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.