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

Primary Purpose

Urinary Bladder Neoplasm, Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bempegaldesleukin
Nivolumab
Sponsored by
Nektar Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasm focused on measuring 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, CPI Combination, IL-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 will apply

Sites / Locations

  • San Francisco VA Medical Center - NAVREF - PPDS
  • Innovative Clinical Research Institute, LLC
  • Rocky Mountain Cancer Centers
  • Winship Cancer Institute, Emory University
  • Southeastern Regional Medical Center - CTCA - PPDS
  • Investigator Site - Peoria
  • Laura And Isaac Perlmutter Cancer Center
  • MD Anderson Cancer Center
  • Centro de Investigación Clínica - Clínica Viedma
  • Instituto de Oncologia de Rosario
  • CAIPO Centro para la atención integral del paciente oncológico
  • Hospital Alemán
  • Instituto Médico Especializado Alexander Fleming
  • Centro Médico Privado CEMAIC
  • Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
  • St Vincent's Hospital Sydney
  • Tasman Health Care
  • Adelaide Cancer Centre
  • Monash Health, Monash Medical Centre
  • St John of God Murdoch Hospital
  • Algemeen Ziekenhuis Klina
  • GasthuisZusters Antwerpen
  • AZ Groeninge
  • University Health Network
  • Helsingin Yliopistollinen Keskussairaala - PPDS
  • Centre François Baclesse
  • Hôpital Privé TOULON/HYERES Sainte Marguerite
  • Centre Jean Bernard Clinique Victor Hugo
  • Hôpital Européen Georges Pompidou
  • Edog Ico - Ppds
  • Institut Gustave Roussy
  • Studienpraxis Urologie
  • Kliniken Nordoberpfalz AG
  • Charité - Universitätsmedizin Berlin
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden
  • Alexandra Hospital
  • Medical Center of Athens
  • University General Hospital of Larissa
  • Euromedica - PPDS
  • Shamir Medical Center Assaf Harofeh
  • Rambam Medical Center - PPDS
  • Meir Medical Center
  • Sheba Medical Center - PPDS
  • Tel Aviv Sourasky Medical Center PPDS
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
  • Centro Di Riferimento Oncologico
  • Istituto Nazionale Dei Tumori
  • Health Pharma Professional Research S.A de C.V.
  • Phylasis Clinicas Research S. de R.L. de C.V.
  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • Centro Hospitalar E Universitário de Coimbra EPE
  • Regional Clinical Oncology Hospital
  • Federal State Institution Medical Radiology Research Center
  • Clinical Oncology Dispensary
  • PMI Euromedservice
  • Railway Clinical Hospital JSC RZhD
  • Hospital General Universitario de Elche
  • Hospital de La Santa Creu i Sant Pau
  • Hospital Universitario Ramon y Cajal
  • Hospital del Mar
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario HM Sanchinarro - CIOCC
  • Hospital Universitario Virgen del Rocio - PPDS
  • Fundacion Instituto Valenciano de Oncologia
  • Ankara University Medical Faculty - PPDS
  • Izmir Medicalpark Hospital
  • Inonu University Faculty of Medicine Turgut Ozal Medical Center
  • Royal Marsden Hospital - Surrey
  • Leicester Royal Infirmary
  • Barts Health NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination of bempegaldesleukin (NKTR-214) + nivolumab

Arm Description

Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 20, 2018
Last Updated
March 27, 2023
Sponsor
Nektar Therapeutics
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03785925
Brief Title
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Acronym
PIVOT-10
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nektar Therapeutics
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasm, Neoplasm Metastasis
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, CPI Combination, IL-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination of bempegaldesleukin (NKTR-214) + nivolumab
Arm Type
Experimental
Arm Description
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
Intervention Type
Biological
Intervention Name(s)
Bempegaldesleukin
Other Intervention Name(s)
NKTR-214, BMS-986321
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo®, BMS-936658
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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
Description
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.
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
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in All Treated Patients
Description
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.
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.
Title
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
Description
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.
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.
Title
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
Description
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.
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.
Title
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
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Nektar Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
San Francisco VA Medical Center - NAVREF - PPDS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Innovative Clinical Research Institute, LLC
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Southeastern Regional Medical Center - CTCA - PPDS
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Investigator Site - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Laura And Isaac Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centro de Investigación Clínica - Clínica Viedma
City
Viedma
State/Province
Rio Negro
ZIP/Postal Code
R8500ACE
Country
Argentina
Facility Name
Instituto de Oncologia de Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSK
Country
Argentina
Facility Name
CAIPO Centro para la atención integral del paciente oncológico
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Hospital Alemán
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Instituto Médico Especializado Alexander Fleming
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Centro Médico Privado CEMAIC
City
Córdoba
ZIP/Postal Code
X5000HHW
Country
Argentina
Facility Name
Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
City
Córdoba
ZIP/Postal Code
X5002AOQ
Country
Argentina
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Tasman Health Care
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Adelaide Cancer Centre
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Monash Health, Monash Medical Centre
City
Bentleigh East
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
St John of God Murdoch Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Algemeen Ziekenhuis Klina
City
Brasschaat
State/Province
Antwerpen
ZIP/Postal Code
2930
Country
Belgium
Facility Name
GasthuisZusters Antwerpen
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Helsingin Yliopistollinen Keskussairaala - PPDS
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Centre François Baclesse
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Hôpital Privé TOULON/HYERES Sainte Marguerite
City
Hyères
ZIP/Postal Code
83400
Country
France
Facility Name
Centre Jean Bernard Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Edog Ico - Ppds
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Studienpraxis Urologie
City
Nürtingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72622
Country
Germany
Facility Name
Kliniken Nordoberpfalz AG
City
Weiden
State/Province
Bavaria
ZIP/Postal Code
92637
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Alexandra Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Medical Center of Athens
City
Maroúsi
State/Province
Attiki
ZIP/Postal Code
151 25
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Euromedica - PPDS
City
Thessaloníki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Shamir Medical Center Assaf Harofeh
City
Zerifin
State/Province
HaMerkaz
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Medical Center - PPDS
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Meir Medical Center
City
Kefar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Sheba Medical Center - PPDS
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center PPDS
City
Tel Aviv
ZIP/Postal Code
52620
Country
Israel
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Centro Di Riferimento Oncologico
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Istituto Nazionale Dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Health Pharma Professional Research S.A de C.V.
City
Ciudad de mexico
State/Province
Distrito Federal
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Phylasis Clinicas Research S. de R.L. de C.V.
City
Cuautitlán Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066
Country
Netherlands
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Federal State Institution Medical Radiology Research Center
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
PMI Euromedservice
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Railway Clinical Hospital JSC RZhD
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro - CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Fundacion Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Ankara University Medical Faculty - PPDS
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Izmir Medicalpark Hospital
City
İzmir
ZIP/Postal Code
35530
Country
Turkey
Facility Name
Inonu University Faculty of Medicine Turgut Ozal Medical Center
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Royal Marsden Hospital - Surrey
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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