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Trial Title:
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
NCT ID:
NCT06095674
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Antibodies
Immunoglobulins
Conditions: Keywords:
Immune therapy
Check point inhibitor
Peritumoral administration
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Anti-PD-1 antibody balstilimab
Description:
Both antibodies will be neoadjuvantly administered around the cervical tumor.
Arm group label:
PD-1 checkpoint inhibitor and CTLA-4 inhibitor
Other name:
Anti-CTLA-4 antibody botensilimab
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Country:
Netherlands
Contact:
Last name:
Constantijne H Mom, MD, PhD
Investigator:
Last name:
Constantijne H Mom, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Tanja De Gruijl, Prof
Email:
Principal Investigator
Start date:
January 2024
Completion date:
January 2026
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Collaborator:
Agency:
Dutch Cancer Society
Agency class:
Other
Collaborator:
Agency:
Agenus Inc.
Agency class:
Industry
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095674
