ClinicalTrials.gov

History of Changes for Study: NCT03635983
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Latest version (submitted August 31, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 16, 2018 None (earliest Version on record)
2 September 10, 2018 Study Status and Contacts/Locations
3 September 25, 2018 Recruitment Status, Contacts/Locations, Study Status and Oversight
4 October 8, 2018 Contacts/Locations and Study Status
5 October 22, 2018 Contacts/Locations and Study Status
6 November 5, 2018 Contacts/Locations and Study Status
7 November 19, 2018 Contacts/Locations and Study Status
8 December 3, 2018 Contacts/Locations and Study Status
9 December 18, 2018 Contacts/Locations and Study Status
10 April 1, 2019 Contacts/Locations and Study Status
11 May 31, 2019 Contacts/Locations and Study Status
12 June 17, 2019 Contacts/Locations, Study Status and Arms and Interventions
13 July 12, 2019 Contacts/Locations and Study Status
14 July 29, 2019 Contacts/Locations and Study Status
15 August 28, 2019 Contacts/Locations and Study Status
16 September 6, 2019 Contacts/Locations and Study Status
17 September 27, 2019 Contacts/Locations and Study Status
18 October 2, 2019 Contacts/Locations and Study Status
19 October 7, 2019 Contacts/Locations and Study Status
20 October 9, 2019 Contacts/Locations and Study Status
21 October 15, 2019 Contacts/Locations and Study Status
22 October 17, 2019 Contacts/Locations and Study Status
23 October 22, 2019 Contacts/Locations and Study Status
24 November 1, 2019 Contacts/Locations and Study Status
25 November 11, 2019 Contacts/Locations and Study Status
26 November 15, 2019 Contacts/Locations and Study Status
27 November 25, 2019 Contacts/Locations and Study Status
28 November 26, 2019 Contacts/Locations and Study Status
29 December 4, 2019 Contacts/Locations and Study Status
30 December 9, 2019 Contacts/Locations and Study Status
31 December 16, 2019 Contacts/Locations and Study Status
32 January 6, 2020 Contacts/Locations and Study Status
33 January 24, 2020 Contacts/Locations and Study Status
34 February 3, 2020 Contacts/Locations and Study Status
35 February 12, 2020 Contacts/Locations and Study Status
36 February 25, 2020 Contacts/Locations and Study Status
37 March 4, 2020 Study Status and Contacts/Locations
38 June 3, 2020 Contacts/Locations, Outcome Measures, Study Status, Eligibility and Conditions
39 June 17, 2020 Contacts/Locations and Study Status
40 June 26, 2020 Contacts/Locations and Study Status
41 July 13, 2020 Contacts/Locations and Study Status
42 July 30, 2020 Contacts/Locations and Study Status
43 August 5, 2020 Study Status and Contacts/Locations
44 August 6, 2020 Study Status
45 August 17, 2020 Contacts/Locations and Study Status
46 August 24, 2020 Contacts/Locations and Study Status
47 September 9, 2020 Contacts/Locations and Study Status
48 September 21, 2020 Contacts/Locations and Study Status
49 October 6, 2020 Contacts/Locations and Study Status
50 October 12, 2020 Contacts/Locations and Study Status
51 October 14, 2020 Contacts/Locations and Study Status
52 October 19, 2020 Contacts/Locations and Study Status
53 October 21, 2020 Contacts/Locations and Study Status
54 October 29, 2020 Contacts/Locations and Study Status
55 November 3, 2020 Study Status and Contacts/Locations
56 November 5, 2020 Contacts/Locations and Study Status
57 November 16, 2020 Contacts/Locations and Study Status
58 December 8, 2021 Recruitment Status, Contacts/Locations, Study Status, Study Design and References
59 January 4, 2022 Study Status
60 January 19, 2022 Contacts/Locations and Study Status
61 June 17, 2022 Contacts/Locations, Study Status, References, Eligibility and Study Design
62 July 18, 2022 Contacts/Locations and Study Status
63 August 1, 2022 Contacts/Locations and Study Status
64 August 31, 2022 Contacts/Locations and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03635983
Submitted Date:  August 16, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: CA045-001
Brief Title: A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Official Title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Secondary IDs: 2018-001423-40 [EudraCT Number]
17-214-08 [Nektar Therapeutics]
Open or close this module Study Status
Record Verification: August 2018
Overall Status: Not yet recruiting
Study Start: September 15, 2018
Primary Completion: August 15, 2023 [Anticipated]
Study Completion: March 15, 2025 [Anticipated]
First Submitted: August 16, 2018
First Submitted that
Met QC Criteria:
August 16, 2018
First Posted: August 17, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
August 16, 2018
Last Update Posted: August 17, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators: Nektar Therapeutics
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 purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread
Detailed Description:
Open or close this module Conditions
Conditions: Melanoma
Keywords: NKTR-214
Nivolumab
Immunotherapy
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: 764 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Combination
NKTR-214 + Nivolumab
Biological: NKTR-214
Specified dose on specified days
Other Names:
  • BMS-986321
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Monotherapy
Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall response rate (ORR) by Blinded Independent Central Review (BICR)
[ Time Frame: Approximately 16 months ]

2. Progression-free survival (PFS) by BICR
[ Time Frame: Approximately 22 months ]

3. Overall survival (OS)
[ Time Frame: Up to 59 months ]

Secondary Outcome Measures:
1. Clinical benefit rate (CBR)
[ Time Frame: Approximately 16 months ]

