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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03729245




Registration number
NCT03729245
Ethics application status
Date submitted
29/10/2018
Date registered
2/11/2018
Date last updated
11/04/2023

Titles & IDs
Public title
A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)
Scientific title
A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma
Secondary ID [1] 0 0
CA045002
Secondary ID [2] 0 0
17-214-09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Metastatic Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - bempegaldesleukin
Treatment: Drugs - sunitinib
Treatment: Other - nivolumab
Treatment: Drugs - cabozantinib

Experimental: Combination of bempegaldesleukin + nivolumab - Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.

Active comparator: sunitinib or cabozantinib - Patients in Arm B will receive the Investigator's choice of either one of two treatment options.


Treatment: Other: bempegaldesleukin
Specified dose on specified days

Treatment: Drugs: sunitinib
Specified dose on specified days

Treatment: Other: nivolumab
Specified dose on specified days

Treatment: Drugs: cabozantinib
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
Timepoint [1] 0 0
Approximately 32 months
Primary outcome [2] 0 0
Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC
Timepoint [2] 0 0
Approximately 32 months
Secondary outcome [1] 0 0
Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
Timepoint [1] 0 0
Approximately 32 months

Eligibility
Key inclusion criteria
Key

* Provide written, informed consent to participate in the study and follow the study procedures
* Karnofsky Performance Status (KPS) of at least 70%
* Measurable disease per mRECIST 1.1 criteria
* Histologically confirmed RCC with a clear-cell component (may have sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
* Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score (favorable-, intermediate-, or poor-risk) are eligible. At least one IMDC prognostic factor must be present to qualify as either intermediate- or poor-risk renal cell carcinoma.
* No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* An active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist)
* Patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist)
* Any tumor invading the wall of a major blood vessels
* Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 28 days prior to randomization
* Need for >2 medications for management of hypertension (including diuretics)
* History of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), or clinically significant thromboembolic event within 3 months of randomization

Additional protocol defined inclusion/exclusion criteria and exceptions apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2022
Sample size
Target
Accrual to date
Final
623
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Orange Cancer Centre - Orange
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [3] 0 0
Macquarie University - Sydney
Recruitment hospital [4] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [5] 0 0
Barwon Health - Parkville
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
2109 - Sydney
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
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United States of America
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Arizona
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Arkansas
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California
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Florida
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Georgia
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Louisiana
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Maryland
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Nevada
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New York
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Ohio
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Oregon
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Pennsylvania
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Texas
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United States of America
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Utah
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Argentina
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Rio Negro
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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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Argentina
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La Rioja
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Argentina
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Rosario
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Argentina
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San Miguel De Tucumán
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Argentina
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Santa Fe
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Brazil
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Bahia
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Brazil
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Minas Gerais
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Brazil
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Parana
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Brazil
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Rio Grande Do Norte
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Rio Grande Do Sul
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Santa Catarina
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Brazil
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Sao Paulo
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São Paulo
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Brazil
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Caxias Do Sul
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Brazil
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Fortaleza
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Brazil
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Lages
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Brazil
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Rio De Janeiro
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Brazil
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São José Do Rio Preto
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Chile
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Los Lagos
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Chile
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Los Rios
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Chile
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Santiago
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Chile
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Temuco
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Chile
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Viña Del Mar
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Mexico
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Distrito Federal
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Mexico
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Michoacan
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Mexico
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Nuevo León
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Mexico
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Monterrey
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Mexico
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Puebla
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New Zealand
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Auckland
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Peru
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La Lobertad
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Peru
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Lima
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kursk
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Moscow
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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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Russian Federation
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Volzhskiy
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Russian Federation
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Yaroslavl
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Singapore
State/province [59] 0 0
Singapore

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 compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).
Trial website
https://clinicaltrials.gov/study/NCT03729245
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/study/NCT03729245