ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Not yet enrolling; Phase 1

Conditions: Cervical Cancer

Treatments: Drug: Anti-PD-1 antibody balstilimab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06095674

14244

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

PD-1 checkpoint inhibitor and CTLA-4 inhibitor

Experimental group

Description:

Both antibodies will be peritumorally administered in early-stage cervical cancer prior to surgery.

Treatment:

Drug: Anti-PD-1 antibody balstilimab