Trial Outcomes & Findings for BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer (NCT NCT03695250)
NCT ID: NCT03695250
Last Updated: 2023-08-22
Results Overview
Number of participants with adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Up to 2 years.
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
Treatment (BMS-986205 and Nivolumab)
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer
Baseline characteristics by cohort
| Measure |
Treatment (BMS-986205 and Nivolumab)
n=8 Participants
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO 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
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 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
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years.Number of participants with adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Outcome measures
| Measure |
Treatment (BMS-986205 and Nivolumab)
n=8 Participants
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV
|
|---|---|
|
Adverse Events (AE)
Diarrhea
|
2 participants
|
|
Adverse Events (AE)
Oral pain
|
1 participants
|
|
Adverse Events (AE)
Flatulence
|
1 participants
|
|
Adverse Events (AE)
Pruritus
|
1 participants
|
|
Adverse Events (AE)
Fatigue
|
1 participants
|
|
Adverse Events (AE)
Dyspnea
|
1 participants
|
|
Adverse Events (AE)
Maculopapular rash
|
2 participants
|
|
Adverse Events (AE)
Alk phos increased
|
2 participants
|
|
Adverse Events (AE)
AST increased
|
3 participants
|
|
Adverse Events (AE)
ALT increased
|
3 participants
|
|
Adverse Events (AE)
Musculoskeletal pain
|
1 participants
|
|
Adverse Events (AE)
Anorexia
|
1 participants
|
|
Adverse Events (AE)
Malaise
|
1 participants
|
|
Adverse Events (AE)
TSH elevation
|
1 participants
|
|
Adverse Events (AE)
Abdominal pain
|
1 participants
|
|
Adverse Events (AE)
Hyperglycemia
|
1 participants
|
|
Adverse Events (AE)
Pancreatitis
|
1 participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 years, 1 month.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (BMS-986205 and Nivolumab)
n=8 Participants
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV
|
|---|---|
|
Objective Response Rate (ORR)
|
12.5 percentage of participans
Interval 0.3 to 52.7
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsDCR is defined as the percentage of patients that achieve an objective tumor response or have stable disease to therapy. The DCR will be estimated as the proportion of participants who experience an objective response, along with its exact 95% confidence interval.
Outcome measures
| Measure |
Treatment (BMS-986205 and Nivolumab)
n=8 Participants
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV
|
|---|---|
|
Disease Control Rate (DCR)
|
50 percentage of participants
Interval 15.7 to 84.3
|
SECONDARY outcome
Timeframe: From date of enrollment to time of progression or death, whichever occurs first, assessed up to 2.5 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions\>
Outcome measures
| Measure |
Treatment (BMS-986205 and Nivolumab)
n=8 Participants
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
|
8.5 Weeks
Interval 4.8 to
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or progressive disease (PD) is objectively documented, assessed up to 2.5 yearsPopulation: End timepoints of response were not collected from any participants to assess this outcome measure.
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of enrollment to death from any cause, assessed up to 2.5 yearsOS will be analyzed using Kaplan-Meier methods; medians and 95% confidence intervals will be computed.
Outcome measures
| Measure |
Treatment (BMS-986205 and Nivolumab)
n=8 Participants
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV
|
|---|---|
|
Overall Survival (OS)
|
NA Days
Standard Error NA
Insufficient number of participants with events
|
Adverse Events
Treatment (BMS-986205 and Nivolumab)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (BMS-986205 and Nivolumab)
n=8 participants at risk
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Investigations
AST increase
|
12.5%
1/8 • Number of events 1 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
12.5%
1/8 • Number of events 1 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
Other adverse events
| Measure |
Treatment (BMS-986205 and Nivolumab)
n=8 participants at risk
Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
IDO1 Inhibitor BMS-986205: Given PO Nivolumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Gastrointestinal disorders
Flatulance
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
General disorders
Fatigue
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
25.0%
2/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Investigations
Alk phos increased
|
25.0%
2/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Investigations
AST increased
|
37.5%
3/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Investigations
ALT increased
|
37.5%
3/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
General disorders
Malaise
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Metabolism and nutrition disorders
TSH elevation
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
12.5%
1/8 • All cause mortality - assessed for up to about 2.5 years. Serious and Other Adverse Events assessed for up to 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place