Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Ipilimumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Phase 2 study of vopratelimab by intravenous (IV) infusion administered in combination with ipilimumab by IV infusion in NSCLC

Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in NSCLC

Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer

Phase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in NSCLC

Phase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in urothelial cancer

Vopratelimab

Ellen Hooper, MD

JTX-2011-201 is a Phase 2, open label clinical study of vopratelimab (JTX-2011) and ipilimumab in adult subjects with non-small cell lung cancer (NSCLC) or urothelial cancer to evaluate safety and efficacy.

Vopratelimab (JTX-2011) 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 safety and efficacy of vopratelimab in combination with ipilimumab in adult subjects with advanced and/or refractory non-small cell lung cancer and urothelial cancer.

Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer

Phase 2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) Vopratelimab (JTX -2011) and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Adult Subjects With Non-small Cell Lung Cancer or Urothelial Cancer

Jounce Therapeutics, Inc.

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Enrolled patients will receive 1000 mg pimivalimab (JTX-4014) administered alone every 6 weeks (q6w).

For Cycle 1, enrolled patients will receive 0.1 mg/kg vopratelimab (JTX-2011) on Day 1, followed by 1000 mg pimivalimab (JTX-4014) on Day 8. For Cycle 2 and beyond, vopratelimab and pimivalimab will be administered in combination (on Day 1) q6w.

For Cycle 1, enrolled patients will receive 0.03 mg/kg vopratelimab (JTX-2011) on Day 1, followed by 1000 mg pimivalimab (JTX-4014) on Day 8. For Cycle 2 and beyond, vopratelimab and pimivalimab will be administered in combination (on Day 1) q6w.

Pimivalimab

Stew Kroll

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.

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.

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

Mean percent change from baseline tumor size of all measurable existing and new lesions

ORR (percentage of subjects with complete response \[CR\] + partial response \[PR\]) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Landmark PFS rate at 9 months according to RECIST v1.1

DCR (confirmed CR + confirmed PR + unconfirmed stable disease \[SD\]) according to RECIST v1.1

Change in measurable lesion size for patients with elevated tumor RNA signature score (i.e., tumor inflammation signature (TIS) vopra score ≥ 7.9)

Symptoms and General Pathology

Death

Nivolumab

Participants will continue to receive vopratelimab monotherapy per parent protocol.

Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.

Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.

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).

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.

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

An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study

Percentage of subjects with at least one AE

Percentage of subjects with at least one SAE

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)

mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study)

Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks.

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.

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.

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Stew Kroll, Chief Development Officer

Percentage of Subjects With Adverse Events (AEs)

Percentage of Subjects With Serious Adverse Events (SAEs)

Participant received vopratelimab monotherapy (by intravenous infusion) at a dose of 0.1 mg/kg every 6 weeks

Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer	NCT03989362	Cancer	Vopratelimab Ipilimumab	18 Years -	Jounce Therapeutics, Inc.
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	NCT04549025	NSCLC	Pimivalimab Vopratelimab	18 Years -	Jounce Therapeutics, Inc.
Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer	NCT03989362	Cancer	Vopratelimab Ipilimumab	18 Years -	Jounce Therapeutics, Inc.
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	NCT04319224	Cancer	Vopratelimab Ipilimumab Nivolumab	18 Years -	Jounce Therapeutics, Inc.

Spots Global Cancer Trial Database for vopratelimab

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