Trial Outcomes & Findings for A Study of the Safety and Tolerability of BMS-986183 in Patients With Liver Cancer (NCT NCT02828124)
NCT ID: NCT02828124
Last Updated: 2019-01-30
Results Overview
Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.
TERMINATED
PHASE1/PHASE2
25 participants
First dose up to approximately 24 months
2019-01-30
Participant Flow
There were 10 subjects were treated in this study. All 10 subjects were enrolled in BMS-986183 escalation (Part 1)
Participant milestones
| Measure |
BMS-986183 3 mg
Dose escalation in combination with Nivolumab
|
BMS-986183 9 mg
Dose escalation in combination with Nivolumab
|
BMS-986183 18 mg
Dose escalation in combination with Nivolumab
|
BMS-986183 36 mg
Dose escalation in combination with Nivolumab
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
1
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
6
|
Reasons for withdrawal
| Measure |
BMS-986183 3 mg
Dose escalation in combination with Nivolumab
|
BMS-986183 9 mg
Dose escalation in combination with Nivolumab
|
BMS-986183 18 mg
Dose escalation in combination with Nivolumab
|
BMS-986183 36 mg
Dose escalation in combination with Nivolumab
|
|---|---|---|---|---|
|
Overall Study
Disease Progression
|
1
|
2
|
1
|
4
|
|
Overall Study
AE Unrelated to Study Drug
|
0
|
0
|
0
|
1
|
|
Overall Study
Subject Withdrew Consent
|
0
|
0
|
0
|
1
|
Baseline Characteristics
All treated participants
Baseline characteristics by cohort
| Measure |
BMS-986183 3 mg
n=1 Participants
Dose escalation in combination with Nivolumab
|
BMS-986183 9 mg
n=2 Participants
Dose escalation in combination with Nivolumab
|
BMS-986183 18 mg
n=1 Participants
Dose escalation in combination with Nivolumab
|
BMS-986183 36 mg
n=6 Participants
Dose escalation in combination with Nivolumab
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.0 Years
STANDARD_DEVIATION NA • n=5 Participants • All treated participants
|
67.5 Years
STANDARD_DEVIATION 4.9 • n=7 Participants • All treated participants
|
57.0 Years
STANDARD_DEVIATION NA • n=5 Participants • All treated participants
|
49.5 Years
STANDARD_DEVIATION 8.6 • n=4 Participants • All treated participants
|
54.5 Years
STANDARD_DEVIATION 10.0 • n=21 Participants • All treated participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants • All treated participants
|
0 Participants
n=7 Participants • All treated participants
|
0 Participants
n=5 Participants • All treated participants
|
1 Participants
n=4 Participants • All treated participants
|
1 Participants
n=21 Participants • All treated participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants • All treated participants
|
2 Participants
n=7 Participants • All treated participants
|
1 Participants
n=5 Participants • All treated participants
|
5 Participants
n=4 Participants • All treated participants
|
9 Participants
n=21 Participants • All treated participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants • All treated participants
|
0 Participants
n=7 Participants • All treated participants
|
0 Participants
n=5 Participants • All treated participants
|
1 Participants
n=4 Participants • All treated participants
|
1 Participants
n=21 Participants • All treated participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants • All treated participants
|
0 Participants
n=7 Participants • All treated participants
|
0 Participants
n=5 Participants • All treated participants
|
0 Participants
n=4 Participants • All treated participants
|
0 Participants
n=21 Participants • All treated participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants • All treated participants
|
2 Participants
n=7 Participants • All treated participants
|
1 Participants
n=5 Participants • All treated participants
|
5 Participants
n=4 Participants • All treated participants
|
9 Participants
n=21 Participants • All treated participants
|
PRIMARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Evaluated by comparing the incidence of Serious Adverse Events (SAEs) among subjects using their assigned treatment for at least one day.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Evaluated by comparing the incidence of Adverse Events leading to discontinuation among subjects using their assigned treatment for at least one day.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Evaluated by comparing the incidence of Adverse Events leading to death among subjects using their assigned treatment for at least one day.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Defined as BOR designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Defined as the total number of subjects whose BOR is either a CR or PR divided by the total number of subjects in the population of interest
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. For those subjects who remain alive and have not progressed or received subsequent therapy, DoR will be censored on the date of last tumor assessment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Defined as the time from the first dose of study drug to the date of the first objective documentation of tumor progression or death due to any cause. Subjects who did not progress nor died will be censored on the date of their last tumor assessment. Subjects who did not have any on-study tumor assessments will be censored on the date of the first dose of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
