RECRUITING

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

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Conditions

Cervical CancerHPV-Related CarcinomaHPV-Related MalignancyRecurrent Cervical CarcinomaMetastatic Cervical CancerHuman Papilloma VirusPembrolizumabTherapeutic VaccineCervix CancerResistance to Checkpoint Inhibitors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This randomized trial will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.

Official Title

A Randomized, Open-label, Two-arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab Monotherapy in Patients with Recurrent or Metastatic Cervical Cancer.

Quick Facts

Study Start:2024-11
Study Completion:2028-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06157151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years and older.
  2. * Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant.
  3. * Must have been treated with pembrolizumab, either as monotherapy or in combination
  4. * Patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting
  5. * Tumors are confirmed positive for PD-L1 and HPV16/18
  6. * Measurable disease that can be accurately measured by RECIST v1.1 criteria
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  8. * Life expectancy ≥ 12 weeks from the time of enrollment.
  9. * Must have adequate organ function
  10. * 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.
  11. * All patients must have the ability to understand and willingness to sign a written informed consent.
  1. * Patients with presence of other active malignancy within 1 year prior to study entry
  2. * Known Central Nervous System (CNS) disease
  3. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  4. * Known history of active tuberculosis (TB, Bacillus tuberculosis).
  5. * Pregnant and lactating women are excluded from this study.
  6. * Patients with a history of solid organ transplant.
  7. * 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.
  8. * Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.

Contacts and Locations

Study Contact

Amy Lankford
CONTACT
3015569900
clinicaltrials@precigen.com

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
National Institute of Health
Bethesda, Maryland, 20892
United States
University of Washington
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Precigen, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2028-01-30

Study Record Updates

Study Start Date2024-11
Study Completion Date2028-01-30

Terms related to this study

Keywords Provided by Researchers

  • Human Papilloma Virus
  • Cervical Cancer
  • Pembrolizumab
  • Therapeutic Vaccine
  • Cervix Cancer
  • Resistance to Checkpoint Inhibitors

Additional Relevant MeSH Terms

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