IVAC-RCC-001: A Personalized Neoantigen Vaccine as Add-on to Standard of Care Checkpoint Inhibitor in Advanced/Metastatic RCC Patients
|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: NCT05641545|
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : December 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Renal Cell Carcinoma||Biological: IVAC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IVAC-RCC-001: A Personalized Neoantigen Vaccine as Add-on to Standard of Care Checkpoint Inhibitor in Advanced/Metastatic RCC Patients|
|Actual Study Start Date :||October 17, 2022|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||November 2025|
Individual peptide vaccination with adjuvant GM-CSF and Imiquimod Intradermal injection of a cocktail of 3-5 individual HLA-binding peptides. Subcutaneous injection of adjuvant GM-CSF at vaccination site. Topical administration of Imiquimod at vaccination site.
IVAC is a personalized peptide vaccine
- Primary endpoint is "success of treatment" defined as a patient without unacceptable toxicity and showing a vaccination-induced T-cell response. [ Time Frame: 120 days ]
Treatment success is defined as a patient without
- unacceptable toxicities (grade 4 according to NCI-CTC) and in whom
- a vaccine-specific response of CD4+ and/or CD8+ T cells could be induced. The primary endpoint will be analyzed after 10 patients have reached visit 10
- To evaluate CD4+ and/or CD8+ T-cell responses over the vaccination period. [ Time Frame: 246 days ]T-cell responses will be measured after completion of the study and will be analyzed with regard to the T-cell responses after 10 vaccinatuions /at day 120.
- To evaluate the event-free survival (EFS) during and after treatment. [ Time Frame: 246 days ]EFS will be assessed on days 120 and 246.
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): NCT05641545
|Contact: Uwe Martens, MDfirstname.lastname@example.org|
|SLK Kliniken Heilbronn, Klinik für Innere Medizin III: Hämatologie, Onkologie, Palliativmedizin||Recruiting|
|Heilbronn, Germany, 74078|
|Contact: Uwe Martens, MD 004971314928000 email@example.com|
|Contact: Josef Huber, MD firstname.lastname@example.org|