{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 3 Anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 3 Duodenal hemorrhage"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 3 Adrenal insufficiency"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 3 General disorders & administration site conditions - Mucosal bleeding, lower GI hemorrhage"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"description":"Safety of the combination of (1) CV301, (2) N-803 (Anktiva), (3) M7824 (MSB0011359C) and (4) NHS-IL12 (M9241) in participants with advanced small bowel and colorectal cancers was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.","groups":[{"description":"Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + (NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12.\n\nCV301: 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.\n\nMSB0011359C: 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\nN-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.\n\nNHS-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":"OG000","title":"Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation"},{"description":"Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12.\n\nCV301: 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.\n\nMSB0011359C: 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\nN-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.\n\nNHS-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) DL2, Quad Therapy Dose Escalation"},{"description":"Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); fixed dose of NHS-IL12.\n\nCV301: 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.\n\nMSB0011359C: 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\nN-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.\n\nNHS-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 2b Dose Level (DL)2, Quad Therapy Fixed Dose"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 27 months for Cohort 2, Arm 2a Dose Level 1; 18 months and 29 days for cohort 2, Arm 2a Dose Level 2; and 7 months and 20 days for Cohort 2, Arm 2b, Dose Level 2.","title":"Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Quadruple Therapy","type":"SECONDARY","unitOfMeasure":"Participants"}