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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.