CancerPhase 1/2NCT04319224
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
A Phase 1/2 study testing Vopratelimab, Ipilimumab and Nivolumab in people with Cancer, run by Jounce Therapeutics, Inc. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Vopratelimab, Ipilimumab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Mar 2020to 3 Jan 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia Health Systems
Charlottesville, Virginia, 22908
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study
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).
Read the 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.
- Conditions
- Cancer
- Being tested
- Vopratelimab, Ipilimumab, Nivolumab
- Keywords
- JTX-2011, Vopratelimab, Ipilimumab, Nivolumab, ICOS, Anti-CTLA-4, PD-1, PD-L1, Immunotherapy, Immuno-oncology, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VopratelimabDrug
Also called JTX-2011
Specified dose on specified days
IpilimumabDrug
Also called Yervoy
Specified dose on specified days
NivolumabDrug
Also called Opdivo
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Vopratelimab | Experimental | Participants will continue to receive vopratelimab monotherapy per parent protocol. Receives: Drug: Vopratelimab |
| Vopratelimab with ipilimumab | Experimental | Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol. Receives: Drug: Vopratelimab; Drug: Ipilimumab |
| Vopratelimab with nivolumab | Experimental | Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol. Receives: Drug: Vopratelimab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Adverse Events (AEs)
Percentage of subjects with at least one AE
Measured: Approximately 34 months
Percentage of Subjects With Serious Adverse Events (SAEs)
Percentage of subjects with at least one SAE
Measured: Approximately 34 months
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)
Measured: Approximately 34 months
Secondary outcomes (1)
Median Progression Free Survival (mPFS)
mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study)
Measured: Approximately 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start10 Mar 2020
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Why it stopped: Sponsor decision to discontinue providing study drug to patients who have been on study treatment for more than two years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jounce Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stew Kroll, Study director, Jounce Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319224
- Sponsor's protocol ID
- JTX-2011-R01
- Status last verified
- May 2024
- First submitted
- 20 Mar 2020
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study
- ClinicalTrials.gov ID
- NCT04319224
- Acronym / sponsor ID
- JTX-2011-R01
- Conditions
- Cancer
- Keywords
- JTX-2011, Vopratelimab, Ipilimumab, Nivolumab, ICOS, Anti-CTLA-4, PD-1, PD-L1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to discontinue providing study drug to patients who have been on study treatment for more than two years
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jounce Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vopratelimab | Experimental | Drug: VopratelimabParticipants will continue to receive vopratelimab monotherapy per parent protocol. |
| Vopratelimab with ipilimumab | Experimental | Drug: Vopratelimab, Drug: IpilimumabParticipants will continue to receive vopratelimab in combination with ipilimumab per parent protocol. |
| Vopratelimab with nivolumab | Experimental | Drug: Vopratelimab, Drug: NivolumabParticipants will continue to receive vopratelimab in combination with nivolumab per parent protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VopratelimabAlso: JTX-2011Specified dose on specified days | Drug | Vopratelimab, Vopratelimab with ipilimumab, Vopratelimab with nivolumab |
| IpilimumabAlso: YervoySpecified dose on specified days | Drug | Vopratelimab with ipilimumab |
| NivolumabAlso: OpdivoSpecified dose on specified days | Drug | Vopratelimab with nivolumab |
Primary outcome
Percentage of Subjects With Adverse Events (AEs)
Time frame: Approximately 34 months
Percentage of subjects with at least one AE
Percentage of Subjects With Serious Adverse Events (SAEs)
Time frame: Approximately 34 months
Percentage of subjects with at least one SAE
Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests
Time frame: 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)
1 secondary outcome
Median Progression Free Survival (mPFS)
Time frame: Approximately 34 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stew Kroll study director
Jounce Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vopratelimab, Ipilimumab and Nivolumab in people with Cancer, run by Jounce Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Adverse Events (AEs) (time frame: Approximately 34 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.