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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Cancer

Intervention / Treatment
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* Biological: NKTR-214
* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination<br>NKTR-214 + nivolumab | Biological: NKTR-214<br>* Specified dose on specified days<br>* Other names: BMS-986321;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Volume of distribution (Vz) |  | Approximately 2 years | 
| 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 | 
| Incidence of anti-drug antibodies (ADA) to nivolumab |  | Approximately 2 years | 
| Best overall response (BOR) |  | Approximately 2 years | 
| Duration of response (DOR) |  | Approximately 2 years |