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| Name | Class |
|---|---|
| Genmab | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tisotumab vedotin | Experimental | Participants will receive tisotumab vedotin by IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVDAK | Drug | 2 mg/kg once every 3 weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Type, incidence and severity of ocular adverse events (AEs) | 90 days after the last dose of tisotumab vedotin |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of ocular AEs | 90 days after the last dose of tisotumab vedotin | |
| Time to onset of ocular AEs | 90 days after the last dose of tisotumab vedotin | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Cancer Care - Biltmore - AZCCC Imaging | Recruiting | Phoenix | Arizona | 85016 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Incidence of serious adverse events (SAEs) |
| 90 days after the last dose of tisotumab vedotin |
| AEs leading to dose modifications including treatment discontinuation | 90 days after the last dose of tisotumab vedotin |
| HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy |
| Recruiting |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Sonora Quest Laboratories, LLC | Recruiting | Phoenix | Arizona | 85034 | United States |
| South West Medical Imaging (SMIL) | Recruiting | Phoenix | Arizona | 85258 | United States |
| Schwartz Laser Eye Center | Recruiting | Scottsdale | Arizona | 85260 | United States |
| Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy | Recruiting | Scottsdale | Arizona | 85260 | United States |
| HonorHealth Cancer Care - Tempe - AZCCC Imaging | Recruiting | Tempe | Arizona | 85284 | United States |
| Mount Sinai Comprehensive Cancer Center - Aventura | Recruiting | Aventura | Florida | 33180 | United States |
| Florida Cancer Specialists | Recruiting | Bonita Springs | Florida | 34135 | United States |
| Florida Cancer Specialists | Recruiting | Bradenton | Florida | 34211 | United States |
| Florida Cancer Specialists | Recruiting | Cape Coral | Florida | 33909 | United States |
| Broward Health Coral Springs | Recruiting | Coral Springs | Florida | 33065 | United States |
| Florida Cancer Specialists | Recruiting | Daytona Beach | Florida | 32117 | United States |
| Broward Health North | Recruiting | Deerfield Beach | Florida | 33064 | United States |
| Florida Cancer Specialists | Recruiting | Fleming Island | Florida | 32003 | United States |
| Broward Health Imperial Point | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
| Broward Health Medical Center | Recruiting | Fort Lauderdale | Florida | 33316 | United States |
| Florida Cancer Specialists | Recruiting | Fort Myers | Florida | 33905 | United States |
| Florida Cancer Specialists | Recruiting | Fort Myers | Florida | 33908 | United States |
| HCA Mercy Hospital | Recruiting | Miami | Florida | 33133 | United States |
| Mount Sinai Comprehensive Cancer Center | Recruiting | Miami Beach | Florida | 33140 | United States |
| Mount Sinai Medical Center of Florida, Inc | Recruiting | Miami Beach | Florida | 33140 | United States |
| Florida Cancer Specialists | Recruiting | N. Venice | Florida | 34275 | United States |
| Florida Cancer Specialists | Recruiting | Naples | Florida | 34102 | United States |
| Orlando Health Cancer Institute | Recruiting | Orlando | Florida | 32806 | United States |
| Orlando Health Orlando Regional Medical Center | Recruiting | Orlando | Florida | 32806 | United States |
| Orlando Health Winnie Palmer Hospital for Women & Babies | Recruiting | Orlando | Florida | 32806 | United States |
| Florida Cancer Specialists | Recruiting | Port Charlotte | Florida | 33980 | United States |
| Florida Cancer Specialists | Recruiting | Sarasota | Florida | 34236 | United States |
| Florida Cancer Specialists | Recruiting | Stuart | Florida | 34994 | United States |
| Florida Cancer Specialists | Recruiting | Wellington | Florida | 33414 | United States |
| Florida Cancer Specialists | Recruiting | West Palm Beach | Florida | 33401 | United States |
| Grady Health System Correll Pavilion | Recruiting | Atlanta | Georgia | 30303 | United States |
| Grady Memorial Hospital Investigational Drug Service | Recruiting | Atlanta | Georgia | 30303 | United States |
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| The Emory Clinic | Recruiting | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
| Georgia Cancer Center at Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60607 | United States |
| Rush University Medical Center, Ophthalmology | Recruiting | Chicago | Illinois | 60612 | United States |
| Illinois Eye Center | Recruiting | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Medical Center (OSF SFMC) | Recruiting | Peoria | Illinois | 61637 | United States |
