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Clinical Trial Summary

The ITHACA study is a phase I study evaluating the safety and toxicity of a peritumorally injected PD-1 checkpoint inhibitor, in combination with a multifunctional CTLA-4 inhibitor, in early-stage cervical cancer.


Clinical Trial Description

In this single arm, open label phase I study, the investigators will study the safety and toxicity of the combination of a PD-1 checkpoint inhibitor and a multifunctional CTLA-4 inhibitor when injected peritumorally prior to surgery in early-stage cervical cancer. Additional objectives are to describe dose limiting toxicities, to determine the maximum tolerated doses and to study the effects on the tumor and lymph node microenvironment, and on immune subsets in peripheral blood. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06095674
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Constantijne H Mom, MD, PhD
Phone +31205669111
Email c.mom@amsterdamumc.nl
Status Not yet recruiting
Phase Phase 1
Start date January 2024
Completion date January 2026

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