Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06157151
PHASE2

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

Sponsor: Precigen, Inc

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2025-03-21

Completion Date

2028-01-30

Last Updated

2025-11-14

Healthy Volunteers

No

Interventions

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.

Locations (3)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

National Institute of Health

Bethesda, Maryland, United States

University of Washington

Seattle, Washington, United States