 30 days prior to the first dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days prior to the first dose of MEDI3617
No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration; for GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment
No treatment with immunotherapy =< 21 days before re-registration; no treatment with biologic therapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before re-registration; no treatment with nitrosourea or mitomycin =< 42 days before re-registration
No treatment with biological therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration
No investigational agent within 21 days prior to registration
No investigational therapy within 14 days prior to registration
Patients must not have any anticancer therapy or investigational agent within 28 days prior to step 1 registration
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
Other investigational treatment during or within 30 days before starting study registration
Treatment with any therapeutic investigational agent within 28 days prior to study registration.
Patients must not have received treatment with any chemotherapy, immunotherapy, radiotherapy or an investigational agent for malignancy within the 28 days preceding study registration; patients may not have received treatment with nitrosoureas or mitomycin within the 42 days prior to study registration; patients may not have received treatment with a small molecule targeted agent (including off-label or investigational use) within 14 days preceding study registration, provided this represents at least 7 half-lives for that agent; toxic effects from any prior therapy (except alopecia) must have resolved to grade 1 or less according to National Cancer Institute (NCI) CTCAE version (v)4.0 or to the patient’s baseline by the time of registration
Treatment with any investigational agent or approved therapy within 28 days
Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy
Patients who have received any other investigational agent =< 28 days prior to registration are not eligible
No treatment with any investigational agent within 30 days prior to being registered for protocol therapy
No treatment with any investigational agent within 30 days prior to registration for protocol therapy
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration
Treatment with any investigational agent within 30 days prior to registration for protocol therapy
Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
Prior treatment with any other agent that may affect M-protein =< 30 days prior to registration
Use of an investigational agent within the previous 28 days of study registration
Anti-cancer therapy or any treatment with an investigational agent within 30 days prior to randomization
Treatment with any other investigational agent within 28 days prior to registration. Subjects must not be treated with any other investigational agent while on protocol specified therapy.
No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
Investigational agent within 21 days prior to day 1 of protocol therapy
Received an investigational agent within 30 days prior to registration
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
Subjects must have received their last dose of investigational or biologic agent >= 7 days prior to study registration\r\n* In the event that a subject has received an investigational or biologic agent and has experienced >= grade 2 myelosuppression, then at least three (3) weeks must have elapsed prior to registration\r\n* If the investigational or biologic agent has a prolonged half-life (>= 7 days) then at least three (3) weeks must have elapsed prior to registration
No treatment with any investigational agent within 30 days prior to study registration.
Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
Treatment with any investigational agent within 28 days prior to registration.
Any investigational agent is acceptable if administered >= 30 days before registration
Received treatment with radiation therapy or investigational therapy =< 28 days prior to registration
No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline.
Systemic therapy or investigational agent administered < 28 days prior to treatment with nintedanib
Treatment with any investigational agent within 30 days prior to registration for protocol therapy
Administration of any investigational agent =< 30 days prior to pre-registration
Use of any investigational product within 4 weeks prior to randomization
Patients whose apheresis product were to be further selected and purified
Active, known, clinically serious infections within the 14 days prior to first dose of investigational product
Prior history of anaphylaxis with this product type
Agree to use condoms until 30 days following the last dose of investigational product, or
Subject has received treatment with any investigational immunotherapy within 2 years prior to study screening or has received treatment with any other investigational product within 28 days prior to study screening
Subject who has been treated with an investigational product and has not completed the entire follow-up period for that investigational product;
Treatment with any investigational product within 28 days prior to Screening.
Radiation therapy within 4 weeks of investigational product.
Cytotoxic chemotherapy within 4 weeks of investigational product (6 weeks for mitomycin C or nitrosoureas) if immediate prior regimen was administered on an every 3 4 week schedule or 2 weeks of investigational product if immediate prior regimen consisted of weekly therapy.
Any other anti cancer agents (eg, hormonal, biological, investigational) within 5 times the half life prior to investigational product.
Subjects who have participated in a clinical trial within 30 days of Screening or are scheduled to receive an investigational product.
Previous investigational product (IP) assignment in the present study
Administration of another investigational medicinal product within 30 days before the screening period.
Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational medicinal product (IMP) within ? 5 x the half-life of the IMP prior to day 1 cycle 1 of Minnelide.
Have received or are receiving an investigational medicinal product (IMP) or other systemic anticancer treatment within 2 weeks prior to the first dose of study treatment
Participating in any other clinical trials using an investigational product.
Treatment with any small molecule investigational medicinal product (IMP) within 28 days prior to first dose
investigational product AGS-16C3F and/or,
Known allergy or hypersensitivity to investigational product (IP) or any excipient
Patients who are currently participating in any other clinical trial of an investigational product
Hemoglobin >= 8.0 g/dL within first 2 weeks prior to first dose of investigational product
Patients who are currently participating in any other clinical trial of an investigational product
The subject must have no measurable disease at the time of investigational product administration\r\n* The subject must complete all prior surgery requiring general anesthesia at least four (4) weeks before administration of the investigational product; the subject must complete all surgery requiring local/epidural anesthesia at least seventy-two (72) hours prior to administration of the investigational product\r\n* The subject must complete all prior systemic chemotherapy therapy, and all adverse events have either returned to baseline or have stabilized at least four (4) weeks prior to administration of the investigational product\r\n* The subject must complete all prior systemic radiation therapy at least four (4) weeks prior to administration of the investigational product; the subject must complete all prior focal radiation therapy at least two (2) weeks prior to the administration of the investigational agent; the subject must not have received a radiopharmaceutical within eight (8) weeks prior to the administration of the investigational product\r\n* The subject may continue hormonal therapy (i.e. tamoxifen, anastrozole) during the study
The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product
Treatment with an investigational product during the last 2 weeks
Requiring blood product support
Receipt of radiation therapy within 4 weeks prior to starting investigational product, or limited field of radiation for palliation within 2 weeks of the first dose of investigational product
Requiring blood product support
Intolerance to the investigational product or its excipients, or any condition that would significantly impair and/or prohibit the patient's participation in the study, as per the Investigator's judgment.
