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
| Verified date | September 2021 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Local Institution | Chuo-ku | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Nektar Therapeutics, Ono Pharmaceutical Co. Ltd |
Japan,
| 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 |
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