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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745807
• Other study ID #: CA045-010
• Secondary ID: 18-214-14
• Status: Completed
• Phase: Phase 1
• Start date: April 9, 2019
• Est. completion date: December 18, 2019

Study information

• Verified date: September 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Biological:
• NKTR-214
Specified dose on specified days
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
Japan	Local Institution	Chuo-ku	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Nektar Therapeutics, Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Approximately 2 years
Primary	Incidence of serious adverse events (SAEs)		Approximately 2 years
Primary	Incidence of AEs leading to discontinuation		Approximately 2 years
Primary	Incidence of deaths		Approximately 2 years
Primary	Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria		Approximately 2 years
Primary	Incidence of laboratory abnormalities		Approximately 2 years
Secondary	Maximum observed concentration (Cmax)		Approximately 2 years
Secondary	Time of maximum observed concentration (Tmax)		Approximately 2 years
Secondary	Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]		Approximately 2 years
Secondary	Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]		Approximately 2 years
Secondary	Total body clearance (CLT)		Approximately 2 years
Secondary	Volume of distribution (Vz)		Approximately 2 years
Secondary	Apparent terminal phase half-life (T-HALF)		Approximately 2 years
Secondary	Trough observed serum concentration at the end of the dosing interval (Ctrough)		Approximately 2 years
Secondary	Incidence of anti-drug antibodies (ADA) to NKTR-214		Approximately 2 years
Secondary	Incidence of anti-drug antibodies (ADA) to nivolumab		Approximately 2 years
Secondary	Best overall response (BOR)		Approximately 2 years
Secondary	Duration of response (DOR)		Approximately 2 years

External Links

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