Phase 2
Completed N=56
Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Source: ClinicalTrials.gov NCT04208958 ↗Enrolled (actual)
56
Serious AEs
28.6%
Results posted
Aug 2023
Primary outcomePrimary: Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events — 16; 19; 12; 47 participants
Summary
This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events |
16; 19; 12; 47; 9; 9 | — |
| PRIMARY Objective Response Rate (ORR) |
1; 0; 0 | — |
| SECONDARY Duration of Response (DOR) |
5.6 | — |
| SECONDARY Best Overall Response |
0; 0; 1; 0; 3; 10 | — |
| SECONDARY Disease Control Rate (DCR) |
3; 9; 3 | — |
| SECONDARY Progression-Free Survival (PFS) |
1.8; 1.9; 1.8; 1.8 | — |
| SECONDARY Overall Survival (OS) |
5.8; NA; 7.6 | — |
| SECONDARY Detection of VE800 Bacterial Strain Colonization in Stool |
— | — |
| SECONDARY Degree of VE800 Bacterial Strain Colonization in Stool |
— | — |
| SECONDARY Duration of VE800 Bacterial Strain Colonization in Stool |
— | — |
Eligibility Criteria
Partial Inclusion Criteria:
- Patients with advanced or metastatic cancer who had 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 have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual was allowed)
Partial Exclusion Criteria:
- Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion did not apply to patients with melanoma)
- Receipt of any conventional or investigational systemic anti-cancer therapy within 21 days prior to the first dose of vancomycin
- Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab were 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 disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment were permitted to enroll.
- Patients with known active hepatitis (e.g., hepatitis B or C) NOTE: Patients with previously treated hepatitis B or C were permitted to enroll if there was 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
Data sourced from ClinicalTrials.gov (NCT04208958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.