Defined as the proportion of subjects who remain progression free and surviving at 't' weeks (t=12, 24, 36, etc). The proportion will be calculated by the product-limit method (Kaplan-Meier \[K-M\] estimate) which takes into account censored data
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first does up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
To characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Cmax
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Tmax.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First does up to appromimately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AUC(0-T)\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
To characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AUC(TAU).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
To characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by (Ctrough)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by CLT
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Vss
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
(to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Vz.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI\_Cmax.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI\_Ctau.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
To characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI\_AUC(TAU).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
To characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Css,avg.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
to characterize the PK of the total antibody \[unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites\], active ADC \[antibody conjugated to tubulysin\], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by T-HALF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
To assess the effect of dosage regimen and exposure \[active ADC and unconjugated tubulysin\] of BMS-986183 as monotherapy on the QT interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose up to approximately 24 monthsPopulation: The study was terminated and data is not reported for privacy reasons.
The immunogenicity of BMS-986183 (as monotherapy and in combination with nivolumab) will be measured by assessment of the presence or absence of specific ADA to BMS-986183. The incidence of positive ADA will be calculated.
Outcome measures
Outcome data not reported
Adverse Events
BMS-986183 ESC 3 mg
BMS-986183 ESC 9 mg
BMS-986183 ESC 18 mg
BMS-986183 ESC 36 mg
Serious adverse events
| Measure |
BMS-986183 ESC 3 mg
n=1 participants at risk
Dose escalation in combination with Nivolumab
|
BMS-986183 ESC 9 mg
n=2 participants at risk
Dose escalation in combination with Nivolumab
|
BMS-986183 ESC 18 mg
n=1 participants at risk
Dose escalation in combination with Nivolumab
|
BMS-986183 ESC 36 mg
n=6 participants at risk
Dose escalation in combination with Nivolumab
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
Other adverse events
| Measure |
BMS-986183 ESC 3 mg
n=1 participants at risk
Dose escalation in combination with Nivolumab
|
BMS-986183 ESC 9 mg
n=2 participants at risk
Dose escalation in combination with Nivolumab
|
BMS-986183 ESC 18 mg
n=1 participants at risk
Dose escalation in combination with Nivolumab
|
BMS-986183 ESC 36 mg
n=6 participants at risk
Dose escalation in combination with Nivolumab
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
33.3%
2/6 • First dose up to approximately 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
General disorders
Fatigue
|
100.0%
1/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
50.0%
3/6 • First dose up to approximately 24 months
|
|
General disorders
Pain
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
General disorders
Pyrexia
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
33.3%
2/6 • First dose up to approximately 24 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
33.3%
2/6 • First dose up to approximately 24 months
|
|
Investigations
Weight decreased
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
50.0%
3/6 • First dose up to approximately 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • First dose up to approximately 24 months
|
100.0%
2/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
33.3%
2/6 • First dose up to approximately 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
33.3%
2/6 • First dose up to approximately 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
0.00%
0/1 • First dose up to approximately 24 months
|
16.7%
1/6 • First dose up to approximately 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • First dose up to approximately 24 months
|
50.0%
1/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • First dose up to approximately 24 months
|
0.00%
0/2 • First dose up to approximately 24 months
|
100.0%
1/1 • First dose up to approximately 24 months
|
0.00%
0/6 • First dose up to approximately 24 months
|
Additional Information
Phase 1/2 Study of BMS-986183 in Subjects with Advanced Hepatocellular Carcinoma
Bristol Myers-Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER