Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer (Consortium-IO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04208958|
Recruitment Status : Active, not recruiting
First Posted : December 23, 2019
Last Update Posted : June 23, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Melanoma Gastric Cancer Gastroesophageal Junction Adenocarcinoma Colorectal Cancer||Biological: VE800 Drug: Nivolumab Drug: Vancomycin Oral Capsule||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
This study design will help determine how safe and effective the study drug, VE800, in combination with nivolumab in patients with advanced/metastatic cancer.
The following cohorts of patients with advanced/metastatic cancer will be enrolled:
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer|
|Actual Study Start Date :||January 23, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: VE800 combination treatment with Nivolumab
Subjects will receive 5 days of oral vancomycin, followed by daily VE800 in combination with Nivolumab every 4 weeks.
VE800 is an orally administered (PO) live biotherapeutic product (LBP) consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Other Name: Opdivo
Drug: Vancomycin Oral Capsule
Vancomycin is an antibiotic used to treat or prevent infection.
Other Name: Vancoccin
- 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 ]Will be measured in terms of incidence of adverse events
- Evaluate clinical activity [ Time Frame: From the first dose to 100 days after the last dose ]Will be measured as objective response rate (ORR)
- Duration of response (DOR) [ Time Frame: From the first dose to 100 days after the last dose ]Evaluation of clinical benefit
- Best Overall Response [ Time Frame: From the first dose to 100 days after the last dose ]Evaluation of clinical benefit
- Disease Control Rate (DCR) [ Time Frame: From the first dose to 100 days after the last dose ]Evaluation of clinical benefit
- Progression-Free Survival (PFS) [ Time Frame: From the first dose to 100 days after the last dose ]Evaluation of clinical benefit
- Overall Survival (OS) [ Time Frame: From the first dose to 100 days after the last dose ]Evaluation of clinical benefit
- Detection of VE800 bacterial strain colonization in stool [ Time Frame: From the first dose to 100 days after the last dose ]Measured by pharmacokinetics (PK) of VE800
- Degree of VE800 bacterial strain colonization in stool [ Time Frame: From the first dose to 100 days after the last dose ]Measured by pharmacokinetics (PK) of VE800colonization in stool
- Duration of VE800 bacterial strain colonization in stool [ Time Frame: From the first dose to 100 days after the last dose ]Measured by pharmacokinetics (PK) of VE800colonization in stool
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208958
|Responsible Party:||Vedanta Biosciences, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 23, 2019 Key Record Dates|
|Last Update Posted:||June 23, 2021|
|Last Verified:||June 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Gastroesophageal Junction Adenocarcinoma
Neoplasms, Second Primary
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Glandular and Epithelial
Head and Neck Neoplasms