Cancer
Conditions
Keywords
JTX-2011, Vopratelimab, Ipilimumab, Nivolumab, ICOS, Anti-CTLA-4, PD-1, PD-L1, Immunotherapy, Immuno-oncology, Cancer
Brief summary
JTX-2011-R01 is an open label, multicenter, rollover study that is designed to provide continued access to vopratelimab for eligible subjects with advanced solid tumor malignancies who have previously participated in a vopratelimab study (the parent study).
Detailed description
Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible Co-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is an open label, roll over study to evaluate the long-term safety of continued treatment with vopratelimab monotherapy or combination treatment.
Interventions
DRUGVopratelimab
Specified dose on specified days
DRUGIpilimumab
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
Sponsors
Jounce Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is currently receiving and tolerating vopratelimab (JTX-2011) therapy and receiving clinical benefit from study treatment in the opinion of the Investigator and/or Sponsor. * Subject has demonstrated compliance with the parent study requirements, as assessed by the Investigator and/or Sponsor, and is able and willing to comply with the necessary visits and assessments as part of the rollover study. * Written informed consent must be obtained prior to enrolling in the rollover study and receiving study treatment. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. * Women of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
Exclusion criteria
* Subject was permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason. * Subject is receiving concurrent anti-cancer treatment (excluding combination drugs such as nivolumab or ipilimumab as a component of the combination dosing regimen used in parent study). * Women who are pregnant or breastfeeding. * Subject has any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical study data interpretation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Adverse Events (AEs) | Approximately 34 months | Percentage of subjects with at least one AE |
| Percentage of Subjects With Serious Adverse Events (SAEs) | Approximately 34 months | Percentage of subjects with at least one SAE |
| Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests | Approximately 34 months | Percentage 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Progression Free Survival (mPFS) | Approximately 34 months | mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vopratelimab Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks. | 1 |
| 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. | 3 |
| Total | 4 |
Baseline characteristics
| Characteristic | Vopratelimab | Vopratelimab With Nivolumab | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 1 / 1 | 3 / 3 |
| serious Total, serious adverse events | 1 / 1 | 0 / 3 |
Outcome results
Primary
Percentage of Subjects With Adverse Events (AEs)
Percentage of subjects with at least one AE
Time frame: Approximately 34 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vopratelimab | Percentage of Subjects With Adverse Events (AEs) | 100 percentage of participants |
| Vopratelimab With Nivolumab | Percentage of Subjects With Adverse Events (AEs) | 100 percentage of participants |
Primary
Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests
Percentage 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)
Time frame: Approximately 34 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vopratelimab | Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests | 0 percentage of participants |
| Vopratelimab With Nivolumab | Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests | 67 percentage of participants |
Primary
Percentage of Subjects With Serious Adverse Events (SAEs)
Percentage of subjects with at least one SAE
Time frame: Approximately 34 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vopratelimab | Percentage of Subjects With Serious Adverse Events (SAEs) | 100 percentage of participants |
| Vopratelimab With Nivolumab | Percentage of Subjects With Serious Adverse Events (SAEs) | 0 percentage of participants |
Secondary
Median Progression Free Survival (mPFS)
mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study)
Time frame: Approximately 34 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vopratelimab | Median Progression Free Survival (mPFS) | NA months |
| Vopratelimab With Nivolumab | Median Progression Free Survival (mPFS) | NA months |