Clinical trial · Interventional
PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.
NCT06157151CI-TRIAL-00109203recruitingPhase 2ClinicalTrials.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)
This Phase 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
Conditions
Conditions (5)
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 |
| HPV-Related Carcinoma | Human Papillomavirus-Related Carcinoma | ALIAS | 0.90 |
| HPV-Related Malignancy | Human Papillomavirus-Related Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRGN-2009 plus Pembrolizumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PRGN-2009 plus Pembrolizumab
- description
- PRGN-2009 at a dose of 5 x 10\^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w
- interventionNames
- Biological: PRGN-2009 plus Pembrolizumab
Primary outcomes (1)
- measure
- Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
- timeFrame
- 1 year
- description
- The ORR will be calculated as the combination of subjects achieving a complete response or a partial response per RECIST v1.1. ORR will be calculated and presented with 2-sided 95% confidence interval.
Secondary outcomes (5)
- measure
- Safety of PRGN-2009 in combination with pembrolizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and older. * Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) * Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks. * Subjects must have histologically or cytologically confirmed HPV positive disease * Measurable disease that can be accurately measured by RECIST v1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥ 12 weeks from the time of enrollment. * Must have adequate organ function * Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment. * All patients must have the ability to understand and willingness to sign a written informed consent. Exclusion Criteria: * Prior chemotherapy, targeted therapy within 14 days; monoclonal antibody within 4 weeks; unresolved AEs. * Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days. HIV eligible with disease control. * Active hepatitis B (HBsAg+) or hepatitis C (HCV RT-PCR+) within 30 days of enrollment. * History of non-infectious pneumonitis or interstitial lung disease. * History of endocrine autoimmune disease (exceptions: treated Graves' disease; hypothyroidism on replacement). * Live vaccine within 30 days prior to first dose. * Patients with presence of other active malignancy within 1 year prior to study entry * Known Central Nervous System (CNS) disease * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Known history of active tuberculosis (TB, Bacillus tuberculosis). * Pregnant and lactating women are excluded from this study. * Patients with a history of solid organ transplant. * Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment. * Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.