Trial Outcomes & Findings for Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors (NCT NCT04319224)
NCT ID: NCT04319224
Last Updated: 2024-05-30
Results Overview
Percentage of subjects with at least one AE
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Approximately 34 months
Results posted on
2024-05-30
Participant Flow
Participant milestones
| Measure |
Vopratelimab
Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks
|
Vopratelimab With Nivolumab
Participants received vopratelimab (by intravenous infusion) at a dose of 0.1 mg/kg or 0.3 mg/kg in combination with nivolumab (240 mg) every 3 weeks or every 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors
Baseline characteristics by cohort
| Measure |
Vopratelimab
n=1 Participants
Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks.
|
Vopratelimab With Nivolumab
n=3 Participants
Participants received vopratelimab (by intravenous infusion) at a dose of 0.1 mg/kg or 0.3 mg/kg in combination with nivolumab (240 mg) every 3 weeks or every 6 weeks.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
PRIMARY outcome
Timeframe: Approximately 34 monthsPercentage of subjects with at least one AE
Outcome measures
| Measure |
Vopratelimab
n=1 Participants
Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks.
|
Vopratelimab With Nivolumab
n=3 Participants
Participants received vopratelimab (by intravenous infusion) at a dose of 0.1 mg/kg or 0.3 mg/kg in combination with nivolumab (240 mg) every 3 weeks or every 6 weeks.
|
|---|---|---|
|
Percentage of Subjects With Adverse Events (AEs)
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Approximately 34 monthsPercentage of subjects with at least one SAE
Outcome measures
| Measure |
Vopratelimab
n=1 Participants
Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks.
|
Vopratelimab With Nivolumab
n=3 Participants
Participants received vopratelimab (by intravenous infusion) at a dose of 0.1 mg/kg or 0.3 mg/kg in combination with nivolumab (240 mg) every 3 weeks or every 6 weeks.
|
|---|---|---|
|
Percentage of Subjects With Serious Adverse Events (SAEs)
|
100 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Approximately 34 monthsPercentage of subjects with at least one clinically significant change from baseline in clinical laboratory tests (i.e., change requiring adjustment of dose, clinical intervention or administration of concomitant medication)
Outcome measures
| Measure |
Vopratelimab
n=1 Participants
Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks.
|
Vopratelimab With Nivolumab
n=3 Participants
Participants received vopratelimab (by intravenous infusion) at a dose of 0.1 mg/kg or 0.3 mg/kg in combination with nivolumab (240 mg) every 3 weeks or every 6 weeks.
|
|---|---|---|
|
Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests
|
0 percentage of participants
|
67 percentage of participants
|
SECONDARY outcome
Timeframe: Approximately 34 monthsPopulation: The PFS for the 1 participant receiving vopratelimab monotherapy and 2 of the 3 participants receiving vopratelimab in combination with nivolumab was censored due to non-occurrence of outcome event.
mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study)
Outcome measures
| Measure |
Vopratelimab
n=1 Participants
Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks.
|
Vopratelimab With Nivolumab
n=3 Participants
Participants received vopratelimab (by intravenous infusion) at a dose of 0.1 mg/kg or 0.3 mg/kg in combination with nivolumab (240 mg) every 3 weeks or every 6 weeks.
|
|---|---|---|
|
Median Progression Free Survival (mPFS)
|
NA months
The PFS for the 1 participant in this arm/group was censored.
|
NA months
Interval 9.8 to
The PFS for 2 of the 3 participants in this arm/group were censored; therefore, no median was reached.
|
Adverse Events
Vopratelimab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Vopratelimab With Nivolumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vopratelimab
n=1 participants at risk
Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks.
|
Vopratelimab With Nivolumab
n=3 participants at risk
Participants received vopratelimab (by intravenous infusion) at a dose of 0.1 mg/kg or 0.3 mg/kg in combination with nivolumab (240 mg) every 3weeks or every 6 weeks.
|
|---|---|---|
|
Renal and urinary disorders
Bladder transitional cell carcinoma
|
100.0%
1/1 • Number of events 1 • Approximately 34 months
|
0.00%
0/3 • Approximately 34 months
|
Other adverse events
| Measure |
Vopratelimab
n=1 participants at risk
Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks.
|
Vopratelimab With Nivolumab
n=3 participants at risk
Participants received vopratelimab (by intravenous infusion) at a dose of 0.1 mg/kg or 0.3 mg/kg in combination with nivolumab (240 mg) every 3weeks or every 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Approximately 34 months
|
66.7%
2/3 • Number of events 2 • Approximately 34 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Infections and infestations
Gastrointestinal infection
|
100.0%
1/1 • Number of events 1 • Approximately 34 months
|
0.00%
0/3 • Approximately 34 months
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 2 • Approximately 34 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 3 • Approximately 34 months
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 2 • Approximately 34 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/1 • Approximately 34 months
|
33.3%
1/3 • Number of events 1 • Approximately 34 months
|
Additional Information
Stew Kroll, Chief Development Officer
Jounce Therapeutics, Inc.
Phone: (650) 576-9679
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place