Safety Study of BMS-986016 With or Without Nivolumab in Subjects With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Advanced Solid Tumors
- Registration Number
- JPRN-jRCT2080223428
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
Exclusion Criteria
Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
Other concomitant malignancies (with some exceptions per protocol)
Any active autoimmune disease or history of known or suspected autoimmune disease
History of uncontrolled or significant cardiovascular disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>The safety and tolerability of BMS-986016 administered alone and in<br>combination with nivolumab<br>Rate of AEs, serious adverse events (SAEs), deaths, and laboratory abnormalities
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>other<br>The pharmacokinetics (PK) of BMS-986016 administered alone and in combination with nivolumab<br>The preliminary anti-tumor activity of BMS-986016 administered alone and in combination with nivolumab<br>The immunogenicity of BMS-986016 administered alone and in combination with nivolumab<br>PK parameters of BMS-986016 such as Cmax, Tmax, Ctrough, Ctau, Css,avg,<br>AUC(TAU), CLT, Vss, T-HALFeff AUC, T-HALFeff Cmax, AI_AUC, AI_Cmax, AI_Ctau, DF<br>Best overall response (BOR) and duration of response (DOR)<br>Frequency of subjects who develop specific ADA to BMS-986016