Clinical trial NCT04208958: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: Vedanta Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2019-12-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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)
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
timeFrame: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up
measure: Objective Response Rate (ORR)
timeFrame: 18 months (first patient enrolled to last patient visit completed)
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to two years
measure: Best Overall Response
timeFrame: Up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: Progression-Free Survival (PFS)
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: 18 months (first patient enrolled to last patient visit completed)
measure: Detection of VE800 Bacterial Strain Colonization in Stool
timeFrame: 18 months (first patient enrolled to last patient visit completed)
measure: Degree of VE800 Bacterial Strain Colonization in Stool
timeFrame: 18 months (first patient enrolled to last patient visit completed)
measure: Duration of VE800 Bacterial Strain Colonization in Stool
timeFrame: 18 months (first patient enrolled to last patient visit completed)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Santa Monica
country: United States
facility: The Angeles Clinic and Research Institute - West Los Angeles Office
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles
state: California
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Saint Louis
country: United States
facility: Washington University School of Medicine Siteman Cancer Center
state: Missouri
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: New York
country: United States
facility: New York University Medical Oncology Associates
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Dallas
country: United States
facility: Baylor Scott and White Center for Advanced Heart and Lung Disese
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute and Hospital
state: Utah
city: Seattle
country: United States
facility: Swedish Medical Oncology - First Hill
state: Washington
Study officials:
affiliation: SCRI - Florida Cancer Specialists - Sarasota Cattlemen Office (Coordinating Investigator)
name: Judy Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: