Trial Outcomes & Findings for A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208) (NCT NCT03347123)
NCT ID: NCT03347123
Last Updated: 2022-02-28
Results Overview
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Screening through up to 100 days after end of treatment, up to approximately 24 months
Results posted on
2022-02-28
Participant Flow
Participants took part at 4 study centers in the United States from 21 March 2018 to 29 January 2021.
Participants were to be enrolled in Phase 1: Dose escalation Phase which consisted of 2 Treatment Groups: A (epacadostat, nivolumab, ipilimumab) and B (epacadostat, nivolumab and lirilumab), followed by Phase 2: a tumor-specific cohort Dose expansion Phase, which was to begin when maximum tolerated dose (MTD)/pharmacologically active dose (PAD) of epacadostat was determined in Phase 1. However, the study was terminated prior to enrollment in Phase 1: Treatment Group B and Phase 2 cohorts.
Participant milestones
| Measure |
Phase 1: Dose Escalataion: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 2: Dose Expansion: Treatment Group A: Cohort A1
Participants with unresectable or metastatic melanoma (MEL) were planned to be included in this cohort, who did not receive prior systemic therapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
|
Phase 2: Dose Expansion: Treatment Group A: Cohort A2
Participants with advanced or metastatic non-small cell lung cancer (NSCLC) were planned to be included in this cohort, who have received no more than 1 prior line of platinum-based chemotherapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
|
Phase 2: Dose Expansion: Treatment Group B: Cohort B1
Participants with recurrent or metastatic serotonin norepinephrine reuptake inhibitor (SCCHN) were planned to be included in this cohort, who received no more than 1 prior line of platinum-based chemotherapy for recurrent or metastatic disease to receive epacadostat in combination with nivolumab and lirilumab at the MTD/PAD determined from dose escalation phase.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: Dose Escalataion: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 2: Dose Expansion: Treatment Group A: Cohort A1
Participants with unresectable or metastatic melanoma (MEL) were planned to be included in this cohort, who did not receive prior systemic therapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
|
Phase 2: Dose Expansion: Treatment Group A: Cohort A2
Participants with advanced or metastatic non-small cell lung cancer (NSCLC) were planned to be included in this cohort, who have received no more than 1 prior line of platinum-based chemotherapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
|
Phase 2: Dose Expansion: Treatment Group B: Cohort B1
Participants with recurrent or metastatic serotonin norepinephrine reuptake inhibitor (SCCHN) were planned to be included in this cohort, who received no more than 1 prior line of platinum-based chemotherapy for recurrent or metastatic disease to receive epacadostat in combination with nivolumab and lirilumab at the MTD/PAD determined from dose escalation phase.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason not Specified
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)
Baseline characteristics by cohort
| Measure |
Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
n=5 Participants
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
n=6 Participants
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 8.57 • n=7 Participants
|
59.1 years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
90.464 kilogram (kg)
STANDARD_DEVIATION 16.3665 • n=5 Participants
|
81.255 kilogram (kg)
STANDARD_DEVIATION 26.5702 • n=7 Participants
|
85.441 kilogram (kg)
STANDARD_DEVIATION 21.9832 • n=5 Participants
|
|
Height
|
173.2 centimeter (cm)
STANDARD_DEVIATION 9.20 • n=5 Participants
|
174.2 centimeter (cm)
STANDARD_DEVIATION 3.25 • n=7 Participants
|
173.7 centimeter (cm)
STANDARD_DEVIATION 6.28 • n=5 Participants
|
PRIMARY outcome
Timeframe: Screening through up to 100 days after end of treatment, up to approximately 24 monthsPopulation: Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy. Treatment group B was excluded from this analysis as no participants were enrolled.
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Outcome measures
| Measure |
Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
n=5 Participants
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
n=6 Participants
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 2: Dose Expansion: Treatment Group B: Cohort B1
Participants with recurrent or metastatic serotonin norepinephrine reuptake inhibitor (SCCHN) were planned to be included in this cohort, who received no more than 1 prior line of platinum-based chemotherapy for recurrent or metastatic disease to receive epacadostat in combination with nivolumab and lirilumab at the MTD/PAD determined from dose escalation phase.
|
|---|---|---|---|
|
Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
100 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)Population: As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned.
ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)Population: As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned.
ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)Population: As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned.
DOR was defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)Population: As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned.
PFS was defined as the time from the start of combination therapy until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)Population: As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned.
DOR was defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)Population: As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned.
PFS was defined as the time from the start of combination therapy until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening through up to 100 days for treatment Group A and 150 days for treatment Group B after end of treatment, up to approximately 24 monthsPopulation: As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned.
A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Total
Serious events: 5 serious events
Other events: 11 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
n=5 participants at risk
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
n=6 participants at risk
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Total
n=11 participants at risk
Total
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
General disorders
Pain
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
Other adverse events
| Measure |
Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
n=5 participants at risk
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
n=6 participants at risk
Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
|
Total
n=11 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Investigations
Amylase increased
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
18.2%
2/11 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
40.0%
2/5 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
18.2%
2/11 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Ascites
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Infections and infestations
Bronchitis
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
3/5 • Number of events 7 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
36.4%
4/11 • Number of events 8 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Eye disorders
Diplopia
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
27.3%
3/11 • Number of events 3 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Infections and infestations
Herpes zoster
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Endocrine disorders
Hyperthyroidism
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
27.3%
3/11 • Number of events 3 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Endocrine disorders
Hypopituitarism
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Endocrine disorders
Hypothyroidism
|
40.0%
2/5 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
33.3%
2/6 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
36.4%
4/11 • Number of events 4 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Investigations
Lipase increased
|
40.0%
2/5 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
27.3%
3/11 • Number of events 4 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
18.2%
2/11 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.0%
1/5 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
18.2%
2/11 • Number of events 3 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
33.3%
2/6 • Number of events 3 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
27.3%
3/11 • Number of events 4 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
33.3%
2/6 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
27.3%
3/11 • Number of events 3 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
2/5 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
27.3%
3/11 • Number of events 3 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
18.2%
2/11 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Infections and infestations
Staphylococcal infection
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
33.3%
2/6 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
27.3%
3/11 • Number of events 3 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
0.00%
0/6 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
18.2%
2/11 • Number of events 2 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
16.7%
1/6 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
9.1%
1/11 • Number of events 1 • Screening through up to 100 days after end of treatment, up to approximately 24 months
Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER