Exploring TIVDAK for Women with Recurrent Cervical Cancer
A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER
This study is testing a treatment called TIVDAK for women whose cervical cancer has come back after chemotherapy to see how it affects their health, especially their eyes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 93 sites (Phoenix, Arizona and 92 other locations) |
| Trial ID | NCT06952660 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of TIVDAK, a treatment for cervical cancer that has returned after chemotherapy. Participants will receive TIVDAK infusions every three weeks and undergo eye assessments at various stages throughout the treatment. The primary goal is to evaluate potential side effects, particularly those related to the eyes, in women with recurrent or metastatic cervical cancer. Participants must not have any active eye issues and must be willing to undergo the required ocular tests.
Who should consider this trial
Good fit: Ideal candidates are women with recurrent or metastatic cervical cancer who have experienced disease progression after chemotherapy and are willing to undergo eye assessments.
Not a fit: Patients with active ocular diseases or those who have previously received TIVDAK will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of TIVDAK for women with recurrent cervical cancer.
How similar studies have performed: Other studies have shown promise with TIVDAK in similar patient populations, indicating a potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy 2. Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information 3. Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate 4. 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 5. Must agree to use effective contraception according to the US Prescribing Information Exclusion criteria: 1. Active ocular disease at baseline per investigator assessment 2. Previous treatment with Tivdak 3. Previous administration of an investigational drug within 30 days 4. 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 this trial is running
Phoenix, Arizona and 92 other locations
- HonorHealth Cancer Care - Biltmore - AZCCC Imaging — Phoenix, Arizona, United States (Recruiting)
- HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy — Phoenix, Arizona, United States (Recruiting)
- Sonora Quest Laboratories, LLC — Phoenix, Arizona, United States (Recruiting)
- South West Medical Imaging (SMIL) — Phoenix, Arizona, United States (Recruiting)
- Schwartz Laser Eye Center — Scottsdale, Arizona, United States (Recruiting)
- Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy — Scottsdale, Arizona, United States (Recruiting)
- HonorHealth Cancer Care - Tempe - AZCCC Imaging — Tempe, Arizona, United States (Recruiting)
- Mount Sinai Comprehensive Cancer Center - Aventura — Aventura, Florida, United States (Recruiting)
- Florida Cancer Specialists — Bonita Springs, Florida, United States (Recruiting)
- Florida Cancer Specialists — Bradenton, Florida, United States (Recruiting)
- Florida Cancer Specialists — Cape Coral, Florida, United States (Recruiting)
- Broward Health Coral Springs — Coral Springs, Florida, United States (Recruiting)
- Florida Cancer Specialists — Daytona Beach, Florida, United States (Recruiting)
- Broward Health North — Deerfield Beach, Florida, United States (Recruiting)
- Florida Cancer Specialists — Fleming Island, Florida, United States (Recruiting)
- Broward Health Imperial Point — Fort Lauderdale, Florida, United States (Recruiting)
- Broward Health Medical Center — Fort Lauderdale, Florida, United States (Recruiting)
- Florida Cancer Specialists — Fort Myers, Florida, United States (Recruiting)
- Florida Cancer Specialists — Fort Myers, Florida, United States (Recruiting)
- HCA Mercy Hospital — Miami, Florida, United States (Recruiting)
- Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States (Recruiting)
- Mount Sinai Medical Center of Florida, Inc — Miami Beach, Florida, United States (Recruiting)
- Florida Cancer Specialists — N. Venice, Florida, United States (Recruiting)
- Florida Cancer Specialists — Naples, Florida, United States (Recruiting)
- Orlando Health Cancer Institute — Orlando, Florida, United States (Recruiting)
- Orlando Health Orlando Regional Medical Center — Orlando, Florida, United States (Recruiting)
- Orlando Health Winnie Palmer Hospital for Women & Babies — Orlando, Florida, United States (Recruiting)
- Florida Cancer Specialists — Port Charlotte, Florida, United States (Recruiting)
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- Florida Cancer Specialists — Stuart, Florida, United States (Recruiting)
- Florida Cancer Specialists — Wellington, Florida, United States (Recruiting)
- Florida Cancer Specialists — West Palm Beach, Florida, United States (Recruiting)
- Grady Health System Correll Pavilion — Atlanta, Georgia, United States (Recruiting)
- Grady Memorial Hospital Investigational Drug Service — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- The Emory Clinic — Atlanta, Georgia, United States (Recruiting)
- Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Georgia Cancer Center at Augusta University — Augusta, Georgia, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- Rush University Medical Center, Ophthalmology — Chicago, Illinois, United States (Recruiting)
- Illinois Eye Center — Peoria, Illinois, United States (Recruiting)
- OSF Saint Francis Medical Center (OSF SFMC) — Peoria, Illinois, United States (Recruiting)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Recruiting)
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
- Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States (Recruiting)
- Norton Cancer Institute - Downtown — Louisville, Kentucky, United States (Recruiting)
- Norton Hospital — Louisville, Kentucky, United States (Recruiting)
- Norton Cancer Institute St Matthews Campus — Louisville, Kentucky, United States (Recruiting)
- Norton Women's and Children's Hospital — Louisville, Kentucky, United States (Recruiting)
+43 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.