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

  • Interventional
  • Not Recruiting
  • NCT04208958
Eligibility Details Visit Clinicaltrials.gov

Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

This study will evaluate the safety and efficacy of VE800 in combination with Nivolumab in patients with selected types of advanced or metastatic cancer

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.

Gender
All

Age Group
18 Years and up

Accepting 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

At a Glance

National Government IDNCT04208958

IRB#IRB19-1676

Lead SponsorVedanta Biosciences, Inc.

Lead PhysicianDaniel Catenacci

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting