Trial · NCT04491955
Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers
NCT04491955, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers. Trials, record NCT04491955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04491955
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers
- NCT number
- NCT04491955
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Small Bowel Cancers, Colorectal Cancers
- Interventions
- CV301, MSB0011359C, N-803, NHS-IL12
- First posted
- 2020-07-30
- Last updated
- 2025-04-24
- Results first posted
- 2023-11-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) for Triple Therapy | one year | ORR of the combination of (1) Carcinoembryonic antigen (CEA)/Mucin-1 (MUC1) vaccines, (2) N-803 (Anktiva) and (3) M7824 (MSB0011359C) in participants with advanced small bowel and colorectal cancers was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Objective response is a complete or partial radiographic response as defined by RECIST 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| Primary | Objective Response Rate (ORR) for Quadruple Therapy | one year | ORR of the combination of (1) Carcinoembryonic antigen (CEA)/Mucin-1 (MUC1) vaccines, (2) N-803 (Anktiva), (3) M7824 (MSB0011359C) and (4) NHS-IL12 (M9241) in participants with advanced small bowel and colorectal cancers was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Objective response is a complete or partial radiographic response as defined by RECIST 1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Triple Therapy | Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1. | Safety of the combination of (1) CV301, (2) N-803 (Anktiva) and (3) M7824 (MSB0011359C) 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. |
| Secondary | Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Quadruple Therapy | 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. | 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. |
| Secondary | Progression Free Survival (PFS) | From time to enrollment up to 35 months | PFS per treatment assignment (three or four drug combination was evaluated using Kaplan-Meier methods and is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Participants who do not have disease progression or have not died at the end of follow up will be censored at the last known date the participant was progression free. Progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
| Secondary | Overall Survival (OS) | Up to 35 months | 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. |
| Secondary | Duration of Response (DOR) | Up to 34 months | DOR per treatment assignment (three or four drug combination) is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Number of Participants Hospitalized Due to Serious Adverse Events Attributed to Progressive Disease (PD) | time participant is first enrolled to time participant is taken off of study treatment, an average of 2.1 months. | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. And progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 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. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) for Triple Therapy | one year | Proportion of participants | NUMBER | |
| PRIMARY | Objective Response Rate (ORR) for Quadruple Therapy | one year | Percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Triple Therapy | Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Quadruple Therapy | 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. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (PFS) | From time to enrollment up to 35 months | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to 35 months | Months | MEDIAN | |
| SECONDARY | Duration of Response (DOR) | Up to 34 months | 1/32 participants were evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Number of Participants Hospitalized Due to Serious Adverse Events Attributed to Progressive Disease (PD) | time participant is first enrolled to time participant is taken off of study treatment, an average of 2.1 months. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) for Triple Therapy | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | Complete Response | 0 | Proportion of participants | |
| Objective Response Rate (ORR) for Triple Therapy | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | Partial Response | 0 | Proportion of participants | |
| Objective Response Rate (ORR) for Quadruple Therapy | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | Complete Response | 12.5 | Percentage of participants | |
| Objective Response Rate (ORR) for Quadruple Therapy | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | Complete Response | 0 | Percentage of participants | |
| Objective Response Rate (ORR) for Quadruple Therapy | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | Complete Response | 0 | Percentage of participants | |
| Objective Response Rate (ORR) for Quadruple Therapy | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | Partial Response | 0 | Percentage of participants | |
| Objective Response Rate (ORR) for Quadruple Therapy | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | Partial Response | 0 | Percentage of participants | |
| Objective Response Rate (ORR) for Quadruple Therapy | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | Partial Response | 0 | Percentage of participants | |
| Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Triple Therapy | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | Grade 3 Alkaline phosphatase increased | 1 | Participants | |
| Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Triple Therapy | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | Grade 3 Anemia | 1 | Participants |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 12 | |
| Overall Study | STARTED | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 8 | |
| Overall Study | STARTED | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | 6 | |
| Overall Study | STARTED | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | 6 | |
| Overall Study | COMPLETED | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 12 | |
| Overall Study | COMPLETED | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 8 | |
| Overall Study | COMPLETED | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | 6 | |
| Overall Study | COMPLETED | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | 6 | |
| Overall Study | NOT COMPLETED | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events448
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 5 | 12 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 1 | 8 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | 3 | 6 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | 1 | 6 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 1 | 12 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 0 | 8 | 0 |
| other | Adrenal insufficiency | Endocrine disorders | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | 0 | 6 | 0 |
| other | Adrenal insufficiency | Endocrine disorders | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | 0 | 6 | 0 |
| other | Alanine aminotransferase increased | Investigations | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 4 | 12 | 5 |
| other | Alanine aminotransferase increased | Investigations | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 2 | 8 | 3 |
1 to 10 of 448Source ClinicalTrials.gov
See all 448 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 9 | 12 |
| Total, all-cause mortality | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 5 | 8 |
| Total, all-cause mortality | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | 4 | 6 |
| Total, all-cause mortality | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | 3 | 6 |
| Total, other adverse events | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 12 | 12 |
| Total, other adverse events | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 8 | 8 |
| Total, other adverse events | Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation | 6 | 6 |
| Total, other adverse events | Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose | 6 | 6 |
| Total, serious adverse events | Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241) | 2 | 12 |
| Total, serious adverse events | Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation | 4 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41520164 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04491955
GET https://conductscience.org/api/trials/v1/NCT04491955/results?page=2