Cervical Cancer
Conditions
Keywords
Immune therapy, Check point inhibitor, Peritumoral administration
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.
Interventions
DRUGAnti-PD-1 antibody balstilimab
Both antibodies will be neoadjuvantly administered around the cervical tumor.
Sponsors
Dutch Cancer Society
Agenus Inc.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity | 2 years | Type and severity of side effects according to CTCAE v 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | 2 years | The highest dose administered without unacceptable toxicity |
Countries
Netherlands
Contacts
Primary ContactConstantijne H Mom, MD, PhD
Outcome results
None listed