PolyPEPI1018 Vaccine and CDx for the Treatment of Metastatic Colorectal Cancer (OBERTO) (OBERTO)
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|ClinicalTrials.gov Identifier: NCT03391232|
Recruitment Status : Completed
First Posted : January 5, 2018
Results First Posted : April 14, 2022
Last Update Posted : May 26, 2022
|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)|
|Actual Enrollment :||11 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 :||May 3, 2018|
|Actual Primary Completion Date :||July 17, 2019|
|Actual Study Completion Date :||July 17, 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
- Number of Participants With Treatment Related Adverse Events [ Time Frame: from 1st vaccination to 21 days after last vaccinations, up to 41 weeks ]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
- Number of Participants Having T Cell Immune Response [ Time Frame: 12 weeks ]Measured CD4+ and CD8+ T cell responses from each subject for each antigen of the vaccine
- Number of Predicted Antigen Specific T Cell Responses Per Patient [ Time Frame: 21 days ]Epitopes restricted to multiple HLA class I alleles (Personal Epitope, PEPI) of a subject were predicted. PEPIs determined for each vaccine antigen can predict the antigen-specific T cell responses for each patient.
- Number of Participants With Objective Tumor Responses - Objective Response Rate (RECIST v1.1) [ Time Frame: 12 weeks ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
CT scans were performed at screening and weeks 6,12 after each vaccination. The objective response were based on for each subject's last CT scan evaluation.
- Number of Participants With Objective Tumor Responses - Disease Control Rate (Best Overall Response is Partial Response or Stable Disease) [ Time Frame: 12 weeks ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) <30% increase compare to smallest sum of the longest diameter of target lesions.
CT scans were performed at screening and weeks 6,12 after each vaccination. The DCR were counted as the best response (PR or SD) for each subject's during the trial.
- Number of Participants Having Induced Recruitment of TILs [ Time Frame: Last visit, up to 38 weeks ]Assessments of TILs was performed using IHC (Immunoscore CR) CD3/CD8 testing on liver biopsy tissue samples obtained from subjects during a time course from baseline until the Last Visit. The CD3+ and CD8+ cell densities were determined in the core tumor and invasive margin using Immunohistochemistry (IHC) staining followed by digital pathology.
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|