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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05641545
Other study ID # IVAC-RCC-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 17, 2022
Est. completion date November 2025

Study information

Verified date November 2022
Source SLK Kliniken Heilbronn GmbH
Contact Uwe Martens, MD
Phone 004971314928000
Email uwe.martens@slk-kliniken.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a monocenter, single-arm, prospective phase Ib trial, designed to evaluate the safety, clinical toxicity and in vivo immunological effects of a patient-individualized peptide vaccination added to standard of care checkpoint blockade (nivolumab) in adult patients with metastatic/advanced renal cell carcinoma who experienced at least stable disease after four cycles of standard of care immune therapy (ipilimumab/nivolumab).


Description:

The aim of this clinical study is to evaluate the feasibility and safety of an individualized peptide vaccination approach in patients with advanced renal cell carcinoma who experienced at least stable disease after four cycles of standard of care immune therapy (ipilimumab/nivolumab). For this purpose, tumor-specific mutations are analyzed by comparative exome sequencing of tumor and healthy reference tissue. In a second step, HLA-binding (human leukocyte antigen-binding) peptides derived from mutated protein sequences are selected for vaccination. The peptides are administered as a vaccination cocktail with adjuvant GM-CSF and Imiquimod over a course of 9 months and a total of 16 vaccinations. Primary objective is the de novo induction of a specific T cell response without unacceptable toxicity.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
IVAC
IVAC is a personalized peptide vaccine

Locations

Country Name City State
Germany SLK Kliniken Heilbronn, Klinik für Innere Medizin III: Hämatologie, Onkologie, Palliativmedizin Heilbronn

Sponsors (1)

Lead Sponsor Collaborator
SLK Kliniken Heilbronn GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary endpoint is "success of treatment" defined as a patient without unacceptable toxicity and showing a vaccination-induced T-cell response. 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
120 days
Secondary To evaluate CD4+ and/or CD8+ T-cell responses over the vaccination period. 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. 246 days
Secondary To evaluate the event-free survival (EFS) during and after treatment. EFS will be assessed on days 120 and 246. 246 days
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