Back to resultsImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study (ITHACA)
Primary Purpose
Cervical Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Anti-PD-1 antibody balstilimab
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Immune therapy, Check point inhibitor, Peritumoral administration
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
Sites / Locations
- Amsterdam UMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PD-1 checkpoint inhibitor and CTLA-4 inhibitor
Arm Description
Both antibodies will be peritumorally administered in early-stage cervical cancer prior to surgery.
Outcomes
Primary Outcome Measures
Dose limiting toxicity
Type and severity of side effects according to CTCAE v 5.0.
Secondary Outcome Measures
Maximum tolerated dose
The highest dose administered without unacceptable toxicity
Full Information
NCT ID
NCT06095674
First Posted
September 4, 2023
Last Updated
October 17, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Dutch Cancer Society, Agenus Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06095674
Brief Title
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
Acronym
ITHACA
Official Title
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study: Safety, Toxicity and Immunological Effects of Peritumorally Delivered Immunotherapy in Early-stage Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Dutch Cancer Society, Agenus Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Immune therapy, Check point inhibitor, Peritumoral administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD-1 checkpoint inhibitor and CTLA-4 inhibitor
Arm Type
Experimental
Arm Description
Both antibodies will be peritumorally administered in early-stage cervical cancer prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Anti-PD-1 antibody balstilimab
Other Intervention Name(s)
Anti-CTLA-4 antibody botensilimab
Intervention Description
Both antibodies will be neoadjuvantly administered around the cervical tumor.
Primary Outcome Measure Information:
Title
Dose limiting toxicity
Description
Type and severity of side effects according to CTCAE v 5.0.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Maximum tolerated dose
Description
The highest dose administered without unacceptable toxicity
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Constantijne H Mom, MD, PhD
Phone
+31205669111
Email
c.mom@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantijne H Mom, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantijne H Mom, MD, PhD
First Name & Middle Initial & Last Name & Degree
Constantijne H Mom, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tanja De Gruijl, Prof
12. IPD Sharing Statement
Learn more about this trial
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
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