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

PHASE2RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

March 21, 2025

Primary Completion Date

January 30, 2028

Study Completion Date

January 30, 2028

Conditions
Cervical CancerHPV-Related CarcinomaHPV-Related MalignancyRecurrent Cervical CarcinomaMetastatic Cervical Cancer
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.

Trial Locations (3)

20892

RECRUITING

National Institute of Health, Bethesda

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

98109

ACTIVE_NOT_RECRUITING

University of Washington, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Precigen, Inc

INDUSTRY