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NCT04491955 · OUTCOME

Overall Survival (OS)

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.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 35 months

What was measured

OS per treatment assignment (three or four drug combination) evaluated using Kaplan-Meier methods. OS is defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive.

Groups in this outcome

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.

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.

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)12
Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation8
Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation6
Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose6

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)19Not reported12NAThe confidence intervals are calculated using the Brookmeyer-Crowley method; if the upper limit of the interval does not intersect the median then it is not able to be estimated.
Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation19Not reported15NAThe confidence intervals are calculated using the Brookmeyer-Crowley method; if the upper limit of the interval does not intersect the median then it is not able to be estimated.
Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation4.5Not reported4.5NAThe confidence intervals are calculated using the Brookmeyer-Crowley method; if the upper limit of the interval does not intersect the median then it is not able to be estimated.
Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose7.0Not reported4.9NAThe confidence intervals are calculated using the Brookmeyer-Crowley method; if the upper limit of the interval does not intersect the median then it is not able to be estimated.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The confidence intervals are calculated using the Brookmeyer-Crowley method; if the upper limit of the interval does not intersect the median then it is not able to be estimated.
        group Id
        OG000
        lower Limit
        12
        upper Limit
        NA
        value
        19
      2. comment
        The confidence intervals are calculated using the Brookmeyer-Crowley method; if the upper limit of the interval does not intersect the median then it is not able to be estimated.
        group Id
        OG001
        lower Limit
        15
        upper Limit
        NA
        value
        19
      3. comment
        The confidence intervals are calculated using the Brookmeyer-Crowley method; if the upper limit of the interval does not intersect the median then it is not able to be estimated.
        group Id
        OG002
        lower Limit
        4.5
        upper Limit
        NA
        value
        4.5
      4. comment
        The confidence intervals are calculated using the Brookmeyer-Crowley method; if the upper limit of the interval does not intersect the median then it is not able to be estimated.
        group Id
        OG003
        lower Limit
        4.9
        upper Limit
        NA
        value
        7.0
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    units
    Participants
description
OS per treatment assignment (three or four drug combination) evaluated using Kaplan-Meier methods. OS is defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)
  2. 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
    OG001
    title
    Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation
  3. 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
    OG002
    title
    Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation
  4. 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
    OG003
    title
    Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 35 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice