PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
Purpose
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
- Cervical Cancer
- HPV-Related Carcinoma
- HPV-Related Malignancy
- Recurrent Cervical Carcinoma
- Metastatic Cervical Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is an open-label, randomized study.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PRGN-2009 plus Pembrolizumab |
PRGN-2009 at a dose of 5 x 10^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
National Institute of Health
Bethesda, Maryland 20892
Bethesda, Maryland 20892
University of Washington
Seattle, Washington 98109
Seattle, Washington 98109
More Details
- NCT ID
- NCT06157151
- Status
- Recruiting
- Sponsor
- Precigen, Inc
Detailed Description
This is a Phase 2 study of PRGN-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to participate in the study will receive PRGN-2009 (5 x 10^11 PU, subcutaneous injection) every 3 weeks for three administrations, thereafter every 6 weeks, plus pembrolizumab (400 mg IV) every 6 weeks.