Safety and Immunogenicity of PolyPEPI1018 Vaccine in the Treatment of Metastatic Colorectal Cancer (OBERTO) (OBERTO)
|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: NCT03391232|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: Cancer Immunotherapy||Phase 1|
This is a Phase 1, open-label, single-arm, multicenter study to evaluate the safety, tolerability, and immunogenicity of a single subcutaneous (SC) injection of PolyPEPI1018 as an add-on immunotherapy to the standard-of-care maintenance therapy in approximately 10 subjects with mCRC.
The study is composed of a 3‑week Screening Period, the administration of a single dose vaccine (Day 1, Week 0), and a 12‑week Follow‑up Period. The study will be conducted on an outpatient basis.
Screening should be performed in parallel with the subject's completion of the standard-of-care first-line treatment and initiation of the standard-of-care maintenance treatment.
The single dose of PolyPEPI1018 will be administered after the subject initiates the maintenance regimen, and within 3 weeks after the eligibility CT scan was performed (should be performed at the completion of the first-line treatment).
Subjects will be monitored every 3 weeks for 12 weeks after administration of PolyPEPI1018 (i.e. Weeks 3, 6, 9 and 12).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Dose, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Subcutaneous Injection of PolyPEPI1018 Vaccine as an Add-on Immunotherapy to the Standard-of-Care Maintenance Therapy in Subjects With Metastatic Colorectal Cancer (CRC)|
|Actual Study Start Date :||April 9, 2018|
|Estimated Primary Completion Date :||October 9, 2018|
|Estimated Study Completion Date :||December 21, 2018|
Experimental: PolyPEPI1018 CRC Vaccine
The vaccine contains 6 synthetic peptides mixed with the adjuvant Montanide™. The peptides were selected to induce T cell responses against 12 epitopes from 7 cancer testis antigens (CTAs), which are the most frequently expressed CTAs in colorectal cancer. The 6 peptides were optimized with the PEPI biomarker to induce long lasting CRC specific T cell responses.
Biological: Cancer Immunotherapy
PolyPEPI1018 Colorectal Cancer Vaccine
- Incidence of Treatment Related Adverse Events [ Time Frame: 21 days ]Occurrence of at least 1 ≥Grade 4 local adverse event (AE) or 1 ≥Grade 3 systemic AE and/or signs/symptoms, lab toxicities, and/or clinical events that is probably or definitely related to study treatment
- Prediction of T cell responses [ Time Frame: 21 days ]To determine epitopes of PolyPRPI1018 capable of inducing T cell responses in each study subject
- Measure T cell responses [ Time Frame: 12 weeks ]To measure epitope specific T cell responses in each study subjects
- Correlation between predicted and measured T cell responses [ Time Frame: 12 weeks ]Correlations between PEPIs identified by the PEPI Test and effector and memory T cell responses measured by ELISPOT and PHPC immunogenicity assays
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): NCT03391232
|Contact: Franco Lori, MD, PhD||+39 347 email@example.com|
|Contact: Julianna Lisziewicz, PhDfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Joleen Hubbard, MD 507-405-0312 email@example.com|
|Universiti di Pisa||Not yet recruiting|
|Pisa, PI, Italy|
|Contact: Chiara Cremolini, MD|
|Study Chair:||Lori Franco, MD, PhD||Treos Bio Zrt|