NCT06095674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

September 4, 2023

Last Update Submit

October 17, 2023

Conditions

Cervical Cancer

Keywords

Immune therapyCheck point inhibitorPeritumoral administration

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity

    Type and severity of side effects according to CTCAE v 5.0.

    2 years

Secondary Outcomes (1)

  • Maximum tolerated dose

    2 years

Study Arms (1)

PD-1 checkpoint inhibitor and CTLA-4 inhibitor

EXPERIMENTAL

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

Drug: Anti-PD-1 antibody balstilimab

Interventions

Anti-PD-1 antibody balstilimabDRUG

Both antibodies will be neoadjuvantly administered around the cervical tumor.

Also known as: Anti-CTLA-4 antibody botensilimab
PD-1 checkpoint inhibitor and CTLA-4 inhibitor

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • early-stage cervical cancer
  • scheduled for (radical) hysterectomy and pelvic lymph node dissection

You may not qualify if:

  • previous treatment with checkpoint inhibitors
  • use of immunosuppressive medication within 28 days of the injection of the study medication
  • history of other malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Constantijne H Mom, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Constantijne H Mom, MD, PhD

CONTACT

+31205669111c.mom@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 4, 2023

First Posted

October 23, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

NL(1)