Combination treatment for recurrent or metastatic cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial evaluates the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with recurrent or metastatic cervical cancer who are resistant to pembrolizumab. Participants will be randomly assigned to receive either the combination treatment or pembrolizumab alone. The study aims to determine if the addition of PRGN-2009 can improve outcomes for patients who have already shown resistance to standard pembrolizumab therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• National Institute of Health
  Bethesda, Maryland, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Amy Lankford
• Email: clinicaltrials@precigen.com
• Phone: 3015569900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Immunotherapy using E7 TCR-T cells for HPV-related cancers

  This study is testing a new immunotherapy using E7 TCR-T cells to see if it can help people with advanced HPV-related cancers like cervical and throat cancer feel better and improve their health.

  Recruiting at 3 sites Phase 2 Rutgers, The State University of New Jersey · Bethesda, Maryland and 2 other locations · NCT05686226

• E7 T-cell therapy for advanced HPV-related cancers

  This study is testing a new treatment using specially modified immune cells to see if it can help people with advanced cancers linked to HPV feel better and live longer.

  Recruiting at 2 sites Phase 1/2 Rutgers, The State University of New Jersey · New Brunswick, New Jersey and 1 other locations · NCT05639972

• Combination therapy of pembrolizumab and lenvatinib for advanced cervical cancer

  This study is testing if a combination of two drugs, pembrolizumab and lenvatinib, can help patients with advanced cervical cancer who haven't had success with other treatments.

  Recruiting at 3 sites Phase 2 Georgetown University · Washington D.C., District of Columbia and 3 other locations · NCT04865887

• Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

  This registry follows people with persistent, recurrent, or metastatic cervical cancer who are treated with pembrolizumab-containing regimens to see how well it works in real-world care.

  Recruiting at 3 sites Phase 4 University Medical Center Groningen · Amsterdam and 10 other locations · NCT07645625

• Sacituzumab tirumotecan plus pembrolizumab as first-line maintenance for metastatic cervical cancer

  This trial tests whether adding the antibody-drug conjugate sacituzumab tirumotecan to pembrolizumab (with or without bevacizumab) as maintenance treatment can help people with metastatic cervical cancer live longer or keep the cancer from growing.

  Recruiting at 191 sites Phase 3 Merck Sharp & Dohme LLC · Birmingham, Alabama and 190 other locations · NCT07216703

• BL-B01D1 plus pembrolizumab, with or without bevacizumab, for recurrent or metastatic cervical and endometrial cancer

  This trial will try a combination of BL-B01D1 and pembrolizumab, with or without bevacizumab, in adults with recurrent or metastatic cervical or endometrial cancer to see if it shrinks tumors or controls the disease.

  Recruiting Phase 2 Sichuan Baili Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality · NCT07054567

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.