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NSCLCPhase 2SELECTNCT04549025

Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen

A Phase 2 study testing Pimivalimab and Vopratelimab in people with NSCLC, run by Jounce Therapeutics, Inc. at 72 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase 2, open-label study to evaluate PD-1 inhibitor pimivalimab (JTX-4014) alone and in combination with vopratelimab (JTX-2011), an ICOS agonist, in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum-based chemotherapy regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC
What is being tested?
Pimivalimab and Vopratelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
72 sitesin 14 countries
Study dates
19 Oct 2020to 25 Apr 2024
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

  • Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures;
  • Histologically or cytologically confirmed diagnosis of NSCLC with evaluable or measurable disease according to RECIST v1.1 with at least 1 measurable lesion;
  • Confirmed tumor RNA signature score in accordance with the study protocol;
  • Previously treated for locally advanced or metastatic NSCLC with 1 prior systemic antineoplastic platinum-containing regimen. Regimen should consist of chemotherapy or with bevacizumab;
  • Age of ≥18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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  • Predicted life expectancy of ≥ 3months;
  • Specified laboratory values in accordance with the study protocol;
  • If with medical history of the following, eligibility should be discussed with the Medical Monitor:
  • Prior biliary tract disorders (based on Medical Dictionary for Regulatory Activities [MedDRA] system organ class of Hepatobiliary disorders and MedDRA high-level terms of Obstructive bile duct disorders, Hepatic vascular disorders, and Structural and other bile duct disorders);
  • Portal hypertension and/or hepatic vascular disorders;
  • For women of childbearing potential (WOCBP): negative serum pregnancy test within 72 hours prior to planned Cycle 1, Day 1 (C1D1) and a negative urine or serum pregnancy test on C1D1. In addition, the WOCBP must be willing to complete a urine or serum pregnancy test prior to each dose of either study drug;
  • 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 that, alone or in combination, result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.

Who cannot join

  • Concurrent anticancer treatment or subject is expected to require any other form of antineoplastic therapy while on study, either approved or investigational;
  • Current or past participation in a study of an investigational agent or using an investigational device in the metastatic setting;
  • Chemotherapy <28 days prior to planned C1D1
  • Prior immunotherapy including, but not limited to PD-1 or PD-L1 inhibitor monoclonal antibody (mAb) at any time, including pimivalimab; therapy with any mAb that specifically binds to ICOS, including vopratelimab; or chimeric antigen receptor T cell therapy;
  • Organ transplantation, including allogenic or autologous stem cell transplantation;
  • Use of anticancer therapies listed below in the metastatic setting (allowed as prior treatment for localized disease):
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  • Biologic therapy
  • Targeted therapy, with the exception of bevacizumab if administered in combination with a platinum-based chemotherapy regimen as first line treatment
  • Positive test for any of the following epidermal growth factor receptor gene mutations in blood or tumor: Exon 18 G719A; Exon 18 G719C; Exon 18 G719S; Exon 19 Del; Exon 20 S768I; Exon 20 T790M; Exon 20 Ins; Exon 21 L858R; Exon 21 L861Q;
  • The following toxicity history:
  • Ongoing toxicity attributed to prior therapy that was Grade >1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE); Exceptions: Grade >1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement therapy) and are approved by the Medical Monitor;
  • History of pneumonitis or interstitial lung disease;
  • Symptomatic ascites or pleural effusion (subjects who are clinically stable for >3 months following treatment for these conditions [including therapeutic thoraco- or paracentesis] are eligible);
  • If with medical history of the following, eligibility should be discussed with the Medical Monitor: colitis, hepatitis, nephritis, skin reactions, or encephalitis;
  • Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or IV Ig preparations; any history of anaphylaxis; prior history of human anti-human antibody response; or known allergy to any of the study drugs (including their analogues or excipients [L-Histidine, mannitol, sodium chloride, or polysorbate 80]);
  • Major surgery (excluding minor procedures, e.g., placement of vascular access, gastrointestinal/biliary stent, and biopsy) < 4 weeks prior to planned C1D1;
  • Prior whole brain radiation;
  • Subjects with the following should be reviewed with the Medical Monitor prior to enrollment:
  • Brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation;
  • Radiation (other than whole brain radiation) has been or will be administered <21 days prior to planned C1D1;
  • Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis B, C, or human immunodeficiency virus (testing not required);
  • Women who are pregnant, breastfeeding, or who plan to become pregnant/breastfeed while on study; men who plan to father children during the study;
  • Concurrent second malignancy;
  • An active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents at a dose of ≥10 mg/day of prednisone equivalent. Subjects who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study. Subjects with hypothyroidism who are stable on hormone replacement therapy will not be excluded from the study;
  • Medical or social condition that, in the opinion of the Investigator, might place the subject at an increased risk, adversely affect compliance, or confound safety or other clinical study data interpretation;
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Trial locations and contacts

