ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study

NCT ID: NCT06095674

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-01-31

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 checkpoint inhibitor and CTLA-4 inhibitor

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

Group Type: EXPERIMENTAL

Anti-PD-1 antibody balstilimab

Intervention Type: DRUG

Both antibodies will be neoadjuvantly administered around the cervical tumor.

Interventions

Anti-PD-1 antibody balstilimab

Both antibodies will be neoadjuvantly administered around the cervical tumor.

Intervention Type: DRUG

Other Intervention Names

Anti-CTLA-4 antibody botensilimab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

Agenus Inc.

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

C.H. (Stijn) Mom

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Constantijne H Mom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Amsterdam UMC

Amsterdam, , Netherlands

Countries

Netherlands

Central Contacts

Constantijne H Mom, MD, PhD

Role: CONTACT

c.mom@amsterdamumc.nl

+31205669111

Facility Contacts

Constantijne H Mom, MD, PhD

Role: primary

Other Identifiers

14244

Identifier Type: -

Identifier Source: org_study_id