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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03745807

Enrollment

Registered

2018-11-19

Start date

2019-04-09

Completion date

2019-12-18

Last updated

2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

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.

Interventions

BIOLOGICALNKTR-214

Specified dose on specified days

BIOLOGICALNivolumab

Specified dose on specified days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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/

Design outcomes

Primary

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

Measure	Time frame
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
Incidence of anti-drug antibodies (ADA) to NKTR-214	Approximately 2 years
Maximum observed concentration (Cmax)	Approximately 2 years
Best overall response (BOR)	Approximately 2 years
Duration of response (DOR)	Approximately 2 years
Incidence of anti-drug antibodies (ADA) to nivolumab	Approximately 2 years
Time of maximum observed concentration (Tmax)	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026