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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.

Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE June 6, 2019
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
% subjects with overall response (OR) [ Time Frame: 34 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03989362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • % subjects with adverse events (AEs) [ Time Frame: 34 months ]
  • % subjects with serious adverse events (SAEs) [ Time Frame: 34 months ]
  • % subjects with clinically significant change from baseline in clinical laboratory tests [ Time Frame: 34 months ]
  • % subjects with anti-drug antibodies (ADA) to treatment [ Time Frame: 34 months ]
  • % of subjects with neutralizing antibodies (NAb) to treatment [ Time Frame: 34 months ]
  • % of subjects with clinically significant changes in electrocardiogram (ECG) measurements [ Time Frame: 34 months ]
  • Area under the serum concentration-time curve (AUC) [ Time Frame: 34 months ]
  • Maximum measured concentration in serum (Cmax) [ Time Frame: 34 months ]
  • Time from dosing to maximum measured concentration (tmax) [ Time Frame: 34 months ]
  • Terminal half-life (t1/2) [ Time Frame: 34 months ]
  • Total clearance of the analyte in serum (CL) [ Time Frame: 34 months ]
  • Apparent volume of distribution during specific time points [ Time Frame: 34 months ]
  • Median duration of response (DOR) [ Time Frame: 34 months ]
  • Disease control rate (DCR) [ Time Frame: 34 months ]
  • Landmark progression free survival (PFS) [ Time Frame: 34 months ]
  • Median PFS [ Time Frame: 34 months ]
  • Median overall survival (OS) [ Time Frame: 34 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: Vopratelimab
    Specified dose on specified days
    Other Name: JTX-2011
  • Drug: Ipilimumab
    Specified dose on specified days
    Other Name: Yervoy
Study Arms  ICMJE
  • Experimental: LM1
    Phase 2 study of vopratelimab by intravenous (IV) infusion administered in combination with ipilimumab by IV infusion in NSCLC
    Interventions:
    • Drug: Vopratelimab
    • Drug: Ipilimumab
  • Experimental: LT1
    Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in NSCLC
    Interventions:
    • Drug: Vopratelimab
    • Drug: Ipilimumab
  • Experimental: UM1
    Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
    Interventions:
    • Drug: Vopratelimab
    • Drug: Ipilimumab
  • Experimental: UT1
    Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
    Interventions:
    • Drug: Vopratelimab
    • Drug: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019)
226
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel McComb EMERGE@jouncetx.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989362
Other Study ID Numbers  ICMJE JTX-2011-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jounce Therapeutics, Inc.
Study Sponsor  ICMJE Jounce Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ellen Hooper, MD, FAAP Jounce Therapeutics, Inc.
PRS Account Jounce Therapeutics, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP