Trials / Recruiting

RecruitingNCT06157151

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

A Randomized, Open-label, Two-arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy in Patients With Recurrent or Metastatic Cervical Cancer.

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 46 (estimated)

Sponsor: Precigen, Inc · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	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.
DRUG	Pembrolizumab alone	Subjects randomized will receive IV infusion of pembrolizumab (400 mg) administered every 6 weeks.

Timeline

Start date: 2025-03-21
Primary completion: 2028-01-30
Completion: 2028-01-30
First posted: 2023-12-05
Last updated: 2025-11-14

Locations

3 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06157151. Inclusion in this directory is not an endorsement.