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

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ClinicalTrials.gov Identifier: NCT03989362
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jounce Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Vopratelimab Drug: Ipilimumab Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) 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
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: LM1
Phase 2 study of vopratelimab by intravenous (IV) infusion administered in combination with ipilimumab by IV infusion in NSCLC
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011

Drug: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Experimental: LT1
Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in NSCLC
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011

Drug: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Experimental: UM1
Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011

Drug: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Experimental: UT1
Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011

Drug: Ipilimumab
Specified dose on specified days
Other Name: Yervoy




Primary Outcome Measures :
  1. % subjects with overall response (OR) [ Time Frame: 34 months ]

Secondary Outcome Measures :
  1. % subjects with adverse events (AEs) [ Time Frame: 34 months ]
  2. % subjects with serious adverse events (SAEs) [ Time Frame: 34 months ]
  3. % subjects with clinically significant change from baseline in clinical laboratory tests [ Time Frame: 34 months ]
  4. % subjects with anti-drug antibodies (ADA) to treatment [ Time Frame: 34 months ]
  5. % of subjects with neutralizing antibodies (NAb) to treatment [ Time Frame: 34 months ]
  6. % of subjects with clinically significant changes in electrocardiogram (ECG) measurements [ Time Frame: 34 months ]
  7. Area under the serum concentration-time curve (AUC) [ Time Frame: 34 months ]
  8. Maximum measured concentration in serum (Cmax) [ Time Frame: 34 months ]
  9. Time from dosing to maximum measured concentration (tmax) [ Time Frame: 34 months ]
  10. Terminal half-life (t1/2) [ Time Frame: 34 months ]
  11. Total clearance of the analyte in serum (CL) [ Time Frame: 34 months ]
  12. Apparent volume of distribution during specific time points [ Time Frame: 34 months ]
  13. Median duration of response (DOR) [ Time Frame: 34 months ]
  14. Disease control rate (DCR) [ Time Frame: 34 months ]
  15. Landmark progression free survival (PFS) [ Time Frame: 34 months ]
  16. Median PFS [ Time Frame: 34 months ]
  17. Median overall survival (OS) [ Time Frame: 34 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
  2. Male or female ≥ 18 years of age
  3. Locally advanced, inoperable or metastatic NSCLC or urothelial cancer, with evaluable or measurable disease, according to RECIST v1.1, with at least one measurable lesion
  4. Prior treatment with a PD-1/PD -L1 inhibitor for at least 3 months
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. Predicted life expectancy ≥ 3 months
  7. Have laboratory values in accordance with the study protocol
  8. If medical history of the following, case should be reviewed with the Medical Monitor: prior biliary tract disorders (as based on Hepatobiliary system organ class high level terms of obstructive bile duct disorders, hepatic vascular disorders, structural and other bile duct disorders) or portal hypertension and/or hepatic vascular disorders
  9. Women of child-bearing potential (WOCBP): negative serum pregnancy test within 72 hours prior to planned C1D1 and a negative urine pregnancy test on C1D1 and any subsequent study drug administration day
  10. WOCBP and males whose partners are WOCBP must agree to use a highly effective method of birth control throughout their participation and for 5 months following the last study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.

Exclusion Criteria:

  1. Concurrent anticancer treatment (either approved or investigational, excluding radiation therapy)
  2. Prior anticancer therapies within the timeframes specified below, or ongoing toxicity from prior therapy > Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Exceptions include > Grade 1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia) and are approved by the Medical Monitor:

