Clinical Trials /

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

NCT03989362

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: JTX-2011-201
  • NCT ID: NCT03989362

Conditions

  • Cancer

Interventions

DrugSynonymsArms
VopratelimabJTX-2011LM1
IpilimumabYervoyLM1

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
LM1ExperimentalPhase 2 study of vopratelimab by intravenous (IV) infusion administered in combination with ipilimumab by IV infusion in NSCLC
  • Vopratelimab
  • Ipilimumab
LT1ExperimentalPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in NSCLC
  • Vopratelimab
  • Ipilimumab
UM1ExperimentalPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
  • Vopratelimab
  • Ipilimumab
UT1ExperimentalPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
  • Vopratelimab
  • Ipilimumab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:% subjects with overall response (OR)
Time Frame:34 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:% subjects with adverse events (AEs)
Time Frame:34 months
Safety Issue:
Description:
Measure:% subjects with serious adverse events (SAEs)
Time Frame:34 months
Safety Issue:
Description:
Measure:% subjects with clinically significant change from baseline in clinical laboratory tests
Time Frame:34 months
Safety Issue:
Description:
Measure:% subjects with anti-drug antibodies (ADA) to treatment
Time Frame:34 months
Safety Issue:
Description:
Measure:% of subjects with neutralizing antibodies (NAb) to treatment
Time Frame:34 months
Safety Issue:
Description:
Measure:% of subjects with clinically significant changes in electrocardiogram (ECG) measurements
Time Frame:34 months
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve (AUC)
Time Frame:34 months
Safety Issue:
Description:
Measure:Maximum measured concentration in serum (Cmax)
Time Frame:34 months
Safety Issue:
Description:
Measure:Time from dosing to maximum measured concentration (tmax)
Time Frame:34 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2)
Time Frame:34 months
Safety Issue:
Description:
Measure:Total clearance of the analyte in serum (CL)
Time Frame:34 months
Safety Issue:
Description:
Measure:Apparent volume of distribution during specific time points
Time Frame:34 months
Safety Issue:
Description:
Measure:Median duration of response (DOR)
Time Frame:34 months
Safety Issue:
Description:
Measure:Disease control rate (DCR)
Time Frame:34 months
Safety Issue:
Description:
Measure:Landmark progression free survival (PFS)
Time Frame:34 months
Safety Issue:
Description:
Measure:Median PFS
Time Frame:34 months
Safety Issue:
Description:
Measure:Median overall survival (OS)
Time Frame:34 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jounce Therapeutics, Inc.

Trial Keywords

  • ICOS
  • ICOS agonist monoclonal antibody
  • JTX-2011
  • Vopratelimab
  • Anti-CTLA-4
  • Ipilimumab
  • EMERGE
  • Immunotherapy
  • Immuno-Oncology
  • Cancer
  • Non-small Cell Lung Cancer
  • Urothelial Cancer

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