Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - bempegaldesleukin
Treatment: Drugs - sunitinib
Other interventions - 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.


Other interventions: bempegaldesleukin
Specified dose on specified days

Treatment: Drugs: sunitinib
Specified dose on specified days

Other interventions: nivolumab
Specified dose on specified days

Treatment: Drugs: cabozantinib
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
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
Terminated
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
Argentina
State/province [16] 0 0
Rio Negro
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Córdoba
Country [19] 0 0
Argentina
State/province [19] 0 0
La Rioja
Country [20] 0 0
Argentina
State/province [20] 0 0
Rosario
Country [21] 0 0
Argentina
State/province [21] 0 0
San Miguel De Tucumán
Country [22] 0 0
Argentina
State/province [22] 0 0
Santa Fe
Country [23] 0 0
Brazil
State/province [23] 0 0
Bahia
Country [24] 0 0
Brazil
State/province [24] 0 0
Minas Gerais
Country [25] 0 0
Brazil
State/province [25] 0 0
Parana
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio Grande Do Norte
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio Grande Do Sul
Country [28] 0 0
Brazil
State/province [28] 0 0
Santa Catarina
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Brazil
State/province [30] 0 0
São Paulo
Country [31] 0 0
Brazil
State/province [31] 0 0
Caxias Do Sul
Country [32] 0 0
Brazil
State/province [32] 0 0
Fortaleza
Country [33] 0 0
Brazil
State/province [33] 0 0
Lages
Country [34] 0 0
Brazil
State/province [34] 0 0
Rio De Janeiro
Country [35] 0 0
Brazil
State/province [35] 0 0
São José Do Rio Preto
Country [36] 0 0
Chile
State/province [36] 0 0
Los Lagos
Country [37] 0 0
Chile
State/province [37] 0 0
Los Rios
Country [38] 0 0
Chile
State/province [38] 0 0
Santiago
Country [39] 0 0
Chile
State/province [39] 0 0
Temuco
Country [40] 0 0
Chile
State/province [40] 0 0
Viña Del Mar
Country [41] 0 0
Mexico
State/province [41] 0 0
Distrito Federal
Country [42] 0 0
Mexico
State/province [42] 0 0
Michoacan
Country [43] 0 0
Mexico
State/province [43] 0 0
Nuevo León
Country [44] 0 0
Mexico
State/province [44] 0 0
Monterrey
Country [45] 0 0
Mexico
State/province [45] 0 0
Puebla
Country [46] 0 0
New Zealand
State/province [46] 0 0
Auckland
Country [47] 0 0
Peru
State/province [47] 0 0
La Lobertad
Country [48] 0 0
Peru
State/province [48] 0 0
Lima
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Barnaul
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Chelyabinsk
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Kursk
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Moscow
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Obninsk
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Omsk
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Pushkin
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saint Petersburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Volzhskiy
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Yaroslavl
Country [59] 0 0
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/ct2/show/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/ct2/show/NCT03729245