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Urinary Bladder NeoplasmPhase 2PIVOT-10NCT03785925

A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

A Phase 2 study testing Bempegaldesleukin and Nivolumab in people with Urinary Bladder Neoplasm and Neoplasm Metastasis, run by Nektar Therapeutics at 70 sites in 18 countries.

Completed

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

Official record
Search all trials

Trial summary

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasm, Neoplasm Metastasis
What is being tested?
Bempegaldesleukin and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
70 sitesin 18 countries
Study dates
29 Apr 2019to 30 Jun 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provide written, informed consent to participate in the study and follow the study procedures
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Measurable disease per RECIST 1.1 criteria
  • Histologically or cytologically documented inoperable, locally advanced or metastatic urothelial cell carcinoma (also termed TCC)
  • Fresh biopsy or archival tissue
  • No prior systemic chemotherapy or investigational agent for inoperable locally advanced or mUC
  • Ineligible for cisplatin

Who cannot join

  • Patients who have an active, known or suspected autoimmune disease
  • Patients must not have received prior IL-2 therapy
  • Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte associated protein 4 (anti CTLA-4) antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Patients with hypertension must be on a stable antihypertensive regimen for the 14 days prior to Cycle 1 Day 1
  • Additional protocol-defined inclusion/exclusion criteria applied

Trial locations and contacts

70 sites in 18 countries.

70 sites in 18 countries

United States8 sites

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Laura And Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • Southeastern Regional Medical Center - CTCA - PPDS

    Newnan, Georgia, 30265

  • Investigator Site - Peoria

    Peoria, Illinois, 61615

  • San Francisco VA Medical Center - NAVREF - PPDS

    San Francisco, California, 94143

  • Innovative Clinical Research Institute, LLC

    Whittier, California, 90603

Other trials in United States

Spain8 sites

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, Catalonia, 08025

  • Hospital del Mar

    Barcelona, 08003

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050

  • Hospital Universitario Ramon y Cajal

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Argentina7 sites

  • Hospital Alemán

    Buenos Aires, C1118AAT

  • Instituto Médico Especializado Alexander Fleming

    Buenos Aires, C1426ANZ

  • Centro Médico Privado CEMAIC

    Córdoba, X5000HHW

  • Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.

    Córdoba, X5002AOQ

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000DSK

  • CAIPO Centro para la atención integral del paciente oncológico

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro de Investigación Clínica - Clínica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

France6 sites

  • Centre François Baclesse

    Caen, Calvados, 14076

  • Hôpital Privé TOULON/HYERES Sainte Marguerite

    Hyères, 83400

  • Centre Jean Bernard Clinique Victor Hugo

    Le Mans, 72015

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • Edog Ico - Ppds

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Australia5 sites

  • Monash Health, Monash Medical Centre

    Bentleigh East, Victoria, 3165

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • St John of God Murdoch Hospital

    Nedlands, Western Australia, 6009

  • Tasman Health Care

    Southport, Queensland, 4215

Other trials in Australia

Israel5 sites

  • Rambam Medical Center - PPDS

    Haifa, 31096

  • Meir Medical Center

    Kfar Saba, 44281

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 52620

  • Shamir Medical Center Assaf Harofeh

    Tsrifin, Central District, 70300

Other trials in Israel

Russia5 sites

  • Federal State Institution Medical Radiology Research Center

    Obninsk, 249036

  • Clinical Oncology Dispensary

    Omsk, 644013

  • PMI Euromedservice

    Pushkin, 196603

  • Railway Clinical Hospital JSC RZhD

    Saint Petersburg, 195271

  • Regional Clinical Oncology Hospital

    Yaroslavl, Yaroslavl Oblast, 150040

Other trials in Russia

Germany4 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

  • Kliniken Nordoberpfalz AG

    Weiden, Bavaria, 92637

Other trials in Germany

Greece4 sites

  • Alexandra Hospital

    Athens, Attica, 115 28

  • University General Hospital of Larissa

    Larissa, 41110

  • Medical Center of Athens

    Marousi, Attica, 151 25

  • Euromedica - PPDS

    Thessaloniki, 54645

Other trials in Greece

Belgium3 sites

  • Algemeen Ziekenhuis Klina

    Brasschaat, Antwerpen, 2930

  • AZ Groeninge

    Kortrijk, 8500

  • GasthuisZusters Antwerpen

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

Italy3 sites

  • Centro Di Riferimento Oncologico

    Aviano, Pordenone, 33081

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

    Meldola, Emilia-Romagna, 47014

  • Istituto Nazionale Dei Tumori

    Milan, 20133

Other trials in Italy

Turkey (Türkiye)3 sites

  • Ankara University Medical Faculty - PPDS

    Ankara, 6100

  • Izmir Medicalpark Hospital

    Izmir, 35530

  • Inonu University Faculty of Medicine Turgut Ozal Medical Center

    Malatya, 44280

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Royal Marsden Hospital - Surrey

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Mexico2 sites

  • Phylasis Clinicas Research S. de R.L. de C.V.

