ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Agenus Inc.; Dutch Cancer Society
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• early-stage cervical cancer

• scheduled for (radical) hysterectomy and pelvic lymph node dissection

Exclusion Criteria:

• previous treatment with checkpoint inhibitors

• use of immunosuppressive medication within 28 days of the injection of the study medication

• history of other malignancy