PolyPEPI1018 Vaccine and CDx for 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03391232|
Recruitment Status : Active, not recruiting
First Posted : January 5, 2018
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: PolyPEPI1018 CRC Vaccine||Phase 1 Phase 2|
This is a Phase I/II, open-label, single-arm, multicenter study to evaluate the safety, tolerability, immunogenicity and efficacy of a multiple subcutaneous injection of PolyPEPI1018 as an add-on immunotherapy to the standard-of-care maintenance therapy in approximately 15 subjects with metastatic colorectal cancer.
The first part of the study investigates the administration of a single vaccine dose during 12‑week follow‑up period on an outpatient basis. Screening is 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. A single dose of PolyPEPI1018 is administered after the subject initiates the maintenance regimen, and within 3 weeks after the eligibility CT scan was performed. Subjects are monitored every 3 weeks for 12 weeks.
The second part of the study investigates the administration of 3 vaccine doses (Weeks 0, 13, 26) then 12 weeks follow‑up on an outpatient basis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Tolerability, Immunogenicity and Efficacy of Multiple PolyPEPI1018 Vaccinations as an Add-on Immunotherapy to the Standard-of-Care Maintenance Therapy in Subjects With Metastatic Colorectal Cancer|
|Actual Study Start Date :||April 9, 2018|
|Estimated Primary Completion Date :||July 30, 2019|
|Estimated Study Completion Date :||December 21, 2019|
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 dominant epitopes from 7 cancer testis antigens (CTAs), which are the most frequently expressed CTAs in colorectal cancer. The 6 peptides were optimized to induce long lasting CRC specific T cell responses.
Biological: PolyPEPI1018 CRC Vaccine
Colorectal Cancer Vaccine
- Incidence of Treatment Related Adverse Events [ Time Frame: 21 days after each vaccinations ]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
- Measure T cell responses [ Time Frame: 12 weeks ]To measure vaccine-induce T cell responses in each study subjects
- Prediction of T cell responses [ Time Frame: 21 days ]Predict vaccine-induced T cells in each study subject using the candidate CDx
- Measure objective tumor responses [ Time Frame: 12 weeks ]CT scans will be performed at screening and weeks 6,12 after each vaccination
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Universiti di Pisa|
|Pisa, PI, Italy|
|Study Chair:||Eva Vegh, MD, MDA||Treos Bio Zrt|