Trial Outcomes & Findings for Nivolumab Ipilimumab in Patients With hyperMutated Cancers Detected in Blood (NIMBLe) (NCT NCT03461952)

NCT ID: NCT03461952

Last Updated: 2024-02-22

Results Overview

Objective Response Rate by RECIST 1.1: CR, PR, SD, or PD

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

36 months

Results posted on

2024-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Nivolumab 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab n=2 Participants 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab n=2 Participants Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg	Total n=4 Participants Total of all reporting groups
Age, Continuous	53 years n=2 Participants	53 years n=2 Participants	53 years n=4 Participants
Sex: Female, Male Female	0 Participants n=2 Participants	1 Participants n=2 Participants	1 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=2 Participants	1 Participants n=2 Participants	3 Participants n=4 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 36 months

Population: The study was pre-maturely closed to accrual on August 2, 2019 following review of screening data which found that the prevalence of relavent mutations was lower than expected. Only 4 patients were accrued.

Objective Response Rate by RECIST 1.1: CR, PR, SD, or PD

Outcome measures

Outcome measures
Measure	Nivolumab n=2 Participants 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab n=2 Participants Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg
Objective Response Rate by RECIST 1.1	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

SECONDARY outcome

Timeframe: 36 months

Population: The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

Will be reported using percentages over all randomized patients with 90% exact confidence intervals

Outcome measures

Outcome measures
Measure	Nivolumab n=2 Participants 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab n=2 Participants Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg
Efficacy as Measured by Objective Response Rate	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

SECONDARY outcome

Timeframe: 36 months

Population: The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

Response rates will be reported using percentages over all patients who have received at least one dose of treatment with 90% exact CI of each arm in a non-comparative analysis

Outcome measures

Outcome measures
Measure	Nivolumab n=2 Participants 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab n=2 Participants Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg
Duration of Response	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

SECONDARY outcome

Timeframe: 36 months

Population: The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

AE rates will be reported using percentages with 90% exact CI

Outcome measures

Outcome measures
Measure	Nivolumab n=2 Participants 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab n=2 Participants Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg
Number and Severity of Adverse Events Using CTCAE 5.0	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

SECONDARY outcome

Timeframe: 36 months

Population: The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

Correlation between POLE or POLD1 mutations in tumor and POLE or POLD1 mutations in blood: Will be assessed by Fischer's exact test in each arm

Outcome measures

Outcome measures
Measure	Nivolumab n=2 Participants 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab n=2 Participants Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg
Correlation Between POLE or POLD1 Mutations in Tumor and POLE or POLD1 Mutations in Blood	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

SECONDARY outcome

Timeframe: 36 months

Population: The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

iRECIST: iCR, iPR, iSD, iUPD, iUPD/PD

Outcome measures

Outcome measures
Measure	Nivolumab n=2 Participants 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab n=2 Participants Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg
To Evaluate Response by iRECIST	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.	NA Participants The actual enrolment is extremely small for the study and any form of outcome measure will inevitability leak patients' privacy.

Adverse Events

Nivolumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Nivolumab + Ipilimumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nivolumab n=2 participants at risk 240mg Q2W Nivolumab: 240mg	Nivolumab + Ipilimumab n=2 participants at risk Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W Nivolumab: 240mg Ipilimumab: 1mg/kg
Gastrointestinal disorders Constipation	50.0% 1/2 • 36 months.	50.0% 1/2 • 36 months.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • 36 months.	0.00% 0/2 • 36 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • 36 months.	50.0% 1/2 • 36 months.

Additional Information

Janet Dancey

Canadian Cancer Trials Group

Phone: 613-533-6430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place