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PRGN-2009 plus Pembrolizumab

Phase 2

Cervical Cancer | Monoclonal antibody | Oncology |Precigen, Inc.|Last Updated: Apr 23, 2026

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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical trial landscape

PRGN-2009 plus Pembrolizumab · 1 trial · 5 indications

Phase 2 1
NCT06157151PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical CancerCervical Cancer
RECRUITING24 Analytics
PHASE2RECRUITING
PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
Cervical Cancer
NCT0615715124
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Study Endpoints
Primary Endpoints
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.
1 year

The ORR will be calculated as the combination of subjects achieving a complete response or a partial response per RECIST v1.1. ORR will be calculated and presented with 2-sided 95% confidence interval.

Secondary Endpoints
Safety of PRGN-2009 in combination with pembrolizumab
1 year
Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab
1 year
Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRGN-2009 plus PembrolizumabEXPERIMENTALPRGN-2009 at a dose of 5 x 10\^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w
Interventions
NameTypeDescription
PRGN-2009 plus PembrolizumabBIOLOGICALSubjects 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.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Age 18 years and older. * Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) * Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks. * Subjects must have histologically or cytologically confirm...

Countries:United States
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Competitive Landscape -Cervical Cancer 66 trials

Top 20 of 29 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN5PHASE3Volrustomig
Merck & Co., Inc.MRK4PHASE3Sacituzumab Tirumotecan, Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine
Pfizer Inc.PFE3PHASE2tucatinib, trastuzumab, fulvestrant
ImmunityBio IncIBRX2PHASE2N-803, Pembrolizumab
Eli Lilly and CompanyLLY3PHASE1LY4101174
MacroGenics, Inc.MGNX2PHASE2Lorigerlimab
Precigen IncPGEN1PHASE2PRGN-2009 plus Pembrolizumab
Xencor, Inc.XNCR1PHASE2vudalimab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA3PHASE2E7 TCR-T cells, Aldesleukin
Bristol-Myers Squibb CompanyBMY1PHASE1BMS-986340, BMS-936558-01, Docetaxel, Pumitamig
AbbVie, Inc.ABBV1PHASE1IMGN151
Arcus Biosciences, Inc.RCUS1PHASE1AB598, Zimberelimab, Fluorouracil, Leucovorin, Oxaliplatin
Ascendis Pharma A/SASND1PHASE1TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug, TransCon TLR7/8 Agonist, Trastuzumab
Nanobiotix SA Sponsored ADRNBTX1PHASE1NBTXR3, Nivolumab, Pembrolizumab
TScan Therapeutics, Inc.TCRX2PHASE1TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101
Oncolytics Biotech Inc.ONCY1PHASE1Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen
Nurix Therapeutics, Inc.NRIX1PHASE1NX-1607, Paclitaxel
NeOnc Technologies Holdings, Inc.NTHI1PHASE1NEO212, Ipilimumab, Pembrolizumab, Nivolumab, Regorafenib
Aktis Oncology, Inc.AKTS1PHASE1Ac-AKY-1189, Cu-AKY-1189
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT06157151Enrollment: 46 → 24
LOWMay 24, 2026NCT06157151studyFirstPostDate: changed