ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
- Registration Number
- NCT06095674
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- early-stage cervical cancer
- scheduled for (radical) hysterectomy and pelvic lymph node dissection
- previous treatment with checkpoint inhibitors
- use of immunosuppressive medication within 28 days of the injection of the study medication
- history of other malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PD-1 checkpoint inhibitor and CTLA-4 inhibitor Anti-PD-1 antibody balstilimab Both antibodies will be peritumorally administered in early-stage cervical cancer prior to surgery.
- Primary Outcome Measures
Name Time Method Dose limiting toxicity 2 years Type and severity of side effects according to CTCAE v 5.0.
- Secondary Outcome Measures
Name Time Method Maximum tolerated dose 2 years The highest dose administered without unacceptable toxicity
Trial Locations
- Locations (1)
Amsterdam UMC
🇳🇱Amsterdam, Netherlands