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

Sponsor: Precigen, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06157151

Patient View

This trial assesses PRGN-2009 plus pembrolizumab versus pembrolizumab alone in pembrolizumab-resistant cervical cancer. Eligible patients are 18+, with PD-L1 and HPV16/18 positive tumors, ECOG 0-1, and measurable disease. Interventions include PRGN-2009 SC every 3-6 weeks and pembrolizumab IV every 6 weeks. Participants must have adequate organ function and use contraception if applicable.

Patient Parameters

Program Overview

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 metastatic cervical cancer.

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 participate in the study will be randomized 1:1 to receive a combination of PRGN-2009, plus pembrolizumab, or to receive pembrolizumab alone.

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.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.