Status:
NOT_YET_RECRUITING
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Dutch Cancer Society
Agenus Inc.
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 cer...
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 injecte...
Eligibility Criteria
Inclusion
- early-stage cervical cancer
- scheduled for (radical) hysterectomy and pelvic lymph node dissection
Exclusion
- previous treatment with checkpoint inhibitors
- use of immunosuppressive medication within 28 days of the injection of the study medication
- history of other malignancy
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06095674
Start Date
January 1 2024
End Date
January 1 2026
Last Update
October 23 2023
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, Netherlands