A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak® in Recurrent or Metastatic Cervical Cancer

Summary

TIVDAK is used for the treatment of recurrent or metastatic cervical cancer. Ocular AEs occurred in approximately half of participants with cervical cancer treated with Tivdak across clinical studies and are mostly low-grade, non-serious, and manageable. The purpose of the study is to further characterize the incidence and severity of Tivdak-related ocular events with prospectively pre-specified, scheduled ocular assessments in patients receiving Tivdak for recurrent/metastatic cervical cancer.

To be included in GOG-3116, participants must be / have:  

• Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
• Treating physician has determined that treatment with Tivdak is appropriate for the participant according to U.S. Prescribing Information
• Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
• Must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site
• Must agree to use effective contraception according to the U.S. Prescribing Information

To be included in GOG-3116, participants must not be / have: 

• Active ocular disease at baseline per investigator assessment
• Previous treatment with Tivdak
• Previous administration of an investigational drug within 30 days
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator

Keywords

ADC; Cancer; Chemotherapy; Gynecologic oncology; Ovarian cancer