| Indiana University Health University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Sidney & Lois Eskenazi Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Norton Cancer Institute - Downtown | Recruiting | Louisville | Kentucky | 40202 | United States |
| Norton Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
| Norton Cancer Institute St Matthews Campus | Recruiting | Louisville | Kentucky | 40207 | United States |
| Norton Women's and Children's Hospital | Recruiting | Louisville | Kentucky | 40207 | United States |
| University Medical Center - New Orleans | Recruiting | New Orleans | Louisiana | 70112 | United States |
| Trials365, LLC | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Willis Knighton Cancer Center | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Willis Knighton Physician Network - Hematology/Oncology | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Willis Knighton Physician Network/Gynecologic Oncology Associates | Recruiting | Shreveport | Louisiana | 71103 | United States |
| WK Eye Institute North | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Willis Knighton Physician Network/Gynecologic Oncology Associates | Recruiting | Shreveport | Louisiana | 71118 | United States |
| M Health Fairview Clinics and Specialty Center | Recruiting | Burnsville | Minnesota | 55337 | United States |
| M Health Fairview Clinics and Surgery Center | Recruiting | Edina | Minnesota | 55435 | United States |
| M Health Fairview Clinics and Surgery Center | Recruiting | Maple Grove | Minnesota | 55369 | United States |
| M Health Fairview St. John's Hospital | Recruiting | Maplewood | Minnesota | 55109 | United States |
| M Health Fairview Clinics and Surgery Center | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| M Healt Fairview - Woodwinds Hospital | Recruiting | Woodbury | Minnesota | 55125 | United States |
| St. Dominic - Jackson Memorial Hospital | Recruiting | Jackson | Mississippi | 39216 | United States |
| St. Dominic Gynecologic Oncology | Recruiting | Jackson | Mississippi | 39216 | United States |
| Intermountain Health Saint Vincent Regional Hospital | Recruiting | Billings | Montana | 59101 | United States |
| Saint Vincent Regional Hospital- Cancer Centers of Montana | Recruiting | Billings | Montana | 59102 | United States |
| Yellowstone Eye Care | Recruiting | Billings | Montana | 59102 | United States |
| Intermountain Health West End Clinic- Gynecologic Oncology | Recruiting | Billings | Montana | 59106 | United States |
| Women's Cancer Center of Nevada | Recruiting | Las Vegas | Nevada | 89106 | United States |
| MD Anderson Cancer Center at Cooper | Recruiting | Camden | New Jersey | 08103 | United States |
| MD Anderson Cancer Center at Cooper | Recruiting | Voorhees Township | New Jersey | 08043 | United States |
| Maimonides Medical Center | Recruiting | Brooklyn | New York | 11220 | United States |
| Columbia University Medical Center - Herbert Irving Pavilion | Not yet recruiting | New York | New York | 10032 | United States |
| IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy | Not yet recruiting | New York | New York | 10032 | United States |
| Miami Valley Hospital South | Recruiting | Centerville | Ohio | 45459 | United States |
| Kettering Health Cancer Center | Recruiting | Kettering | Ohio | 45429 | United States |
| Kettering Health Main Campus | Recruiting | Kettering | Ohio | 45429 | United States |
| Oklahoma Cancer Specialists and Research Institute, LLC | Recruiting | Tulsa | Oklahoma | 74146 | United States |
| Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic | Recruiting | Providence | Rhode Island | 02905 | United States |
| Women & Infants Hospital of Rhode Island | Recruiting | Providence | Rhode Island | 02905 | United States |
| Texas Oncology - Central South | Recruiting | Austin | Texas | 78731 | United States |
| Texas Oncology - Central South | Recruiting | Austin | Texas | 78745 | United States |
| Texas Oncology - Central South | Recruiting | Austin | Texas | 78758 | United States |
| Texas Oncology - Central South | Recruiting | Harlingen | Texas | 78550 | United States |
| Texas Oncology - Central South | Recruiting | McAllen | Texas | 78503 | United States |
| Texas Oncology - Central South | Recruiting | Waco | Texas | 76712 | United States |
| Texas Oncology - Central South | Recruiting | Weslaco | Texas | 78596 | United States |
| University of Virginia Comprehensive Cancer Center | Recruiting | Charlottesville | Virginia | 22903 | United States |
| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
| UVA Health Cancer Care Pantops | Recruiting | Charlottesville | Virginia | 22911 | United States |
| Carilion Clinic Gynecologic Oncology | Recruiting | Roanoke | Virginia | 24016 | United States |
| Puerto Rico Cancer Specialists Clinical Trials | Recruiting | San Juan | 00917-5027 | Puerto Rico |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009369 | Neoplasms |
| D000091662 | Genital Diseases |
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