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

Launched by PRECIGEN, INC · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with recurrent or metastatic cervical cancer, particularly for those whose cancer has not responded to a previous treatment called pembrolizumab. The trial will compare the effects of combining a new therapy called PRGN-2009 with pembrolizumab against using pembrolizumab alone. The goal is to see if the combination can help patients better than pembrolizumab on its own.

To be eligible for this trial, participants need to be at least 18 years old and have confirmed recurrent or metastatic cervical cancer that has shown resistance to pembrolizumab. They should also have specific tumor characteristics and be in relatively good health, as determined by a performance status scale. Participants can expect to receive either the combination treatment or the standard treatment and will be closely monitored for safety and effectiveness throughout the study. It's important to note that certain conditions, like having another active cancer or severe allergies to the treatment, would prevent someone from joining the trial.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.