Spots Global Cancer Trial Database for ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
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Trial Identification
Brief Title: ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
Official Title: ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study: Safety, Toxicity and Immunological Effects of Peritumorally Delivered Immunotherapy in Early-stage Cervical Cancer
Study ID: NCT06095674
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Amsterdam UMC, Amsterdam, , Netherlands
Contact Details
Name: Constantijne H Mom, MD, PhD
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: PRINCIPAL_INVESTIGATOR
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