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Clinical Trial 20478
Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04208958
Phase: Phase I
Prinicipal Investigator: Zeynep Eroglu
Study Title
Phase 1 Study of VE800 and Nivolumab in Patients with Selected Types of Advanced or Metastatic Cancer
Summary
This study will evaluate the safety and efficacy of VE800 in combination with Nivolumab in patients with selected types of advanced or metastatic cancer
Objective
Primary objectives: To evaluate the safety and tolerability of VE800 in combination with nivolumab using Common Terminology Criteria for Adverse Events (CTCAE, v. 5.0) To evaluate clinical activity as measured by objective response rate (ORR) of the study drug combination using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Secondary objectives: To evaluate additional measures of clinical benefit, including: - Duration of response (DOR) according to RECIST 1.1 - Progression-free survival (PFS) according to RECIST 1.1 - PFS rate at 2 months and every 2 months thereafter until 1 year, and then every 12 weeks after 1 year - Overall survival (OS) - To evaluate the pharmacokinetics (PK) of VE800 - Detection of each VE800 strain in stool - Degree and duration of VE800 strain colonization
Therapies
Medications
BMS-936558 (Nivolumab); Nivolumab (Opdivo); VE800 (); Vancomycin ()
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