An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid Tumors

A Phase 1 Study to Evaluate Safety and Tolerability of NKTR-214 (BMS-986321) Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors

The purpose of this study is to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Biological: Nivolumab; Biological: NKTR-214

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1040045
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Inclusion Criteria:

• Histologic or cytological confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor with measurable disease per RECIST v1.1.
• Life expectancy >12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

• Active, known or suspected autoimmune disease.
• History of organ transplant that requires use of immune suppressive agents.
• Prior surgery or radiotherapy within 14 days of Cycle 1 Day 1. Participants must have recovered from all radiation-related, toxicities and not requiring corticosteroids.

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination; NKTR-214 + nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Biological: NKTR-214; Specified dose on specified days; Other Names: BMS-986321; Bempegaldesleukin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	Approximately 2 years
Incidence of serious adverse events (SAEs)	Approximately 2 years
Incidence of AEs leading to discontinuation	Approximately 2 years
Incidence of deaths	Approximately 2 years
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria	Approximately 2 years
Incidence of laboratory abnormalities	Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of response (DOR)	Approximately 2 years
Time of maximum observed concentration (Tmax)	Approximately 2 years
Trough observed serum concentration at the end of the dosing interval (Ctrough)	Approximately 2 years
Maximum observed concentration (Cmax)	Approximately 2 years
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]	Approximately 2 years
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Approximately 2 years
Total body clearance (CLT)	Approximately 2 years
Volume of distribution (Vz)	Approximately 2 years
Apparent terminal phase half-life (T-HALF)	Approximately 2 years
Incidence of anti-drug antibodies (ADA) to NKTR-214	Approximately 2 years
Incidence of anti-drug antibodies (ADA) to nivolumab	Approximately 2 years
Best overall response (BOR)	Approximately 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co. Ltd; Nektar Therapeutics

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA045-010; 18-214-14 (Other Identifier: Nektar Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes