PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRGN-2009 plus Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, HPV-Related Carcinoma, HPV-Related Malignancy, Recurrent Cervical Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.
Overview
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.
Detailed description
This is a Phase 2 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 receive PRGN-2009 (5 x 10\^11 PU, subcutaneous injection) every 3 weeks for three administrations, thereafter every 6 weeks, plus pembrolizumab (400 mg IV) every 6 weeks.
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.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Safety of PRGN-2009 in combination with pembrolizumab [Time frame: 1 year]
- Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab [Time frame: 1 year]
- Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab [Time frame: 1 year]
- Time to Response and Duration of Responses following treatment with PRGN-2009 in combination with pembrolizumab [Time frame: 1 year]
- Vector shedding following subcutaneous administration of PRGN-2009 [Time frame: Up to 4 months]
Eligibility criteria
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 confirmed HPV positive disease
- 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
- Prior chemotherapy, targeted therapy within 14 days; monoclonal antibody within 4 weeks; unresolved AEs.
- Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days. HIV eligible with disease control.
- Active hepatitis B (HBsAg+) or hepatitis C (HCV RT-PCR+) within 30 days of enrollment.
- History of non-infectious pneumonitis or interstitial lung disease.
- History of endocrine autoimmune disease (exceptions: treated Graves' disease; hypothyroidism on replacement).
- Live vaccine within 30 days prior to first dose.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- University of Arkansas for Medical Sciences — Little Rock
- National Institute of Health — Bethesda
- University of Washington — Seattle
Identifiers
NCT: NCT06157151 · PRGN-2009-201