72 sites in 14 countries.

72 sites in 14 countries

Russia17 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk

  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

    Kazan'

  • Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

    Krasnoyarsk

  • Kursk Regional Oncology Centre

    Kursk

  • Vitamed Multidisciplinary Medical Center

    Moscow

  • Nizhniy Novgorod City Oncology Center

    Nizhny Novgorod

  • Clinical Oncology Dispensary

    Omsk

  • PMI Euromedservice

    Pushkin

  • Ryazan State Medical University n.a. I.P. Pavlov

    Ryazan

  • First St. Petersburg State Medical University n.a. I.P Pavlov

    Saint Petersburg

  • GBUZ St. Petersburg Clinical Research Center of Specialized Types of Care Oncology n.a. Napalkova

    Saint Petersburg

  • JSC "Current medical technologies"

    Saint Petersburg

  • Mordovia State University

    Saransk

  • Research Oncology Institute of Tomsk Scientific Center

    Tomsk

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd

  • Regional Clinical Oncology Hospital

    Yaroslavl

Other trials in Russia

Ukraine15 sites

  • Communal Nonprofit Enterprise Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of ChOC

    Cherkasy

  • Communal Nonprofit Enterprise City Clinical Hospital #4 of Dnipro City Council

    Dnipro

  • Municipal Nonprofit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC

    Ivano-Frankivsk

  • Arensia Kapitanivka - PPDS

    Kapitanivka

  • Communal Nonprofit Enterprise Regional Center of Oncology

    Kharkiv

  • SI Institute of Medical Radiology and Oncology n.a. S.P. Hryhoriev of NAMS of Ukraine

    Kharkiv

  • Communal Nonprofit Enterprise Khmelnytskyi Regional Antitumor Center of Khmelnytskyi Regional Council

    Khmelnytskyi

  • Private Enterprise Private Manufacturing Company Acinus

    Kropyvnytskyi

  • Clinic of National Institute of Cancer

    Kyiv

  • Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center

    Kyiv

  • Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

    Kyiv

  • Medical Center of LLC ARENSIA Exploratory Medicine

    Kyiv

  • ME Volyn Regional Clinical Hospital of the Volyn Regional Council Regional Medical Oncology Centre

    Lutsk

  • Medical and diagnostic center of MediX-Ray International Group LLC Israeli Oncology Hospital LISOD

    Obukhiv

  • MNPE Central City Clinical Hospital of Uzhhorod City Council

    Uzhhorod

Other trials in Ukraine

Turkey (Türkiye)9 sites

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana

  • Hacettepe University Medical Faculty Hospital

    Ankara

  • Akdeniz University Medical Faculty Hospital

    Antalya

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane - Hematoloji Bilim Dali

    Edirne

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    Istanbul

  • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir

  • Izmir Ekonomi University Medical Point Hospital

    Izmir

  • Inonu University Faculty of Medicine Turgut Ozal Medical Center

    Malatya

Other trials in Turkey (Türkiye)

Bulgaria5 sites

  • Multiprofile Hospital for Active Treatment - Dobrich AD

    Dobrich

  • Multiprofile Hospital for Active Treatment - Uni Hospital OOD

    Panagyurishte

  • Complex Oncology Center Plovdiv

    Plovdiv

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda

    Sofia

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia

Other trials in Bulgaria

Serbia5 sites

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade

  • Institute for Oncology and Radiology of Serbia - PPDS

    Belgrade

  • University Clinical Center of Serbia - PPDS

    Belgrade

  • Institute of Lung Diseases Vojvodina

    Kamenitz

  • University Clinical Center Kragujevac

    Kragujevac

Other trials in Serbia

Croatia4 sites

  • Clinical Hospital Centre Osijek

    Osijek

  • General Hospital Pula

    Pula

  • University Hospital of Split

    Split

  • Klinicki bolnicki centar Zagreb

    Zagreb

Other trials in Croatia

Romania4 sites

  • Affidea Romania SRL

    Bucharest

  • Prof Dr I Chiricuta Institute of Oncology

    Cluj-Napoca

  • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

    Constanța

  • Oncology Center Sfantul Nectarie

    Craiova

Other trials in Romania

Hungary3 sites

  • Veszprem Megyei Tudogyogyintezet

    Farkasgyepű

  • Bács-Kiskun Varmegyei Oktatokorhaz

    Kecskemét

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár

Other trials in Hungary

Belarus2 sites

  • Minsk City Clinical Oncology Dispensary

    Minsk

  • N. N. Alexandrov National Cancer Centre

    Minsk

Other trials in Belarus

Bosnia and Herzegovina2 sites

  • University Clinical Center of the Republic of Srpska

    Banja Luka

  • Clinical Center University of Sarajevo

    Sarajevo

Other trials in Bosnia and Herzegovina

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga

  • Riga East Clinical University Hospital, Latvian Oncology Center

    Riga

Other trials in Latvia

Slovakia2 sites

  • Narodny onkologicky - PPDS

    Bratislava

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice

Other trials in Slovakia

Georgia1 site

  • Arensia Tbilisi - PPDS

    Tbilisi

Other trials in Georgia

Moldova1 site

  • Arensia Chisinau - PPDS

    Chisinau

Other trials in Moldova

About this study

Official title: Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen

This is a Phase 2, open-label study to evaluate PD-1 inhibitor pimivalimab (JTX-4014) alone and in combination with vopratelimab (JTX-2011), an ICOS agonist, in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum-based chemotherapy regimen.

Read the detailed description

Pimivalimab is a fully human IgG4 monoclonal antibody designed to specifically bind to programmed cell death receptor protein-1 (PD-1) and block its interaction with its ligands, programmed cell death receptor protein-1 ligand 1 (PD-L1) and programmed cell death receptor protein-1 ligand 2 (PD-L2), to augment anti-tumor T cell activity. 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 efficacy, safety, tolerability of pimivalimab alone and in combination with vopratelimab in biomarker-selected adult subjects with metastatic non-small cell lung cancer (NSCLC) who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum-based chemotherapy regimen.

Conditions
NSCLC
Being tested
Pimivalimab, Vopratelimab

What participants receive

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

  • PimivalimabDrug

    Also called JTX-4014

    Specified dose on specified days

  • VopratelimabDrug

    Also called JTX-2011

    Specified dose on specified days

Study groups in NCT04549025
Study groupRoleWhat they receive
Monotherapy Cohort 1 (MC1)ExperimentalEnrolled patients will receive 1000 mg pimivalimab (JTX-4014) administered alone every 6 weeks (q6w).
Receives: Drug: Pimivalimab
Combination Therapy Cohort 1 (CC1)ExperimentalFor Cycle 1, enrolled patients will receive 0.1 mg/kg vopratelimab (JTX-2011) on Day 1, followed by 1000 mg pimivalimab (JTX-4014) on Day 8. For Cycle 2 and beyond, vopratelimab and pimivalimab will be administered in combination (on Day 1) q6w.
Receives: Drug: Pimivalimab; Drug: Vopratelimab
Combination Therapy Cohort 2 (CC2)ExperimentalFor Cycle 1, enrolled patients will receive 0.03 mg/kg vopratelimab (JTX-2011) on Day 1, followed by 1000 mg pimivalimab (JTX-4014) on Day 8. For Cycle 2 and beyond, vopratelimab and pimivalimab will be administered in combination (on Day 1) q6w.
Receives: Drug: Pimivalimab; Drug: Vopratelimab

