Trial Outcomes & Findings for Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors (NCT NCT03693846)
NCT ID: NCT03693846
Last Updated: 2022-10-20
Results Overview
To determine six-month progression-free survival by iRECIST from start of study treatment until 6 months
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Start of treatment until 6 months later
Results posted on
2022-10-20
Participant Flow
Eleven subjects were consented/enrolled and active on study treatment for at least one cycle.
Participant milestones
| Measure |
Nivolumab and Ipilimumab
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
Baseline characteristics by cohort
| Measure |
Nivolumab and Ipilimumab
n=11 Participants
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Start of treatment until 6 months laterTo determine six-month progression-free survival by iRECIST from start of study treatment until 6 months
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=11 Participants
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Number of Participants With Progression-Free Survival at 6 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: start of treatment until disease progression or death, assessed up to 2 yearsto determine Progression-Free survival from start of study treatment until time of documented disease progression or death assessed up to 2 years
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=11 Participants
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Progression-Free Survival
|
1.91 months
Interval 0.72 to 2.99
|
SECONDARY outcome
Timeframe: From start of treatment until death assessed up to 2 yearsOverall survival (OS) is defined as the duration of time from start of treatment to death
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=11 Participants
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Overall Survival
|
3.45 Months
Interval 1.61 to 4.04
|
SECONDARY outcome
Timeframe: From start of treatment until progression or death assessed up to 2 yearsThe objective response rate is determined by the percentage of individuals on study attaining a complete or partial response as noted by by iRECIST and RECIST v1.1 Criteria
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=11 Participants
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Objective Response Rate
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From the first recorded partial or complete response until progressive disease or death, whichever came first, assessed up to 2 yearsTime from the first recorded partial or complete response using RECIST v.1.1 criteria until disease progression or death
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=11 Participants
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Duration of Response
|
NA Months
The duration of response was not reportable as there were no objective responses
|
Adverse Events
Nivolumab and Ipilimumab
Serious events: 9 serious events
Other events: 11 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Nivolumab and Ipilimumab
n=11 participants at risk
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Gastrointestinal disorders
Small Intestine Obstruction
|
18.2%
2/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Small Intestine Perforation
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Cardiac disorders
Myocarditis
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Colonic Obstruction
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Vascular disorders
Thromboembolic Event
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
General disorders
Non-Cardiac Chest Pain
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Cardiac disorders
Atrial fibrillation
|
18.2%
2/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
1/11 • Number of events 3 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 3 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
Other adverse events
| Measure |
Nivolumab and Ipilimumab
n=11 participants at risk
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Nivolumab: IV infusion per institutional guidelines and the Package Insert
Ipilimumab: IV infusion per institutional guidelines and the Package Insert
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Number of events 5 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Abdominal Pain
|
54.5%
6/11 • Number of events 6 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Ascites
|
36.4%
4/11 • Number of events 4 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Gastrointestinal disorders
Abdominal Bloating
|
27.3%
3/11 • Number of events 3 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Vascular disorders
Thromboembolic Event
|
18.2%
2/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
18.2%
2/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
2/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Investigations
Hypokalemia
|
27.3%
3/11 • Number of events 3 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Investigations
Hyponatremia
|
18.2%
2/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
18.2%
2/11 • Number of events 2 • From ICF signature to 100 days following the last administration of study treatment.
All Serious Adverse Events or pregnancies that occur following the subject's written consent to participate in the study through 100 days of discontinuation of dosing must be reported. At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by examination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution/Investigator shall provide sponsor with a copy of each publication at the earliest practicable time, but in any event not less than thirty (30) days prior to its submission to a journal, publisher, or meeting or fifteen (15) days prior to any public disclosure of any manuscript or other public disclosure (e.g., presentation).
- Publication restrictions are in place
Restriction type: OTHER