Recruiting
Phase 2
PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
Condition(s) studied
Cervical CancerHPV-Related CarcinomaHPV-Related MalignancyRecurrent Cervical CarcinomaMetastatic Cervical Cancer
Investigational drug(s) / intervention(s)
PRGN-2009 plus Pembrolizumab: Subjects randomized will receive PRGN-2009 (5 x 10\^11 PU, subcutaneous (SC) injection) every 3 weeks for three administrations, thereafter subjects will continue to receive PRGN-2009 administrations every 6 weeks. Pembrolizumab will be administered concurrently as intravenous (IV) infusion (400 mg) every 6 weeks.
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- 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. — 1 year
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.
Trial sites (3)
| Facility | City | Region | Status |
| University of Arkansas for Medical Sciences |
Little Rock |
Arkansas |
Recruiting |
| National Institute of Health |
Bethesda |
Maryland |
Recruiting |
| University of Washington |
Seattle |
Washington |
Recruiting |
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