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NCT04491955 · ADVERSE EVENTS

Adverse events

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers · Source last updated 2025-04-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1; 27 months for Cohort 2, Arm 2a Dose Level (DL) 1; 18 months and 29 days for cohort 2, Arm 2a DL 2; and 7 months and 20 days for Cohort 2, Arm 2b, DL 2.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)

Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + (M7824 (MSB0011359C) + N-803 (Anktiva) (Triple Therapy). CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B.

2 / 1212 / 129 / 12
Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation

Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + (NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D1) and D15. Starting on D29, FPV-CV301 (1 x 10\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.

4 / 88 / 85 / 8
Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation

Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and FPV-CV301. MVA-BN-CV301 (4 x 10\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.

1 / 66 / 64 / 6
Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose

Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); fixed dose of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.

0 / 66 / 63 / 6

Group identifiers: EG000: Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) · EG001: Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation · EG002: Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation · EG003: Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac troponin I increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Duodenal hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Edema limbs
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Mucosal bleeding, Lower Gastrointestinal Hemorrhage
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    General disorders and administration site conditions - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sepsis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      8
      num Events
      19
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Arthritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bladder infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Blood bilirubin increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac troponin I increased
Complete source fields
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    12
    description
    Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + (M7824 (MSB0011359C) + N-803 (Anktiva) (Triple Therapy). CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    2
    serious Num At Risk
    12
    title
    Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)
  2. deaths Num Affected
    5
    deaths Num At Risk
    8
    description
    Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + (NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D1) and D15. Starting on D29, FPV-CV301 (1 x 10\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    4
    serious Num At Risk
    8
    title
    Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation
  3. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and FPV-CV301. MVA-BN-CV301 (4 x 10\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation
  4. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); fixed dose of NHS-IL12. CV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year. MSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter. N-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B. NHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      8
      num Events
      19
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Arthritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bladder infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Blood bilirubin increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac troponin I increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac troponin I increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Duodenal hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Edema limbs
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Mucosal bleeding, Lower Gastrointestinal Hemorrhage
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    General disorders and administration site conditions - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sepsis
time Frame
Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1; 27 months for Cohort 2, Arm 2a Dose Level (DL) 1; 18 months and 29 days for cohort 2, Arm 2a DL 2; and 7 months and 20 days for Cohort 2, Arm 2b, DL 2.

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