A Global Multicenter Phase 1/2 Trial of EO2463, a Novel Microbial-Derived Peptide Therapeutic Vaccine, as Monotherapy, and in Combination With Lenalidomide and Rituximab, for Treatment of Patients With Indolent Non-Hodgkin's Lymphoma
Summary
The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent NHL
Detailed description
EO2463 Is an innovative cancer peptide therapeutic vaccine based on the homologies between tumor associated antigens and microbiome-derived peptides that will be administered alone and in combination with lenalidomide, rituximab, and lenalidomide/rituximab to generate safety and preliminary efficacy data in patients with indolent NHL
Arms & interventions
- BiologicalEO2463
Multiple dose of EO2463
- Druglenalidomide
D1-21 of 4-weekly cycles
- Biologicalrituximab
Multiple doses of rituximab
Outcome measures
Primary
Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment |
Incidences of adverse events, Treatment-Emergent Adverse events, Serious Adverse Events, Deaths, and Laboratory Abnormalities Using the National Cancer Institute-Common Terminology Criteria for Adverse events (NCI-CTCAE) V5.0.
Time frame: Up to 24 months
Phase 2: Overall Response Rate
Overall Response Rate According to the Lugano Classification 2014 during EO2463 Monotherapy
Time frame: Up to 24 months
Phase 2: Complete Response Rate
Complete remission (CR)-rate according to the Lugano Classification 2014 during therapy with the combination of EO2463/lenalidomide/rituximab.
Time frame: Up to 24 months
Secondary
Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463
Time frame: Up to 24 months
Evaluation of Overall Survival
Time frame: Up to 7 years after last patient enrolled
Eligibility criteria
Study locations (4)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
Rochester, New York, 14642
University of Washington-Seattle Cancer Care Alliance
Seattle, Washington, 98109