What is being measured

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

  1. Change in measurable lesion size

    Mean percent change from baseline tumor size of all measurable existing and new lesions

    Measured: over 9 and 18 weeks (average)

Secondary outcomes (16)

  1. Overall response rate (ORR)

    ORR (percentage of subjects with complete response [CR] + partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: up to 24 months

  2. Progression-free survival (PFS)

    PFS according to RECIST v1.1

    Measured: up to 24 months

  3. Landmark PFS rate

    Landmark PFS rate at 9 months according to RECIST v1.1

    Measured: 9 months

  4. Disease control rate (DCR)

    DCR (confirmed CR + confirmed PR + unconfirmed stable disease [SD]) according to RECIST v1.1

    Measured: up to 24 months

  5. Duration of response (DOR)

    DOR in months according to RECIST v1.1

    Measured: up to 24 months

  6. Overall survival (OS)

    Measured: up to 24 months

  7. Treatment-emergent adverse events (TEAEs)

    Incidence and grade of TEAEs

    Measured: up to 24 months

  8. Pharmacokinetic properties of pimivalimab and vopratelimab - Cmax (maximum observed concentration)

    Measured: Cycle 1 through Cycle 6 (each cycle is 6 weeks)

  9. Pharmacokinetic properties of pimivalimab and vopratelimab - Tmax (time of first occurrence of Cmax)

    Measured: Cycle 1 through Cycle 6 (each cycle is 6 weeks)

  10. Pharmacokinetic properties of pimivalimab and vopratelimab - AUClast (area under the concentration-time curve from time zero to the last measurable concentration)

    Measured: Cycle 1 through Cycle 6 (each cycle is 6 weeks)

  11. Pharmacokinetic properties of pimivalimab and vopratelimab - half-life (time it takes for the concentration of the drug in the plasma or the total amount in the body to be reduced by 50%)

    Measured: Cycle 1 through Cycle 6 (each cycle is 6 weeks)

  12. Pharmacokinetic properties of pimivalimab and vopratelimab - clearance (efficiency of drug elimination)

    Measured: Cycle 1 through Cycle 6 (each cycle is 6 weeks)

  13. Pharmacokinetic properties of pimivalimab and vopratelimab - volume of distribution (amount of drug in the body divided by the plasma drug concentration)

    Measured: Cycle 1 through Cycle 6 (each cycle is 6 weeks)

  14. Incidence of anti-drug antibodies (ADAs) to either pimivalimab or vopratelimab

    Measured: Cycle 1 through Cycle 6 (each cycle is 6 weeks)

  15. Incidence of neutralizing antibodies (NAbs) to either pimivalimab or vopratelimab

    Measured: Cycle 1 through Cycle 6 (each cycle is 6 weeks)

  16. Association of baseline tumor RNA signature score with clinical outcomes

    Change in measurable lesion size for patients with elevated tumor RNA signature score (i.e., tumor inflammation signature (TIS) vopra score ≥ 7.9)

    Measured: up to 24 months

Timeline

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

  1. First posted16 Sep 2020
  2. Study start19 Oct 2020
  3. Primary completion25 Apr 2024
  4. Study completion25 Apr 2024

Why it stopped: The Sponsor decided to discontinue development of pimivalimab prior to the planned study completion. At the time of the decision to discontinue development, enrollment in the study had been completed.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549025
Sponsor's protocol ID
JTX-4014-202
Acronym
SELECT
Status last verified
May 2024
First submitted
1 Sep 2020
Last updated
22 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pimivalimab and Vopratelimab in people with NSCLC, run by Jounce Therapeutics, Inc. at 72 sites in 14 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 13 inclusion and 26 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: stopped early, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Russia, Ukraine, Turkey (Türkiye), Bulgaria, Serbia and 9 more countries. 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 was stopped early (reason given: The Sponsor decided to discontinue development of pimivalimab prior to the planned study completion. At the time of the decision to discontinue development, enrollment in the study had been completed.). Results are not available in the source record.

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?

Change in measurable lesion size (time frame: over 9 and 18 weeks (average)). 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 NCT04549025.

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 22 May 2024.

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