Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02721043|
Recruitment Status : Recruiting
First Posted : March 28, 2016
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Biological: Peptides Drug: Poly-ICLC Drug: Lenalidomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, Open Label, Study Of Pgv001 A Multi-Peptide Therapeutic Vaccine Platform For Use In The Treatment Of Malignancies In The Adjuvant Setting|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Personalized Genome Vaccine 001
PGV-001 (peptides + Poly-ICLC)
Peptides: 100mcg per peptide per dose.
Poly-ICLC (Hiltonol®, Oncovir): 1.4mg (0.7mL, 2mg/mL)
Each subject will receive ten (10) total doses of PGV001. PGV001 will be administered on study visit: v4, v6, v8, v10, v12, v14, v16, v18, v20 and v22.
Each subject will receive ten additional (10) total doses of the Poly-ICLC. The additional Poly-ICLC dose will be administered on study visit: v5, v7, v9, v11, v13, v15, v17, v19, v21 and v23.
Other Name: Hiltonol®
10mg once daily oral dose for maintenance therapy in multiple myeloma patients.
- Dose-limiting toxicities (DLT) [ Time Frame: up to day 42 ]toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale
- Toxicity grading using CTCAE scale [ Time Frame: one year ]safety will be measured by number of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale
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): NCT02721043
|Contact: Nina Bhardwaj, MD, PhD||212-824-8427||Nina.Bhardwaj@mssm.edu|
|Contact: Philip Friedlander, MD, PhD||212-824-8588||Philip.Friedlander@mssm.edu|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Erlinda Sacris, RN, OCN, CCRC, CCRP 212-824-9359 firstname.lastname@example.org|
|Principal Investigator: Nina Bhardwaj, MD, PhD|
|Principal Investigator:||Nina Bhardwaj, MD, PhD||Icahn School of Medicine at Mount Sinai|