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

NCT03745807 | Completed Phase 1 FDA Drug

• 2 other identifiers: CA045-01018-214-14
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• Maximum observed concentration (Cmax)

  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

Study Arms (1)

Combination

EXPERIMENTAL

NKTR-214 + nivolumab

Biological: NKTR-214; Biological: Nivolumab

Interventions

NKTR-214 BIOLOGICAL

Specified dose on specified days

Also known as: Bempegaldesleukin, BMS-986321

Combination

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Combination

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Nektar Therapeutics: collaborator
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (1)

Local Institution

Chuo-ku, Tokyo, 1040045, Japan

Location

Related Links

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

MeSH Terms

Interventions

bempegaldesleukin; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 19, 2018
• Study Start: April 9, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)