An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- advanced malignant tumors
- Registration Number
- JPRN-jRCT2080224176
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Incidence of adverse events (AEs)<br>Incidence of serious adverse events (SAEs)<br>Incidence of AEs leading to discontinuation<br>Incidence of deaths<br>Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria<br>Incidence of laboratory abnormalities
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>Maximum observed concentration (Cmax)<br>Time of maximum observed concentration (Tmax)<br>Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]<br>Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] <br>Total body clearance (CLT)<br>Volume of distribution (Vz)<br>Apparent terminal phase half-life (T-HALF)<br>Trough observed concentration at the end of the dosing interval (Ctrough)<br>Incidence of anti-drug antibodies (ADA) to NKTR-214<br>Incidence of anti-drug antibodies (ADA) to nivolumab<br>Best overall response (BOR)<br>Duration of response (DOR)