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New treatment option for Cervical Cancer
Official title PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
ClinicalTrials.gov ID: NCT06157151
What this study is testing
What is PRGN-2009 plus Pembrolizumab?
PRGN-2009 plus Pembrolizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- people must have histologically or cytologically confirmed HPV positive disease
- Measurable disease that can be accurately measured by RECIST v1.1 criteria
You likely can't join if
- 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.
See the full eligibility 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.
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Bethesda, Maryland, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Bethesda, Maryland, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.