Status:
RECRUITING
PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
Lead Sponsor:
Precigen, Inc
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
HPV-Related Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized trial will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metasta...
Detailed Description
This is a randomized, two-arm study of PRGN-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to part...
Eligibility Criteria
Inclusion
- Age 18 years and older.
- Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant.
- Must have been treated with pembrolizumab, either as monotherapy or in combination
- Patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting
- Tumors are confirmed positive for PD-L1 and HPV16/18
- 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
- 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.
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2028
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06157151
Start Date
March 21 2025
End Date
January 30 2028
Last Update
November 14 2025
Active Locations (3)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
National Institute of Health
Bethesda, Maryland, United States, 20892
3
University of Washington
Seattle, Washington, United States, 98109