PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer

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.

Conditions6

Interventions2

Locations3 sites

Find trials near these locations

Browse More Trials