A randomized, Open-label, Phase 3 Trial of Tisotumab Vedotin vs Investigator’s choice chemotherapy in second or third-line recurrent of metastatic cervical cancer. (GOG-3057)

Purpose

Demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in participants with second or third-line cervical cancer

Criteria

1.      Have recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology.

2.      Have experienced disease progression during or after standard of care systemic chemotherapy.

3.      Have received one or two prior systemic therapy regimens for recurrent and/or metastatic cervical cancer.

You Cannot:

1.      Have primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not listed above.

2.      Have clinically significant bleeding history or risk factors.

3.      Major surgery within four weeks of enrollment.

Details

1.       Patient will be treated with either study drug or standard of care chemotherapy every 21 days.

2.       Patient will receive imaging every 6 weeks for the first 30 weeks.

3.       Lab collected at standard of care visits.

4.       Study stipend.



Interested in more information on clinical research? Contact WK Health System Clinical Research Department 318-212-8130 or ckay@wkhs.com

Interested in more information? Contact Us:

Destin Black, M.D., Principal Investigator
Gynecologic Oncology Associates
(318) 212-8727

IRB: Western
IRB Number:
Trial Type: NA
Sponsor: Seagen