Current or recent treatment with any other investigational medicinal product or device
Received an investigational product or been treated with an investigational device within 30 days prior to first drug administration, or plans to start any other investigational product or device study within 30 days after last drug administration.
Use of any investigational product within 4 weeks prior to randomization
Has received a T-cell product within 6 weeks prior to planned infusion of genetically modified T cells.
Requiring blood product support
Requiring ongoing blood product support at time of pre-registration
Requiring blood product support
Research product must pass all release tests
Use of any investigational product within 30 days prior to randomization
Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
Investigational medicinal product within the last 30 days prior to screening
Investigational medicinal product within the last 30 days prior to screening
Treatment with any investigational product within < 4 half-lives for each individual investigational product OR 28 days prior to randomization
Patient has an investigational medicinal product within the last 30 days prior to screening.
Male subjects must refrain from donating sperm starting at the planned first dose of investigational product (IP) until 30 days following the last dose of IP
Had chemotherapy or radiotherapy within 4 weeks prior to the first day of Investigational Product (IP) administration.
Participation in a therapeutic investigational study within 4 weeks prior to enrollment, or anticipated treatment with another investigational product while on study; this refers to non-commercially approved investigational drugs different than those used in this protocol
Patients on immunosuppressants, systemic corticosteroids, or any other investigational product.
Known allergy or hypersensitivity to Investigational Product.
Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.
Use of any investigational product or investigational medical device within 28 days prior to enrollment
Patient who will be receiving another investigational product during the study
No treatment with an investigational product or device within 21 days of cycle 1 day 1
The patient has received therapeutic dose chemotherapy or radiotherapy ? 21 days prior to start of Investigational Product.
The patient has received maintenance dose chemotherapy (e.g., low dose cyclophosphamide) ? 7 days from the first dose of Investigational Product.
The patient has received any investigational therapy ? 28 days prior to start of Investigational Product. Investigational therapy is defined as any medicinal product that is not approved in the country of treatment for any indication, adult or pediatric.
The patient has received any biological therapy ? 7 days prior to the start of Investigational Product, or monoclonal antibody ? 3 half-lives or 28 days, whichever is shorter, prior to the first dose of Investigational Product.
Concurrent use of any other investigational product
Treatment with an investigational product or device within 21 days of cycle 1 day 1
Patients who have received another investigational product within the longer of 14 days or 5 half-lives of the previous product
DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with G-CSF or cryopreserved unmodified leukapheresis product from the original donor can be used; if cryopreserved product is not available, the following criteria apply for the DLI product:
Exposure to an investigational product or investigational device in another clinical study within 4 weeks prior to C1D1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study
Understand that the (investigational Product) IP could have a potential teratogenic risk.
Prior treatment with any investigational product within the past 4 weeks
All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study
Subjects receiving any other investigational medicinal product or anti-cancer therapy.
The subject has received an investigational product within the following time period prior to the first dosing day in the current study: 28 days or 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is warranted by the data).
Received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration
The patient has received any investigational or non-registered medicinal product other than the study treat-ment within 30 days preceding the first dose of study treatment or plans to receive such a drug during the study period.
The patient has received any investigational or non-registered medicinal product other than the study medi-cation within 30 days preceding the first dose of study medication or plans to receive such a drug during the study period.
Other investigational product-concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Other medications that might interfere with the evaluation of the investigational product
Other investigational product — concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Other medications that might interfere with the evaluation of the investigational product
Known or suspected hypersensitivity to any of the constituents of the investigational product
Subjects must be willing to undergo a cystoscopy on study for investigational product removal.
Subjects who have received radiotherapy to the pelvis and/or sternum within one year of first Investigational Product administration
Subjects who have had a venous or arterial embolic event AND who have received anti-coagulant treatment, where both the event and the treatment were within six months of the first Investigational Product administration
Subjects who have received treatment with an investigational agent within 30 days of the projected first administration of Investigational Product (Day 0)
Less than 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
RECIPIENT: Other investigational product – concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
RECIPIENT: Other medications that might interfere with the evaluation of the investigational product
Administration of any blood product within 3 months of enrollment
Participation in a trial of an investigational medicinal product within the previous 28 days
Known clinically-significant doubling in marrow or perIP (INVESTIGATIONAL PRODUCT) heral blood blast percentage (to ? 20%) in the 8-week period leading to the first dose of IP (INVESTIGATIONAL PRODUCT) (Cycle 1, Day 1)
Use of any of the following within 28 days prior to the first dose of IP (INVESTIGATIONAL PRODUCT):
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study, in which no investigational product will be administered. Subjects will be invited to the gynaecological follow-up study if either of the following applies:
Subject has previously received VM110, or any other investigational product in the past thirty days
TOBACCO PRODUCT USERS
testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration
Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments
Agrees not to receive any other investigational product or therapy while participating in this study.
Has received an investigational product within the 30 days prior to Lymphoseek administration
Patients with the use of any investigational product or device, excluding fluorodopa (F-DOPA) scans, within 30 days prior to dosing
May have received treatment with an investigational product.
Treatment with any investigational product within 30 days before the first infusion.