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History of Changes for Study: NCT03729245
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)
Latest version (submitted March 31, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 31, 2018 None (earliest Version on record)
2 December 20, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 February 4, 2019 Study Status and Contacts/Locations
4 March 11, 2019 Contacts/Locations and Study Status
5 March 20, 2019 Contacts/Locations and Study Status
6 April 8, 2019 Study Status and Contacts/Locations
7 April 12, 2019 Contacts/Locations and Study Status
8 May 9, 2019 Contacts/Locations and Study Status
9 June 6, 2019 Contacts/Locations and Study Status
10 July 9, 2019 Contacts/Locations and Study Status
11 August 2, 2019 Contacts/Locations and Study Status
12 September 3, 2019 Outcome Measures, Arms and Interventions, Contacts/Locations, Study Status, Eligibility, Conditions and Study Description
13 September 20, 2019 Contacts/Locations and Study Status
14 October 15, 2019 Contacts/Locations and Study Status
15 November 15, 2019 Contacts/Locations and Study Status
16 December 16, 2019 Contacts/Locations and Study Status
17 January 10, 2020 Contacts/Locations and Study Status
18 February 7, 2020 Contacts/Locations and Study Status
19 March 6, 2020 Contacts/Locations and Study Status
20 April 7, 2020 Contacts/Locations and Study Status
21 May 4, 2020 Arms and Interventions, Outcome Measures, Study Status, Study Identification, Contacts/Locations, Eligibility, Conditions and Study Description
22 May 27, 2020 Contacts/Locations and Study Status
23 June 30, 2020 Study Status and Contacts/Locations
24 July 28, 2020 Study Status and Contacts/Locations
25 August 6, 2020 Study Status and Contacts/Locations
26 August 31, 2020 Contacts/Locations and Study Status
27 September 28, 2020 Contacts/Locations and Study Status
28 October 27, 2020 Study Status and Contacts/Locations
29 December 1, 2020 Contacts/Locations and Study Status
30 December 22, 2020 Contacts/Locations and Study Status
31 January 20, 2021 Study Status
32 February 12, 2021 Recruitment Status, Contacts/Locations and Study Status
33 March 3, 2021 Study Design and Study Status
34 April 19, 2021 Study Status and Contacts/Locations
35 May 20, 2021 Study Status
36 June 25, 2021 Study Status
37 July 28, 2021 Contacts/Locations and Study Status
38 August 24, 2021 Study Status
39 September 28, 2021 Study Status
40 October 5, 2021 Study Status and Contacts/Locations
41 November 23, 2021 Outcome Measures, Study Status, Contacts/Locations and Eligibility
42 December 15, 2021 Study Status
43 February 1, 2022 Study Status
44 February 28, 2022 Study Status
45 March 31, 2022 Study Status
Comparison Format:

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Study NCT03729245
Submitted Date:  October 31, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 17-214-09
Brief Title: 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: 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 IDs: CA045002 [Bristol-Myers Squibb]
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Not yet recruiting
Study Start: December 2018
Primary Completion: December 2021 [Anticipated]
Study Completion: June 2024 [Anticipated]
First Submitted: October 29, 2018
First Submitted that
Met QC Criteria:
October 31, 2018
First Posted: November 2, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 31, 2018
Last Update Posted: November 2, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Nektar Therapeutics
Responsible Party: Sponsor
Collaborators: Bristol-Myers Squibb
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The main purpose of this study is to compare the overall response rate (ORR) and overall survival (OS) of NKTR-214 combined with nivolumab to that of a tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma (RCC).
Detailed Description:
Open or close this module Conditions
Conditions: Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Keywords: Kidney Cancer
Kidney Neoplasms
Renal Cancer
Renal Neoplasms
CD122
CD122-Biased Agonist
CD122-Biased Cytokine
IL-2 Receptor Agonist
Immuno-oncology
Immunotherapy
NKTR-214
Nivolumab
Opdivo®
PD-L1
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Combination of NKTR-214 + Nivolumab
Participants in Arm A will receive NKTR-214 in combination with Nivolumab.
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • CD122-Biased Agonist
  • BMS-986321
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo®
  • BMS-936558
Active Comparator: Sunitinib or Cabozantinib
Participants in Arm B will receive the Investigator's choice of either one of two treatment options.
Drug: Sunitinib
Specified dose on specified days
Other Names:
  • Sutent®
Drug: Cabozantinib
Specified dose on specified days
Other Names:
  • Cabometyx®
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 ]

2. Overall survival (OS)
[ Time Frame: 27-48 months ]

Secondary Outcome Measures:
1. Progression-free survival (PFS) by BICR
[ Time Frame: 27-48 months ]

2. Incidence of treatment-related Adverse Events (AEs)
[ Time Frame: Up to 5 years ]

3. ORR using RECIST 1.1 by investigator and in biomarker population
[ Time Frame: 27-48 months ]

4. PFS by investigator and in biomarker population
[ Time Frame: 27-48 months ]

5. OS in biomarker population
[ Time Frame: 27-48 months ]

6. 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
  • At least one International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic factors 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 may be enrolled if certain criteria are met
  • Archival tumor tissue available

Exclusion Criteria:

  • Patients who have an active, known or suspected autoimmune disease
  • Patients who have a known additional malignancy that is progressing or requires active treatment
  • Any tumor invading the 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

Other protocol defined inclusion/exclusion criteria could apply

Open or close this module Contacts/Locations
Central Contact Person: Nektar Recruitment
Telephone: 855-482-8676
Email: StudyInquiry@nektar.com
Study Officials: Alison Hannah
Study Director
Nektar Therapeutics
Locations: United States, California
Investigator Site - Whittier
Whittier, California, United States, 90603
United States, Texas
Investigator Site - Houston
Houston, Texas, United States, 77030
United States, Virginia
Investigator Site - Leesburg
Leesburg, Virginia, United States, 20176
Australia, South Australia
Investigator Site - Kurralta Park
Kurralta Park, South Australia, Australia, 5037
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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