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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03785925
Ethics application status
Date submitted
20/12/2018
Date registered
24/12/2018

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
Treatment: Other - Bempegaldesleukin
Treatment: Other - Nivolumab

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


Treatment: Other: Bempegaldesleukin
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
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
NA
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
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Rio Negro
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Argentina
State/province [9] 0 0
Tucumán
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
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Argentina
State/province [11] 0 0
Córdoba
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Belgium
State/province [12] 0 0
Antwerpen
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Belgium
State/province [13] 0 0
Kortrijk
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Finland
State/province [15] 0 0
Helsinki
Country [16] 0 0
France
State/province [16] 0 0
Calvados
Country [17] 0 0
France
State/province [17] 0 0
Hyères
Country [18] 0 0
France
State/province [18] 0 0
Le Mans
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Saint-Herblain
Country [21] 0 0
France
State/province [21] 0 0
Villejuif
Country [22] 0 0
Germany
State/province [22] 0 0
Baden-Württemberg
Country [23] 0 0
Germany
State/province [23] 0 0
Bavaria
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Dresden
Country [26] 0 0
Greece
State/province [26] 0 0
Attiki
Country [27] 0 0
Greece
State/province [27] 0 0
Larissa
Country [28] 0 0
Greece
State/province [28] 0 0
Thessaloníki
Country [29] 0 0
Israel
State/province [29] 0 0
HaMerkaz
Country [30] 0 0
Israel
State/province [30] 0 0
Haifa
Country [31] 0 0
Israel
State/province [31] 0 0
Kefar Saba
Country [32] 0 0
Israel
State/province [32] 0 0
Ramat Gan
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Aviv
Country [34] 0 0
Italy
State/province [34] 0 0
Emilia-Romagna
Country [35] 0 0
Italy
State/province [35] 0 0
Pordenone
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Mexico
State/province [37] 0 0
Distrito Federal
Country [38] 0 0
Mexico
State/province [38] 0 0
Cuautitlán Izcalli
Country [39] 0 0
Netherlands
State/province [39] 0 0
Amsterdam
Country [40] 0 0
Portugal
State/province [40] 0 0
Coimbra
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Yaroslavskaya Oblast
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Obninsk
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Omsk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Pushkin
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Saint Petersburg
Country [46] 0 0
Spain
State/province [46] 0 0
Alicante
Country [47] 0 0
Spain
State/province [47] 0 0
Catalonia
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia
Country [52] 0 0
Turkey
State/province [52] 0 0
Ankara
Country [53] 0 0
Turkey
State/province [53] 0 0
Izmir
Country [54] 0 0
Turkey
State/province [54] 0 0
Malatya
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Surrey
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Leicester
Country [57] 0 0
United Kingdom
State/province [57] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03785925