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NCT06095674 Clinical Trial

ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study

Cervical Cancer Clinical Trial

— ITHACA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06095674
Other study ID # 14244
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date January 2024
Est. completion date January 2026

Study information
Verified date October 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Constantijne H Mom, MD, PhD
Phone +31205669111
Email c.mom@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Anti-PD-1 antibody balstilimab
Both antibodies will be neoadjuvantly administered around the cervical tumor.

Locations
Country Name City State
Netherlands Amsterdam UMC Amsterdam

Sponsors (3)
Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Agenus Inc., Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose limiting toxicity Type and severity of side effects according to CTCAE v 5.0. 2 years
Secondary Maximum tolerated dose The highest dose administered without unacceptable toxicity 2 years
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