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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Both antibodies will be neoadjuvantly administered around the cervical tumor.
Amsterdam UMC
Amsterdam, Netherlands
Dose limiting toxicity
Type and severity of side effects according to CTCAE v 5.0.
Time frame: 2 years
Maximum tolerated dose
The highest dose administered without unacceptable toxicity
Time frame: 2 years
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