    Cuautitlán Izcalli, 54769

  • Health Pharma Professional Research S.A de C.V.

    Mexico City, Mexico City, 03810

Other trials in Mexico

Canada1 site

  • University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Finland1 site

  • Helsingin Yliopistollinen Keskussairaala - PPDS

    Helsinki, 00290

Other trials in Finland

Netherlands1 site

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066

Other trials in Netherlands

Portugal1 site

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra, 3000-075

Other trials in Portugal

About this study

Official title: A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

Being tested
Bempegaldesleukin, Nivolumab
Keywords
Bladder, Bladder Cancer, CD122, Cisplatin Ineligible, Immuno-oncology, Immunotherapy, Locally Advanced Urothelial Cancer, Metastatic Urothelial Cancer, mUC, Natural Killer Cells, Nivolumab, NKTR-214, Opdivo®, PD-L1, Urothelial Cancer, Urothelial, Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Bempegaldesleukin, BEMPEG
Medical subject headings
Urinary Bladder Neoplasms, Neoplasm Metastasis, Carcinoma, Transitional Cell

What participants receive

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

  • BempegaldesleukinBiological

    Also called NKTR-214, BMS-986321

    Specified dose on specified days

  • NivolumabBiological

    Also called Opdivo®, BMS-936658

    Specified dose on specified days

Study groups in NCT03785925
Study groupRoleWhat they receive
Combination of bempegaldesleukin (NKTR-214) + nivolumabExperimentalParticipants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
Receives: Biological: Bempegaldesleukin; Biological: Nivolumab

What is being measured

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

  1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

    To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in patients whose tumors have low programmed cell death ligand 1 (PD-L1) expression. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy.

    CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in All Treated Patients

    To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in all treated patients. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy.

    CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months.

  2. Duration of Response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

    To evaluate the effect of NKTR 214 in combination with nivolumab by assessing DOR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in all treated patients and patients whose tumors have low PD-L1 expression.

    DOR is defined for patients who have a confirmed Complete Response (CR) or Partial Response (PR) as the date from first documented CR or PR per RECIST 1.1 to the date of documentation of disease progression as assessed by BICR or death due to any cause, whichever is earlier. Patients who do not have disease progression or die will be censored on the date of their last evaluable tumor assessment.

    Measured: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months.

  3. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

    To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator Assessment in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression.

    ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy.

    Measured: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months.

  4. Duration of Response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

    To evaluate the effect of NKTR 214 in combination with nivolumab by assessing DOR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator Assessment in all treated patients and patients whose tumors have low PD-L1 expression.

    DOR is defined for patients who have a confirmed Complete Response (CR) or Partial Response (PR) as the date from first documented CR or PR per RECIST 1.1 to the date of documentation of disease progression as assessed by BICR or death due to any cause, whichever is earlier. Patients who do not have disease progression or die will be censored on the date of their last evaluable tumor assessment.

    Measured: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months.

Timeline

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

  1. First posted24 Dec 2018
  2. Study start29 Apr 2019
  3. Primary completion9 Feb 2022
  4. Study completion30 Jun 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03785925
Sponsor's protocol ID
18-214-10
Other IDs
CA045-012, 2018-003636-79, 2018
Acronym
PIVOT-10
Status last verified
Mar 2023
First submitted
20 Dec 2018
Last updated
28 Mar 2023
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 Bempegaldesleukin and Nivolumab in people with Urinary Bladder Neoplasm and Neoplasm Metastasis, run by Nektar Therapeutics at 70 sites in 18 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 7 inclusion and 5 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Spain, Argentina, France, Australia and 13 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?

Yes. Results are posted in the registry (first posted 28 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression (time frame: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 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 NCT03785925.

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 28 Mar 2023.

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