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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Precigen, Inc
Study ID
NCT06157151
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PRGN-2009 plus Pembrolizumab — BIOLOGICAL
    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.

Study Details

This Phase 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.

Key Dates

Start date
Nov 11, 2025
Status verified
Apr 2026
Primary completion
Nov 11, 2026
Completion
Nov 30, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer. [ Time Frame: 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Nou Yang
[email protected]
501-320-7749
Michael Birrer, MD, PhD (PRINCIPAL_INVESTIGATOR)
National Institute of HealthBethesdaMaryland20892
Shannon Householder
[email protected]
University of WashingtonSeattleWashington98109
John Liao, MD
[email protected]
866-932-8588

Find similar trials in Little Rock, AR

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Arkansas for Medical Sciences· Little Rock, ARNational Institute of Health· Bethesda, MDUniversity of Washington· Seattle, WA

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