Esophageal Cancer Clinical Trial

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

Summary

This study will evaluate the safety and efficacy of VE800 in combination with immunotherapy-drugs-are-boosting-survival/" >Nivolumab in patients with selected types of advanced or metastatic cancer

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Full Description

CONSORTIUM-IO was the first-in-human multicenter, open-label study; the main objectives were to evaluate:

Safety and tolerability of VE800 in combination with nivolumab
Efficacy as measured by objective response rate

The study planned to enroll approximately 111 patients with melanoma, gastric/gastroesophageal junction (GEJ) adenocarcinoma, or microsatellite-stable (MSS) colorectal cancer (CRC).

Nivolumab is already approved by the U.S. Food and Drug Administration (FDA), however, it is not approved for the study cancer indications. VE800 was the investigational product, which was designed to enhance the immune response to the tumor.

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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

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

56

Study ID:

NCT04208958

Recruitment Status:

Completed

Sponsor:

Vedanta Biosciences, Inc.

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There are 17 Locations for this study

See Locations Near You

HonorHealth Research Institute
Scottsdale Arizona, 85258, United States
University of California Los Angeles
Los Angeles California, 90095, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
The Angeles Clinic and Research Institute - West Los Angeles Office
Santa Monica California, 90404, United States
University of California Los Angeles
Santa Monica California, 90404, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
The University of Chicago
Chicago Illinois, 60637, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Washington University School of Medicine Siteman Cancer Center
Saint Louis Missouri, 63110, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States
New York University Medical Oncology Associates
New York New York, 10016, United States
Weill Cornell Medicine
New York New York, 10065, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
The Miriam Hospital
Providence Rhode Island, 02906, United States
Baylor Scott and White Center for Advanced Heart and Lung Disese
Dallas Texas, 75246, United States
Huntsman Cancer Institute and Hospital
Salt Lake City Utah, 84112, United States
Swedish Medical Oncology - First Hill
Seattle Washington, 98104, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

56

Study ID:

NCT04208958

Recruitment Status:

Completed

Sponsor:


Vedanta Biosciences, Inc.

How clear is this clinincal trial information?

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