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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Advanced Cancer

Treatments

Biological: Nivolumab

Biological: NKTR-214

Study type

Interventional

Funder types

Industry

Identifiers

NCT03745807

18-214-14 (Other Identifier)

CA045-010

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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/exclusion criteria could apply