A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer (PIVOT-10)

March 27, 2023 updated by: Nektar Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman
      • Buenos Aires, Argentina, C1426ANZ
        • Instituto Medico Especializado Alexander Fleming
      • Córdoba, Argentina, X5000HHW
        • Centro Medico Privado CEMAIC
      • Córdoba, Argentina, X5002AOQ
        • Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
    • Rio Negro
      • Viedma, Rio Negro, Argentina, R8500ACE
        • Centro de Investigación Clínica - Clínica Viedma
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSK
        • Instituto de Oncología de Rosario
    • Tucumán
      • San Miguel De Tucumán, Tucumán, Argentina, 4000
        • CAIPO Centro para la Atencion Integral del Paciente Oncologico
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Tasman Health Care
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Adelaide Cancer Centre
    • Victoria
      • Bentleigh East, Victoria, Australia, 3165
        • Monash Health, Monash Medical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • St John of God Murdoch Hospital
  • Belgium
      • Kortrijk, Belgium, 8500
        • Az Groeninge
    • Antwerpen
      • Brasschaat, Antwerpen, Belgium, 2930
        • Algemeen Ziekenhuis klina
      • Wilrijk, Antwerpen, Belgium, 2610
        • GasthuisZusters Antwerpen
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network
  • Finland
      • Helsinki, Finland, 00290
        • Helsingin Yliopistollinen Keskussairaala - PPDS
  • France
      • Hyères, France, 83400
        • Hôpital Privé TOULON/HYERES Sainte Marguerite
      • Le Mans, France, 72015
        • Centre Jean Bernard Clinique Victor Hugo
      • Paris, France, 75908
        • Hôpital Européen Georges Pompidou
      • Saint-Herblain, France, 44805
        • Edog Ico - Ppds
      • Villejuif, France, 94805
        • Institut Gustave Roussy
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre Francois Baclesse
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
    • Baden-Württemberg
      • Nürtingen, Baden-Württemberg, Germany, 72622
        • Studienpraxis Urologie
    • Bavaria
      • Weiden, Bavaria, Germany, 92637
        • Kliniken Nordoberpfalz AG
  • Greece
      • Larissa, Greece, 41110
        • University General Hospital of Larissa
      • Thessaloníki, Greece, 54645
        • Euromedica - PPDS
    • Attiki
      • Athens, Attiki, Greece, 115 28
        • Alexandra Hospital
      • Maroúsi, Attiki, Greece, 151 25
        • Medical Center of Athens
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center - PPDS
      • Kefar Saba, Israel, 44281
        • Meir Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center - PPDS
      • Tel Aviv, Israel, 52620
        • Tel Aviv Sourasky Medical Center PPDS
    • HaMerkaz
      • Zerifin, HaMerkaz, Israel, 70300
        • Shamir Medical Center Assaf Harofeh
  • Italy
      • Milano, Italy, 20133
        • Istituto Nazionale dei Tumori
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Centro Di Riferimento Oncologico
  • Mexico
      • Cuautitlán Izcalli, Mexico, 54769
        • Phylasis Clinicas Research S. de R.L. de C.V.
    • Distrito Federal
      • Ciudad de mexico, Distrito Federal, Mexico, 03810
        • Health Pharma Professional Research S.A de C.V.
  • Netherlands
      • Amsterdam, Netherlands, 1066
        • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar E Universitario de Coimbra EPE
  • Russian Federation
      • Obninsk, Russian Federation, 249036
        • Federal State Institution Medical Radiology Research Center
      • Omsk, Russian Federation, 644013
        • Clinical Oncology Dispensary
      • Pushkin, Russian Federation, 196603
        • PMI Euromedservice
      • Saint Petersburg, Russian Federation, 195271
        • Railway Clinical Hospital JSC RZhD
    • Yaroslavskaya Oblast
      • Yaroslavl, Yaroslavskaya Oblast, Russian Federation, 150040
        • Regional Clinical Oncology Hospital
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro - CIOCC
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio - PPDS
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Catalonia
      • Barcelona, Catalonia, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Ramon y Cajal
  • Turkey
      • Ankara, Turkey, 6100
        • Ankara University Medical Faculty - PPDS
      • Malatya, Turkey, 44280
        • Inonu University Faculty of Medicine Turgut Ozal Medical Center
      • İzmir, Turkey, 35530
        • Izmir Medicalpark Hospital
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital - Surrey
  • United States
    • California
      • San Francisco, California, United States, 94143
        • San Francisco VA Medical Center - NAVREF - PPDS
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute, LLC
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
      • Newnan, Georgia, United States, 30265
        • Southeastern Regional Medical Center - CTCA - PPDS
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Investigator Site - Peoria
    • New York
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo®
  • BMS-936658
Biological: Bempegaldesleukin
Specified dose on specified days
Other Names:
  • NKTR-214
  • BMS-986321

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
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 Outcome Measures

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

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.
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.
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
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.

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.
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.
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
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.

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.
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.
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
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.

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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nektar Therapeutics

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2019

Primary Completion (Actual)

February 9, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-214-10
  • CA045-012 (Other Identifier: Bristol-Myers Squibb Protocol ID)
  • 2018-003636-79 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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