ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study (ITHACA)

October 17, 2023 updated by: C.H. (Stijn) Mom, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC
        • Contact:
          • Constantijne H Mom, MD, PhD
        • Principal Investigator:
          • Constantijne H Mom, MD, PhD
        • Principal Investigator:
          • Tanja De Gruijl, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity
Time Frame: 2 years
Type and severity of side effects according to CTCAE v 5.0.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose
Time Frame: 2 years
The highest dose administered without unacceptable toxicity
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Agenus Inc.
Dutch Cancer Society

Investigators

  • Principal Investigator: Constantijne H Mom, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14244

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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