Trials / Terminated
TerminatedNCT04549025
Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen
Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Jounce Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, open-label study to evaluate PD-1 inhibitor pimivalimab (JTX-4014) alone and in combination with vopratelimab (JTX-2011), an ICOS agonist, in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum-based chemotherapy regimen.
Detailed description
Pimivalimab is a fully human IgG4 monoclonal antibody designed to specifically bind to programmed cell death receptor protein-1 (PD-1) and block its interaction with its ligands, programmed cell death receptor protein-1 ligand 1 (PD-L1) and programmed cell death receptor protein-1 ligand 2 (PD-L2), to augment anti-tumor T cell activity. 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 a Phase 2, open label study to evaluate the efficacy, safety, tolerability of pimivalimab alone and in combination with vopratelimab in biomarker-selected adult subjects with metastatic non-small cell lung cancer (NSCLC) who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum-based chemotherapy regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pimivalimab | Specified dose on specified days |
| DRUG | Vopratelimab | Specified dose on specified days |
Timeline
- Start date
- 2020-10-19
- Primary completion
- 2024-04-25
- Completion
- 2024-04-25
- First posted
- 2020-09-16
- Last updated
- 2024-05-22
Locations
72 sites across 14 countries: Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, Hungary, Latvia, Moldova, Romania, Russia, Serbia, Slovakia, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04549025. Inclusion in this directory is not an endorsement.