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

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Biological: NKTR-214; Biological: Nivolumab

• Registration Number: NCT03745807
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Study Start: 2019-04-09
• Primary Completion: 2019-12-18
• Study Completion: 2019-12-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination	NKTR-214	NKTR-214 + nivolumab
Combination	Nivolumab	NKTR-214 + nivolumab

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Chuo-ku, Tokyo, Japan