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

Purpose

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.

Conditions

  • Cervical Cancer
  • HPV-Related Carcinoma
  • HPV-Related Malignancy
  • Recurrent Cervical Carcinoma
  • Metastatic Cervical Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is an open-label, randomized study.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PRGN-2009 plus Pembrolizumab 		PRGN-2009 at a dose of 5 x 10^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w
  • 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.
Active Comparator
Pembrolizumab alone 		Pembrolizumab, 400mg q6w
  • Drug: Pembrolizumab alone
    Subjects randomized will receive IV infusion of pembrolizumab (400 mg) administered every 6 weeks.

Recruiting Locations

National Institute of Health
Bethesda, Maryland 20892
Contact:
Erica Redmond
erica.redmond@nih.gov

More Details

NCT ID
NCT06157151
Status
Recruiting
Sponsor
Precigen, Inc

Study Contact

Amy Lankford
3015569900
clinicaltrials@precigen.com

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.