Description:
This study will evaluate the safety and efficacy of VE800 in combination with Nivolumab in
patients with selected types of advanced or metastatic cancer
Title
- Brief Title: Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
- Official Title: Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Clinical Trial IDs
- ORG STUDY ID:
VE800-001
- NCT ID:
NCT04208958
Conditions
- Metastatic Cancer
- Melanoma
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Colorectal Cancer
Interventions
Drug | Synonyms | Arms |
---|
VE800 | | VE800 combination treatment with Nivolumab |
Nivolumab | Opdivo | VE800 combination treatment with Nivolumab |
Vancomycin Oral Capsule | Vancoccin | VE800 combination treatment with Nivolumab |
Purpose
This study will evaluate the safety and efficacy of VE800 in combination with Nivolumab in
patients with selected types of advanced or metastatic cancer
Detailed Description
CONSORTIUM-IO is a first-in-human multicenter, open-label study, where it's main objectives
will evaluate:
- Safety and tolerability of VE800 in combination with Nivolumab
- Efficacy as measured by a total of overall response rate.
The study will enroll approximately 111 patients with melanoma, patients with
gastric/gastroesophageal junction (GEJ) adenocarcinoma, and patients with
microsatellite-stable (MSS) colorectal cancer (CRC).
Nivolumab is an already approved by the FDA (the U.S. Food and Drug Administration), however,
it is not approved for the study cancer indications. VE800 is the investigational product and
alive VE800 bacterial consortium were designed to elicit an immune response.
Trial Arms
Name | Type | Description | Interventions |
---|
VE800 combination treatment with Nivolumab | Experimental | Subjects will receive 5 days of oral vancomycin, followed by daily VE800 in combination with Nivolumab every 4 weeks. | - VE800
- Nivolumab
- Vancomycin Oral Capsule
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety and tolerability of VE800 in combination with nivolumab: incidence of adverse events |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Will be measured in terms of incidence of adverse events |
Secondary Outcome Measures
Measure: | Duration of response (DOR) |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Evaluation of clinical benefit |
Measure: | Best Overall Response |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Evaluation of clinical benefit |
Measure: | Disease Control Rate (DCR) |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Evaluation of clinical benefit |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Evaluation of clinical benefit |
Measure: | Overall Survival (OS) |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Evaluation of clinical benefit |
Measure: | Detection of VE800 bacterial strain colonization in stool |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Measured by pharmacokinetics (PK) of VE800 |
Measure: | Degree of VE800 bacterial strain colonization in stool |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Measured by pharmacokinetics (PK) of VE800colonization in stool |
Measure: | Duration of VE800 bacterial strain colonization in stool |
Time Frame: | From the first dose to 100 days after the last dose |
Safety Issue: | |
Description: | Measured by pharmacokinetics (PK) of VE800colonization in stool |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Vedanta Biosciences, Inc. |
Trial Keywords
- Metastatic Cancer
- VE800
- Nivolumab
- Opdivo
- Melanoma
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- GEJ Adenocarcinoma
- Colorectal Cancer
- CRC-MSS
- Vedanta
- BMS
Last Updated
June 23, 2021