ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study

Sponsor

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

Overall Status

Not yet recruiting

CT.gov ID

NCT06095674

Collaborator

Dutch Cancer Society (Other), Agenus Inc. (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: Anti-PD-1 antibody balstilimab	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PD-1 checkpoint inhibitor and CTLA-4 inhibitor Both antibodies will be peritumorally administered in early-stage cervical cancer prior to surgery.	Drug: Anti-PD-1 antibody balstilimab Both antibodies will be neoadjuvantly administered around the cervical tumor. Other Names: Anti-CTLA-4 antibody botensilimab

Arm

Intervention/Treatment

Experimental: PD-1 checkpoint inhibitor and CTLA-4 inhibitor

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

Drug: Anti-PD-1 antibody balstilimab

Both antibodies will be neoadjuvantly administered around the cervical tumor.

Other Names:

Anti-CTLA-4 antibody botensilimab

Outcome Measures

Primary Outcome Measures

Dose limiting toxicity [2 years]
Type and severity of side effects according to CTCAE v 5.0.

Secondary Outcome Measures

Maximum tolerated dose [2 years]
The highest dose administered without unacceptable toxicity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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