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CancerPhase 2EMERGENCT03989362

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

A Phase 2 study testing Vopratelimab and Ipilimumab in people with Cancer, run by Jounce Therapeutics, Inc. at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Vopratelimab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
21 sitesin 2 countries
Study dates
6 Jun 2019to 15 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Male or female ≥ 18 years of age
  • 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
  • Prior treatment with a PD-1/PD -L1 inhibitor for at least 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Predicted life expectancy ≥ 3 months
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  • Have laboratory values in accordance with the study protocol
  • 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
  • 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
  • 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.

Who cannot join

  • Concurrent anticancer treatment (either approved or investigational, excluding radiation therapy)
  • 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:
  • Biologic therapy, including immunotherapy, within 21 days prior to C1D1
  • Chemotherapy within 21 days (42 days for mitomycin or nitrosoureas) prior to C1D1
  • Anti-CTLA-4 or anti-ICOS therapy at any time
  • Chimeric antigen receptor T-cell therapy at any time
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  • Organ transplantation, including allogeneic or autologous stem-cell transplantation, at any time
  • Major surgery (excluding minor procedures, e.g., placement of vascular access, biopsy, etc.) within 4 weeks prior to C1D1
  • Live vaccines within 30 days prior to C1D1 (inactivated vaccines are allowed; seasonal vaccines should be up to date prior to C1D1)
  • 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
  • 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
  • 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
  • Brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
  • Prior whole brain radiation
  • 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
  • Active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)
  • Women who are pregnant or breastfeeding
  • History of symptomatic cardiac disease that is unresponsive to surgical or medical management
  • 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.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States18 sites

  • University of Maryland - Marlene and Stewart Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southeastern Medical Oncology Center

    Clinton, North Carolina, 28328

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Southern California Medical Center

    Los Angeles, California, 90033

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medical College

    New York, New York, 10065

  • Christiana Care Health Services

    Newark, Delaware, 19713

  • Allegheny Health Network Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • University of Rochester

    Rochester, New York, 14642

  • University of The Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Florida Cancer Specialists Sarasota Cattlemen

    Sarasota, Florida, 34232

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Canada3 sites

  • The Research Institute of the McGill University Health

    Montreal, Quebec, H4A 3J1

  • University Institute of Cardiology and Respirology of Quebec

    Québec, G1V 4G5

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

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.

Conditions
Cancer
Being tested
Vopratelimab, Ipilimumab
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
Medical subject headings
Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VopratelimabDrug

    Also called JTX-2011

    Specified dose on specified days

  • IpilimumabDrug

    Also called Yervoy

    Specified dose on specified days

Study groups in NCT03989362
Study groupRoleWhat they receive
LM1ExperimentalPhase 2 study of vopratelimab by intravenous (IV) infusion administered in combination with ipilimumab by IV infusion in NSCLC
Receives: Drug: Vopratelimab; Drug: Ipilimumab
LT1ExperimentalPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in NSCLC
Receives: Drug: Vopratelimab; Drug: Ipilimumab
UM1ExperimentalPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
Receives: Drug: Vopratelimab; Drug: Ipilimumab
UT1ExperimentalPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
Receives: Drug: Vopratelimab; Drug: Ipilimumab
LM2ExperimentalPhase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in NSCLC
Receives: Drug: Vopratelimab; Drug: Ipilimumab
LT2ExperimentalPhase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in NSCLC
Receives: Drug: Vopratelimab; Drug: Ipilimumab
UM2ExperimentalPhase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in urothelial cancer
Receives: Drug: Vopratelimab; Drug: Ipilimumab
UT2ExperimentalPhase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in urothelial cancer
Receives: Drug: Vopratelimab; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % subjects with overall response (OR)

    Measured: 34 months

Secondary outcomes (13)

  1. % subjects with adverse events (AEs)

    Measured: 34 months

  2. % subjects with serious adverse events (SAEs)

    Measured: 34 months

  3. % subjects with clinically significant change from baseline in clinical laboratory tests

    Measured: 34 months

  4. % subjects with anti-drug antibodies (ADA) to treatment

    Measured: 34 months

  5. % of subjects with neutralizing antibodies (NAb) to treatment

    Measured: 34 months

  6. % of subjects with clinically significant changes in electrocardiogram (ECG) measurements

    Measured: 34 months

  7. Percent change in target lesions from baseline

    Measured: 34 months

  8. Apparent volume of distribution during specific time points

    Measured: 34 months

  9. Median duration of response (DOR)

    Measured: 34 months

  10. Disease control rate (DCR)

    Measured: 34 months

  11. Landmark progression free survival (PFS)

    Measured: 34 months

  12. Median PFS

    Measured: 34 months

  13. Median overall survival (OS)

    Measured: 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start6 Jun 2019
  3. Primary completion15 Mar 2022
  4. Study completion15 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989362
Sponsor's protocol ID
JTX-2011-201
Acronym
EMERGE
Status last verified
Apr 2022
First submitted
13 Jun 2019
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vopratelimab and Ipilimumab in people with Cancer, run by Jounce Therapeutics, Inc. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% subjects with overall response (OR) (time frame: 34 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.

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