Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vedanta Biosciences, Inc.
• Collaborators: Bristol-Myers Squibb; Bristol-Myers Squibb (BMS)
• Treatments: Nivolumab; Vancomycin

Criteria

Partial 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)

Partial 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