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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224176

Enrollment

Registered

2018-12-07

Start date

2019-02-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

advanced malignant tumors

Interventions

investigational material(s) Generic name etc : NKTR-214 (BMS-986321) INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
safety Incidence of adverse events (AEs) Incidence of serious adverse events (SAEs) Incidence of AEs leading to discontinuation Incidence of deaths Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria Incidence of laboratory abnormalities	—

Secondary

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

Measure

Time frame

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

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026