A Study of NKTR-214 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)

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ClinicalTrials.gov Identifier: NCT03729245

Recruitment Status : Recruiting

First Posted : November 2, 2018

Last Update Posted : October 17, 2019

See Contacts and Locations

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

Nektar Therapeutics

Tracking Information

First Submitted Date ^ICMJE

October 29, 2018

First Posted Date ^ICMJE

November 2, 2018

Last Update Posted Date

October 17, 2019

Actual Study Start Date ^ICMJE

December 18, 2018

Estimated Primary Completion Date

December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk patients [ Time Frame: Approximately 32 months ]
ORR per RECIST 1.1 by BICR in IMDC all-risk patients [ Time Frame: Approximately 32 months ]
Overall survival (OS) in IMDC intermediate- or poor-risk patients [ Time Frame: 32-59 months ]
OS in IMDC all-risk patients [ Time Frame: 32-59 months ]

Original Primary Outcome Measures ^ICMJE

Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Approximately 2 years ]
Overall survival (OS) [ Time Frame: 27-48 months ]

Change History

Complete list of historical versions of study NCT03729245 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression-free survival (PFS) by BICR in IMDC intermediate- or poor-risk patients [ Time Frame: 32-59 months ]
PFS by BICR in IMDC all risk-patients [ Time Frame: 32-59 months ]
Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 5 years ]
ORR using RECIST 1.1 by investigator and in biomarker population [ Time Frame: 32-59 months ]
PFS by investigator and in biomarker population [ Time Frame: 32-59 months ]
OS in biomarker population [ Time Frame: 32-59 months ]
Changes in cancer-related symptoms and quality-of-life in patients using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN/FACT) Symptom Index for Kidney Cancer (FKSI-19) [ Time Frame: 32-59 months ]

Original Secondary Outcome Measures ^ICMJE

Progression-free survival (PFS) by BICR [ Time Frame: 27-48 months ]
Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 5 years ]
ORR using RECIST 1.1 by investigator and in biomarker population [ Time Frame: 27-48 months ]
PFS by investigator and in biomarker population [ Time Frame: 27-48 months ]
OS in biomarker population [ Time Frame: 27-48 months ]
Changes in cancer-related symptoms and quality-of-life in patients using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN/FACT) Symptom Index for Kidney Cancer (FKSI-19) [ Time Frame: 27-48 months ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of NKTR-214 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)

Official Title ^ICMJE

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

Brief Summary

The main purpose of this study is to compare the overall response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214) 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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma

Intervention ^ICMJE

Biological: Bempegaldesleukin
Specified dose on specified days
Other Names:
- NKTR-214
- BMS-986321
Drug: Sunitinib
Specified dose on specified days

Other Name: Sutent®
Biological: Nivolumab
Specified dose on specified days
Other Names:
- Opdivo®
- BMS-936558
Drug: Cabozantinib
Specified dose on specified days

Other Name: Cabometyx®

Study Arms ^ICMJE

Experimental: Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
Patients in Arm A will receive Bempegaldesleukin in combination with Nivolumab.
Interventions:
- Biological: Bempegaldesleukin
- Biological: Nivolumab
Active Comparator: Sunitinib or Cabozantinib
Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
Interventions:
- Drug: Sunitinib
- Drug: Cabozantinib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

June 2024

Estimated Primary Completion Date

December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key Inclusion Criteria:

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 RECIST 1.1 criteria
Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with clear cell component including patients who may have sarcomatoid features
Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score are eligible, whether favorable-, intermediate-, or poor-risk. 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
Patients with stable brain metastases following local treatment may be enrolled if certain criteria are met
Tumor tissue (archival or fresh biopsy) identified and available

Key Exclusion Criteria:

Patients who have an active, known or suspected autoimmune disease (exceptions exist)
Patients who have a known additional malignancy that is progressing or requires active treatment
Any tumor invading the inferior or superior vena cava (SVC) or other major blood vessels
Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 30 days prior to randomization
Need for >2 antihypertensive classes of agents for management of hypertension (including diuretics)

Additional protocol defined inclusion/exclusion criteria and exceptions apply

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Nektar Recruitment

855-482-8676

StudyInquiry@nektar.com

Listed Location Countries ^ICMJE

Argentina, Australia, Brazil, Chile, China, Colombia, Hong Kong, Mexico, New Zealand, Peru, Russian Federation, Singapore, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03729245

Other Study ID Numbers ^ICMJE

17-214-09
CA045002 ( Other Identifier: Bristol-Myers Squibb )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Undecided

Responsible Party

Nektar Therapeutics

Study Sponsor ^ICMJE

Nektar Therapeutics

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

Study Director:

Bridget O'Keeffe

Nektar Therapeutics

PRS Account

Nektar Therapeutics

Verification Date

October 2019

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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