    1. Biologic therapy, including immunotherapy, within 21 days prior to C1D1
    2. Chemotherapy within 21 days (42 days for mitomycin or nitrosoureas) prior to C1D1
    3. Anti-CTLA-4 or anti-ICOS therapy at any time
    4. Chimeric antigen receptor T-cell therapy at any time
    5. Organ transplantation, including allogeneic or autologous stem-cell transplantation, at any time
  3. Major surgery (excluding minor procedures, e.g., placement of vascular access, biopsy, etc.) within 4 weeks prior to C1D1
  4. Live vaccines within 30 days prior to C1D1 (inactivated vaccines are allowed; seasonal vaccines should be up to date prior to C1D1)
  5. History of immune-related adverse events (irAEs) leading to treatment discontinuation. Subjects who discontinued prior immunotherapies for irAEs that are well controlled with appropriate treatment may be enrolled if approved by the Medical Monitor
  6. Any active disease, including primary or acquired immunodeficiency, requiring systemic immunosuppressive therapy equivalent to ≥10 mg prednisone per day within 7 days prior to C1D1. Exception: inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease as well as a one-time dose of immunosuppressive agents used prophylactically for contrast allergies
  7. Known severe intolerance to or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous immunoglobulin preparations; history of anaphylaxis; or known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
  8. Brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
  9. Prior whole brain radiation
  10. Concurrent second malignancy at other sites that requires treatment or, in the judgment of the Investigator, may require treatment within the next year. Concurrent malignancies that do not require treatment and are clinically stable are allowed. Prior malignancies are allowed as long as the subject is not receiving specific treatment other than hormonal therapy and, in the judgment of the Investigator, is unlikely to have a recurrence
  11. Active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)
  12. Women who are pregnant or breastfeeding
  13. History of symptomatic cardiac disease that is unresponsive to surgical or medical management
  14. 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 trial data interpretation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989362


Contacts
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Contact: Rachel McComb EMERGE@jouncetx.com

Locations
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United States, California
Beverly Hills Cancer Center Not yet recruiting
Beverly Hills, California, United States, 90211
Contact: David Berz       dberz@bhcancercenter.com   
Principal Investigator: David Berz, MD         
United States, Florida
Florida Cancer Specialists Sarasota Cattlemen Recruiting
Sarasota, Florida, United States, 34232
Contact: Judy Wang, MD       JSWang@flcancer.com   
Principal Investigator: Judy Wang, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ramaswamy Govindan, MD       rgovindan@wustl.edu   
Principal Investigator: Ramaswamy Govindan, MD         
United States, New Jersey
The Valley Hospital Not yet recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Eli Kirshner, MD       kirsel@valleyhealth.com   
Principal Investigator: Eli Kirshner, MD         
United States, Rhode Island
Lifespan Cancer Institute Recruiting
Providence, Rhode Island, United States, 02903
Contact: Christopher Azzoli, MD       CAzzoli@Lifespan.org   
Principal Investigator: Christopher Azzoli, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Melissa Johnson, MD       melissa.johnson@sarahcannon.com   
Principal Investigator: Melissa Johnson, MD         
Canada, Ontario
University Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Dianne Zawisza    416-946-2913    Dianne.zawisza@uhn.ca   
Principal Investigator: Natasha Leighl, MD         
Canada, Quebec
The Research Institute of the McGill University Health Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Scott Owen, MD       scott.owen@mcgill.ca   
Principal Investigator: Scott Owen, MD         
Canada
University Institute of Cardiology and Respirology of Quebec Not yet recruiting
Québec, Canada, G1V 4G5
Contact: Brigitte Fortin    418-656-8711 ext 2639    brigitte.fortin@criucpq.ulaval.ca   
Principal Investigator: Yves Lacasse, MD         
Sponsors and Collaborators
Jounce Therapeutics, Inc.
Investigators
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Study Director: Ellen Hooper, MD, FAAP Jounce Therapeutics, Inc.

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Responsible Party: Jounce Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03989362     History of Changes
Other Study ID Numbers: JTX-2011-201
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jounce Therapeutics, Inc.:
ICOS
ICOS agonist monoclonal antibody
JTX-2011
Vopratelimab
Anti-CTLA-4
Ipilimumab
EMERGE
Immunotherapy
Immuno-Oncology
Cancer
Non-small Cell Lung Cancer
Urothelial Cancer
Additional relevant MeSH terms:
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Ipilimumab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents