NCT06095674

ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study

ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study: Safety, Toxicity and Immunological Effects of Peritumorally Delivered Immunotherapy in Early-stage Cervical Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Anti-PD-1 antibody balstilimab	Both antibodies will be neoadjuvantly administered around the cervical tumor.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: Netherlands