Trial Outcomes & Findings for INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (NCT NCT03277352)
NCT ID: NCT03277352
Last Updated: 2021-07-22
Results Overview
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Screening through 60 days after end of treatment, up to approximately 18 months
Results posted on
2021-07-22
Participant Flow
The study was conducted at 2 different sites in USA. A total of 10 participants were enrolled in the study.
A total of 10 participants were screened and enrolled in the study.
Participant milestones
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Overall Study
Study Terminated By Sponsor
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Baseline characteristics by cohort
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
n=10 Participants
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening through 60 days after end of treatment, up to approximately 18 monthsPopulation: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Outcome measures
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
n=10 Participants
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
|
10 Participants
|
PRIMARY outcome
Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 monthsPopulation: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
Outcome measures
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
n=10 Participants
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
|
3 Participants
|
PRIMARY outcome
Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 monthsPopulation: The study was terminated early and no participants enrolled in Phase 2 of the study.
Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.Population: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.
Outcome measures
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
n=10 Participants
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
|
7 Participants
|
SECONDARY outcome
Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 monthsPopulation: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.
Outcome measures
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
n=10 Participants
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
|
NA days
Interval 273.0 to
The median duration of response is not estimable if less than half of the participants had an event (progression or death).
|
SECONDARY outcome
Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 monthsPopulation: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
Defined as time from first report of SD or better until disease progression or death from any cause.
Outcome measures
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
n=10 Participants
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
mRECIST
|
NA days
Interval 525.0 to
The median duration of response is not estimable if less than half of the participants had an event (progression or death).
|
|
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
RECIST
|
525 days
Interval 92.0 to
The number of responders is not enough to estimate a standard error for the confidence interval.
|
SECONDARY outcome
Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 monthsPopulation: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
Outcome measures
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
n=10 Participants
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
mRECIST
|
17.36 months
Interval 2.05 to
The number of responders is not enough to estimate a standard error for the confidence interval.
|
|
Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
RECIST
|
4.20 months
Interval 0.73 to
The number of responders is not enough to estimate a standard error for the confidence interval.
|
SECONDARY outcome
Timeframe: At 1 year and 2 years.Population: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
Defined as the time from the start of combination therapy until death due to any cause.
Outcome measures
| Measure |
INCAGN01876 + Pembrolizumab + Epacadostat
n=10 Participants
INCAGN01876 in combination with pembrolizumab and epacadostat
|
|---|---|
|
Phase 1 & Phase 2: Overall Survival
|
25.59 months
Interval 16.76 to
upper limit is not estimable
|
Adverse Events
INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID
Serious events: 3 serious events
Other events: 10 other events
Deaths: 4 deaths
Total
Serious events: 3 serious events
Other events: 10 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID
n=10 participants at risk
INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID
|
Total
n=10 participants at risk
Total
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Eye disorders
Uveitis
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
Other adverse events
| Measure |
INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID
n=10 participants at risk
INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID
|
Total
n=10 participants at risk
Total
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Endocrine disorders
Adrenal insufficiency
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
General disorders
Axillary pain
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Immune system disorders
Drug hypersensitivity
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Eye disorders
Eye irritation
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
General disorders
Fatigue
|
30.0%
3/10 • Number of events 4 • up to 18 months
|
30.0%
3/10 • Number of events 4 • up to 18 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Investigations
Hydrogen breath test abnormal
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
|
Investigations
Lipase increased
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Eye disorders
Macular hole
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Gastrointestinal disorders
Melaena
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
30.0%
3/10 • Number of events 3 • up to 18 months
|
30.0%
3/10 • Number of events 3 • up to 18 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
3/10 • Number of events 4 • up to 18 months
|
30.0%
3/10 • Number of events 4 • up to 18 months
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3 • up to 18 months
|
30.0%
3/10 • Number of events 3 • up to 18 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
|
Investigations
Weight decreased
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
20.0%
2/10 • Number of events 2 • up to 18 months
|
|
Investigations
White blood cell count decreased
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
10.0%
1/10 • Number of events 1 • up to 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER