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Clinical Trial 20478

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04208958

Phase: Phase I
Prinicipal Investigator: Zeynep Eroglu

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Study Title

Phase 1 Study of VE800 and Nivolumab in Patients with Selected Types of Advanced or Metastatic Cancer


This study will evaluate the safety and efficacy of VE800 in combination with Nivolumab in patients with selected types of advanced or metastatic cancer


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




BMS-936558 (Nivolumab); Nivolumab (Opdivo); VE800 (); Vancomycin ()

Inclusion Criteria

  • Patients with advanced or metastatic cancer who have received no more than 3 lines of prior systemic therapy for advanced/metastatic disease.
  • Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1
  • Tumor lesions amenable for biopsy, if deemed safe by the investigator
  • Toxicity from prior cancer therapy should resolve to CTCAE Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual is allowed)
  • Other criteria apply

  • Exclusion Criteria

  • Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion does not apply to patients with melanoma)
  • Receipt of any conventional or investigational systemic anti-cancer therapy within 26 days prior to the start of study treatment
  • Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab are acceptable as prophylaxis for bone metastasis.
  • Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment
  • Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin not requiring systemic treatment are permitted to enroll.
  • Patients with known active hepatitis (e.g., hepatitis B or C) NOTE: Patients with previously treated hepatitis B or C are permitted to enroll if there is evidence of documented resolution of infection.
  • Received a fecal transplant, spore or other preparation of fecal material, isolated bacterial products, genetically modified bacteria, or VE800
  • Other criteria apply

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