Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

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.

Pembrolizumab

Nivolumab

Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion

Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion

Phase 2 expansion of JTX-2011 by IV infusion

Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion

Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion

Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion

Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion

Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion

JTX-2011

Stew Kroll

JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

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 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.

JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors

Phase 1/2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX-2011 Alone and in Combination With Nivolumab, Ipilimumab, or Pembrolizumab in Adult Subjects With Advanced and/or Refractory Solid Tumor Malignancies

Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated

Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."

Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Number of participants with at least one dose limiting toxicity (DLT)

Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review

Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)

Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.

Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.

Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.

Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.

The time from first dose date to the date of death for any cause

The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.

Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion

JTX-2011: Specified dose on specified days

Part A (JTX-2011)

Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion

JTX-2011: Specified dose on specified days

Nivolumab: Specified dose on specified days

Part B (JTX-2011 + Nivolumab)

Phase 2 expansion of JTX-2011 by IV infusion

JTX-2011: Specified dose on specified days

Part C (JTX-2011)

Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion

JTX-2011: Specified dose on specified days

Nivolumab: Specified dose on specified days

Part D (JTX-2011 + Nivolumab)

Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion

JTX-2011: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Part E (JTX-2011 + Ipilimumab)

Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion

JTX-2011: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Part F (JTX-2011 + Ipilimumab)

Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion

JTX-2011: Specified dose on specified days

Pembrolizumab: Specified dose on specified days

Part G (JTX-2011 + Pembrolizumab)

Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion

JTX-2011: Specified dose on specified days

Pembrolizumab: Specified dose on specified days

Part H (JTX-2011 + Pembrolizumab)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Parts F and H were never opened as clinical and translational data from ICONIC suggests that alternative regimens may be preferable to those proposed in Parts F and H.

Stew Kroll, Chief Development Officer

Number of Participants With Treatment Emergent Adverse Events (TEAE)

Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)

Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)

Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)

Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)

Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)

Part C and D did not have any participants analyzed for this outcome measure because DLT is only relevant to the Phase 1 parts of study (Part A, Part B, Part E and Part G).

Number of Participants With Dose Limiting Toxicities

Response Evaluable Set: subjects who received any study drug and have a baseline tumor assessment, and either has at least one post-baseline tumor assessment scan and/or discontinued treatment due to death or disease progression The number of participants analyzed is zero for Part F and Part H because there were no participants enrolled in those two groups of the study

Overall Response Rate

Disease Control Rate

Progression Free Survival

The 95% CI is not estimable by Kaplan-Meier method for Part E since the probability of event was 0.

6 Month Landmark Progression Free Survival

12 Month Landmark Progression Free Survival

Landmark Overall Survival at 6 Months

Landmark Overall Survival at 12 Months

Overall Survival

Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days

Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days

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.
JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors	NCT02904226	Cancer	JTX-2011 Nivolumab Ipilimumab Pembrolizumab	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.

Spots Global Cancer Trial Database for icos agonist monoclonal antibody