Clinical trial · Interventional
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study: Safety, Toxicity and Immunological Effects of Peritumorally Delivered Immunotherapy in Early-stage Cervical Cancer
NCT06095674CI-TRIAL-00070702ITHACAunknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 antibody balstilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 checkpoint inhibitor and CTLA-4 inhibitor
- description
- Both antibodies will be peritumorally administered in early-stage cervical cancer prior to surgery.
- interventionNames
- Drug: Anti-PD-1 antibody balstilimab
Primary outcomes (1)
- measure
- Dose limiting toxicity
- timeFrame
- 2 years
- description
- Type and severity of side effects according to CTCAE v 5.0.
Secondary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.