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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03785925




Registration number
NCT03785925
Ethics application status
Date submitted
20/12/2018
Date registered
24/12/2018
Date last updated
28/03/2023

Titles & IDs
Public title
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Scientific 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
Secondary ID [1] 0 0
CA045-012
Secondary ID [2] 0 0
18-214-10
Universal Trial Number (UTN)
Trial acronym
PIVOT-10
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasm 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Bempegaldesleukin
Other interventions - Nivolumab

Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab - Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.


Other interventions: Bempegaldesleukin
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
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 [1] 0 0
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in All Treated Patients
Timepoint [1] 0 0
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 [2] 0 0
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
Timepoint [2] 0 0
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 [3] 0 0
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
Timepoint [3] 0 0
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 [4] 0 0
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
Timepoint [4] 0 0
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.

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Tasman Health Care - Southport
Recruitment hospital [3] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [4] 0 0
Monash Health, Monash Medical Centre - Bentleigh East
Recruitment hospital [5] 0 0
St John of God Murdoch Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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United States of America
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Colorado
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Georgia
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United States of America
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Illinois
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United States of America
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New York
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United States of America
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Texas
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Argentina
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Rio Negro
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Argentina
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Santa Fe
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Argentina
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Tucumán
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Belgium
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Antwerpen
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Belgium
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Kortrijk
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Canada
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Ontario
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Finland
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Helsinki
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France
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Calvados
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France
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Hyères
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France
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Le Mans
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France
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Paris
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France
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Saint-Herblain
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France
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Villejuif
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Germany
State/province [22] 0 0
Baden-Württemberg
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Germany
State/province [23] 0 0
Bavaria
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Germany
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Berlin
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Germany
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Dresden
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Greece
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Attiki
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Greece
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Larissa
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Greece
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Thessaloníki
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Israel
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HaMerkaz
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Israel
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Haifa
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Israel
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Kefar Saba
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Emilia-Romagna
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Italy
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Pordenone
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Italy
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Milano
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Mexico
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Distrito Federal
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Mexico
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Cuautitlán Izcalli
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Netherlands
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Amsterdam
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Portugal
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Coimbra
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Russian Federation
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Yaroslavskaya Oblast
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Russian Federation
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Obninsk
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Russian Federation
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Omsk
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Russian Federation
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Pushkin
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Russian Federation
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Saint Petersburg
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Spain
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Alicante
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Spain
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Catalonia
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Madrid
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Barcelona
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Spain
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Sevilla
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Spain
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Valencia
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Turkey
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Ankara
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Turkey
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Izmir
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Turkey
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Malatya
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United Kingdom
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Surrey
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United Kingdom
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Leicester
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nektar Therapeutics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03785925
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Nektar Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03785925