Clinical trial NCT03745807: An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Nektar Therapeutics
name: Ono Pharmaceutical Co. Ltd
First posted: 2018-11-19
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Approximately 2 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Approximately 2 years
measure: Incidence of AEs leading to discontinuation
timeFrame: Approximately 2 years
measure: Incidence of deaths
timeFrame: Approximately 2 years
measure: Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
timeFrame: Approximately 2 years
measure: Incidence of laboratory abnormalities
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Approximately 2 years
measure: Time of maximum observed concentration (Tmax)
timeFrame: Approximately 2 years
measure: Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Approximately 2 years
measure: Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Approximately 2 years
measure: Total body clearance (CLT)
timeFrame: Approximately 2 years
measure: Volume of distribution (Vz)
timeFrame: Approximately 2 years
measure: Apparent terminal phase half-life (T-HALF)
timeFrame: Approximately 2 years
measure: Trough observed serum concentration at the end of the dosing interval (Ctrough)
timeFrame: Approximately 2 years
measure: Incidence of anti-drug antibodies (ADA) to NKTR-214
timeFrame: Approximately 2 years
measure: Incidence of anti-drug antibodies (ADA) to nivolumab
timeFrame: Approximately 2 years
measure: Best overall response (BOR)
timeFrame: Approximately 2 years
measure: Duration of response (DOR)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: