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

NCT04208958 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: VE800-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 18

Brief Summary

This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer

Conditions

Metastatic Cancer; Melanoma; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Colorectal Cancer

Keywords

Metastatic Cancer; VE800; Nivolumab; Opdivo; Melanoma; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; GEJ Adenocarcinoma; Colorectal Cancer; CRC-MSS; Vedanta; BMS

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events

  Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events

  From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  18 months (first patient enrolled to last patient visit completed)

Secondary Outcomes (8)

• Duration of Response (DOR)

  Up to two years

• Best Overall Response

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Progression-Free Survival (PFS)

  From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up and then follow-up for survival every 90 days.

• Overall Survival (OS)

  18 months (first patient enrolled to last patient visit completed)

Study Arms (1)

VE800 combination treatment with nivolumab

EXPERIMENTAL

Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.

Biological: VE800; Drug: Nivolumab; Drug: Vancomycin Oral Capsule

Interventions

VE800 BIOLOGICAL

VE800 is an orally administered (PO) live biotherapeutic product (LBP) consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under Good Manufacturing Practice (GMP) conditions. These strains were selected for their ability to induce an immune response.

VE800 combination treatment with nivolumab

Nivolumab DRUG

Nivolumab is an approved medication that blocks antibodies for certain types of cancer.

Also known as: Opdivo

VE800 combination treatment with nivolumab

Vancomycin Oral Capsule DRUG

Vancomycin is an antibiotic used to treat or prevent infection.

Also known as: Vancocin

VE800 combination treatment with nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vedanta Biosciences, Inc.: lead
• Bristol-Myers Squibb: collaborator

Study Sites (18)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Pacific Hematology Oncology Associates

San Francisco, California, 94115, United States

Location

The Angeles Clinic and Research Institute - West Los Angeles Office

Santa Monica, California, 90404, United States

Location

University of California Los Angeles

Santa Monica, California, 90404, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

New York University Medical Oncology Associates

New York, New York, 10016, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Baylor Scott and White Center for Advanced Heart and Lung Disese

Dallas, Texas, 75246, United States

Location

Huntsman Cancer Institute and Hospital

Salt Lake City, Utah, 84112, United States

Location

Swedish Medical Oncology - First Hill

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Melanoma; Stomach Neoplasms; Colorectal Neoplasms

Interventions

Nivolumab; Vancomycin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides

Results Point of Contact

• Title: Jeffrey Silber
• Organization: Vedanta Biosciences

ConsortiumIO-ctinquiries@vedantabio.com

(857) 706-1427

Study Officials

• Judy Wang, MD

  SCRI - Florida Cancer Specialists - Sarasota Cattlemen Office (Coordinating Investigator)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was designed to help determine the safety and effectiveness of the study drug, VE800, in combination with nivolumab in patients with advanced/metastatic cancer. The following cohorts of patients with advanced/metastatic cancer were enrolled: * Melanoma * Gastric/gastroesophageal junction (GEJ) adenocarcinoma * Colorectal cancer (microsatellite-stable) (CRC-MSS)

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 23, 2019
• Study Start: January 23, 2020
• Primary Completion: August 26, 2021
• Study Completion: February 23, 2023
• Last Updated: October 27, 2025
• Results First Posted: August 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)