Trial Outcomes & Findings for Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy (NCT NCT03631641)
NCT ID: NCT03631641
Last Updated: 2024-07-01
Results Overview
The associated confidence intervals will be reported and used to determine if the incidence rate is significantly different from that reported among Lynch patients not receiving nivolumab, 0.33.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
At 3 years
Results posted on
2024-07-01
Participant Flow
Participant milestones
| Measure |
Treatment (Nivolumab)
Participants receive nivolumab intravenously IV over 60 minutes on day 1. Treatment repeats every 3 months for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab)
n=3 Participants
Participants receive nivolumab intravenously IV over 60 minutes on day 1. Treatment repeats every 3 months for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 3 yearsPopulation: Data was not obtained and analyzed due to early study termination
The associated confidence intervals will be reported and used to determine if the incidence rate is significantly different from that reported among Lynch patients not receiving nivolumab, 0.33.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 3 yearsPopulation: Data was not obtained and analyzed due to early study termination
The associated confidence interval will be reported and used to determine if the incidence rate is significantly different from 0.22, the reported incidence of high-risk adenomas among Lynch syndrome patients not receiving nivolumab.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 3 yearsPopulation: Data was not obtained and analyzed due to early study termination
The incidence rates of colon cancers in Lynch patients treated with nivolumab will be estimated with corresponding confidence intervals.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 3 yearsPopulation: Data was not obtained and analyzed due to early study termination
The incidence rates of non-colonic cancers in Lynch patients treated with nivolumab will be estimated with corresponding confidence intervals.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Nivolumab)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Nivolumab)
n=3 participants at risk
Participants receive nivolumab intravenously IV over 60 minutes on day 1. Treatment repeats every 3 months for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Renal and urinary disorders
decreased eGFR
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Psychiatric disorders
depression
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Immune system disorders
Allergic reaction
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Bilateral skin lesions- arms and legs- 1 lesion
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Investigations
Creatinine Increased
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Ear and labyrinth disorders
Ear Pain (left ear) radiating with headmovment
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
eczema- bilateral hands
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
General disorders
fatigue
|
66.7%
2/3 • Number of events 2 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
General disorders
fever
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Metabolism and nutrition disorders
Glucose Intolerance
|
66.7%
2/3 • Number of events 2 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Cardiac disorders
heart palpitations
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
General disorders
Localized Edema-Left Calf
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Reproductive system and breast disorders
menorrhagia
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Gastrointestinal disorders
nausea
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Nervous system disorders
neuropathy bilateral fingers
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Investigations
Platelet Count Decreased
|
66.7%
2/3 • Number of events 2 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Seborrheic Keratosis (1 forearm lesion)
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin Lesions
|
66.7%
2/3 • Number of events 2 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
squamous cell ca-5 lesions-bilateral arms and legs
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Endocrine disorders
transient thyroiditis
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Endocrine disorders
TSH decreased
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Renal and urinary disorders
urinary tract infection
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
|
Metabolism and nutrition disorders
weight loss
|
33.3%
1/3 • Number of events 1 • Adverse experiences will be graded and recorded throughout the study and during the follow-up period according, an average of 2 years.
|
Additional Information
Dr. John Hays
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-6529
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place