2. Duration of response (DoR)
[ Time Frame: Approximately 16 months ]

3. Duration of overall complete response (DoCR)
[ Time Frame: Approximately 16 months ]

4. Time to response (TTR)
[ Time Frame: Approximately 16 months ]

5. ORR by investigator and in biomarker population
[ Time Frame: Approximately 16 months ]

6. PFS by investigator and in biomarker population
[ Time Frame: Approximately 22 months ]

7. OS in biomarker population
[ Time Frame: Up to 59 months ]

8. Incidence of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation
[ Time Frame: Up to 5 years ]

9. Incidence of treatment-related AEs
[ Time Frame: Up to 5 years ]

10. Incidence of treatment-related SAEs
[ Time Frame: Up to 5 years ]

11. Incidence of laboratory abnormalities
[ Time Frame: Up to 5 years ]

Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant treatment

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Uveal melanoma
  • Participants with an active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Open or close this module Contacts/Locations
Central Contact Person: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Telephone: please email
Email: Clinical.Trials@bms.com
Central Contact Backup: First line of the email MUST contain NCT # and Site #.
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations: United States, California
Local Institution
La Jolla, California, United States, 92093-0698
Contact:Contact: Site 0014
Local Institution
Los Angeles, California, United States, 90095
Contact:Contact: Site 0061
Local Institution
Palo Alto, California, United States, 94304
Contact:Contact: Site 0122
United States, Colorado
Local Institution
Aurora, Colorado, United States, 80045
Contact:Contact: Site 0051
United States, Connecticut
Local Institution
New Haven, Connecticut, United States, 06510
Contact:Contact: Site 0065
United States, Florida
Local Institution
Miami Beach, Florida, United States, 33140
Contact:Contact: Site 0017
Local Institution
Tampa, Florida, United States, 33612-9497
Contact:Contact: Site 0112
United States, Georgia
Local Institution
Atlanta, Georgia, United States, 30322-1013
Contact:Contact: Site 0012
United States, Kentucky
Local Institution
Louisville, Kentucky, United States, 40202
Contact:Contact: Site 0019
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02215
Contact:Contact: Site 0018
United States, Minnesota
Local Institution
Minneapolis, Minnesota, United States, 55407-3799
Contact:Contact: Site 0050
United States, Missouri
Local Institution
Saint Louis, Missouri, United States, 63110
Contact:Contact: Site 0135
United States, New Jersey
Local Institution
Hackensack, New Jersey, United States, 07061
Contact:Contact: Site 0016
United States, New York
Local Institution
Buffalo, New York, United States, 14263
Contact:Contact: Site 0087
United States, Ohio
Local Institution
Cleveland, Ohio, United States, 44106
Contact:Contact: Site 0037
Local Institution
Cleveland, Ohio, United States, 44106
Contact:Contact: Site 0049
United States, Oregon
Local Institution
Portland, Oregon, United States, 97213
Contact:Contact: Site 0011
Local Institution
Portland, Oregon, United States, 97239
Contact:Contact: Site 0013
United States, Pennsylvania
Local Institution
Bethlehem, Pennsylvania, United States, 18015
Contact:Contact: Site 0052
Local Institution
Philadelphia, Pennsylvania, United States, 19111
Contact:Contact: Site 0015
United States, Texas
Local Institution
Houston, Texas, United States, 77030-4009
Contact:Contact: Site 0001
United States, Virginia
Local Institution
Fairfax, Virginia, United States, 22031
Contact:Contact: Site 0064
Argentina
Local Institution
Caba, Argentina, 1199
Contact:Contact: Site 0106
Local Institution
Caba, Argentina, 1426
Contact:Contact: Site 0108
Argentina, Buenos Aires
Local Institution
Autonoma, Buenos Aires, Argentina, C118AAT
Contact:Contact: Site 0107
Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430
Contact:Contact: Site 0109
Australia, New South Wales
Local Institution
North Sydney, New South Wales, Australia, 2060
Contact:Contact: Site 0053
Australia, Queensland
Local Institution
Cairns, Queensland, Australia, 4870
Contact:Contact: Site 0058
Australia, Victoria
Local Institution
Melbourne, Victoria, Australia, 3000
Contact:Contact: Site 0054
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Contact:Contact: Site 0097
Brazil, Minas Gerais
Local Institution
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Contact:Contact: Site 0125
Brazil, RIO Grande DO SUL
Local Institution
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact:Contact: Site 0124
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Contact:Contact: Site 0127
Brazil, SAO Paulo
Local Institution
Barretos, SAO Paulo, Brazil, 14784-400
Contact:Contact: Site 0126
Canada
Local Institution
Quebec, Canada, G1R 2J6
Contact:Contact: Site 0069
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Contact:Contact: Site 0121
Canada, British Columbia
Local Institution
Abbotsford, British Columbia, Canada, V2S 0C2
Contact:Contact: Site 0068
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8V 5C2
Contact:Contact: Site 0066
Local Institution
Kitchener, Ontario, Canada, N2G 1G3
Contact:Contact: Site 0067
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Contact:Contact: Site 0041
Italy
Local Institution
Bari, Italy, 70124
Contact:Contact: Site 0044
Local Institution
Genova, Italy, 16132
Contact:Contact: Site 0046
Local Institution
Medola, Italy, 47014
Contact:Contact: Site 0113
Local Institution
Milan, Italy, 20141
Contact:Contact: Site 0045
Local Institution
Napoli, Italy, 80131
Contact:Contact: Site 0043
Local Institution
Padova, Italy, 35128
Contact:Contact: Site 0047
Local Institution
Siena, Italy, 53100
Contact:Contact: Site 0042
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: BMS Clinical Trial Information
Description: BMS Clinical Trial Patient Recruiting
Description: FDA Safety Alerts and Recalls
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services