Study on PRGN-2009 and Pembrolizumab Combination vs. Pembrolizumab Alone for Recurrent or Metastatic Cervical Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have cervical cancer that has returned or spread and is resistant to pembrolizumab.
• Previously treated with pembrolizumab, either alone or with other drugs.
• Have received no more than two previous treatments for recurrent or metastatic cancer.
• Tumors must test positive for PD-L1 and HPV16/18.
• Have measurable cancer that can be tracked using standard criteria.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a life expectancy of at least 12 weeks from the start of the study.
• Have adequate organ function as determined by specific medical tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for six months after.
• Must understand the study and agree to sign informed consent.

Exclusion Criteria

• Have another active cancer within the past year.
• Have known disease affecting the central nervous system.
• Have severe allergies to pembrolizumab or its ingredients.
• Have a history of active tuberculosis.
• Are pregnant or breastfeeding.
• Have had a solid organ transplant.
• Are currently in another clinical trial or have used an investigational device recently.
• Are unable to comply with the study's monitoring requirements, as determined by the investigator.