Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer

Recruiting now · Phase 4

Conditions studied: Cervical Cancer

In brief

TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease. * This study is seeking for participants who: Are willing to take all the required eye tests * Have not received TIVDAK before * Do not have any active eye issues. Participants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages: * before starting the treatment, * before each of the first 9 infusions * then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.

Key facts

Study ID

NCT06952660

Run by

Pfizer

People needed

100

Starts

2025-05-07

Expected to finish

2028-12-13

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 US 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 US Prescribing Information

You may not qualify if…

• 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'

Where it is running

• HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy — Phoenix, Arizona, United States (enrolling)
• HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care -Biltmore — Phoenix, Arizona, United States (enrolling)
• Sonora Quest Laboratories, LLC — Phoenix, Arizona, United States (enrolling)
• South West Medical Imaging (SMIL) — Phoenix, Arizona, United States (enrolling)
• Schwartz Laser Eye Center — Scottsdale, Arizona, United States (enrolling)
• Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy — Scottsdale, Arizona, United States (enrolling)
• HonorHealth Cancer Care - Tempe - AZCCC Imaging — Tempe, Arizona, United States (enrolling)
• HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care - Tempe — Tempe, Arizona, United States (enrolling)
• AdventHealth Hematology and Oncology Denver — Denver, Colorado, United States (enrolling)
• AdventHealth Medical Group Gynecologic Oncology at Porter — Denver, Colorado, United States (enrolling)
• Mount Sinai Comprehensive Cancer Center - Aventura — Aventura, Florida, United States (enrolling)
• Florida Cancer Specialists — Bonita Springs, Florida, United States (enrolling)
• Florida Cancer Specialists — Bradenton, Florida, United States (enrolling)
• Florida Cancer Specialists — Cape Coral, Florida, United States (enrolling)
• Broward Health Coral Springs — Coral Springs, Florida, United States (enrolling)
• Florida Cancer Specialists — Daytona Beach, Florida, United States (enrolling)
• Broward Health North — Deerfield Beach, Florida, United States (enrolling)
• Florida Cancer Specialists — Fleming Island, Florida, United States (enrolling)
• Broward Health Imperial Point — Fort Lauderdale, Florida, United States (enrolling)
• Broward Health Medical Center — Fort Lauderdale, Florida, United States (enrolling)
• Florida Cancer Specialists — Fort Myers, Florida, United States (enrolling)
• Florida Cancer Specialists — Fort Myers, Florida, United States (enrolling)
• HCA Mercy Hospital — Miami, Florida, United States (enrolling)
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States (enrolling)
• HonorHealth Cancer Care - Biltmore - AZCCC Imaging — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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