Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Cervical Cancer

In brief

This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.

Key facts

Study ID

NCT03786081

Run by

Seagen, a wholly owned subsidiary of Pfizer

People needed

214

Starts

2019-02-27

Expected to finish

2026-03-19

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 squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after standard of care treatments or are ineligible or intolerant to standard of care for recurrent or stage IVB cervical cancer (Arms A, B and C only).
• Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H only).
• Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than two prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and G only).
• Must have baseline measurable disease per RECIST v1.1.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms).
• Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration
• Participants of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration.
• Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms).

You may not qualify if…

• Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms)
• Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms)
• Has clinically significant bleeding issues or risks
• Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arm A and bevacizumab-eligible participants in Arm H)
• Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arms A and H only)
• Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arms A and H only)
• Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms).
• Clinically significant cardiac disease
• Requires anti-coagulation therapy (Arms A and H only)

Where it is running

• Univ California, Irvine Medical Center — Orange, California, United States
• Olive View - UCLA Research and Education Institute — Sylmar, California, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Augusta University — Augusta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Oschner Clinic — New Orleans, Louisiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Billings Clinic Cancer Center — Billings, Montana, United States
• Montana Cancer Consortium — Billings, Montana, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
• University of Cincinnati Physicians Group — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University Wexner Medical Center — Hilliard, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Brown University - Women's and Infant Hospital — Providence, Rhode Island, United States
• St Francis Hospital Cancer Center — Greenville, South Carolina, United States
• Huntsman Cancer Center — Salt Lake City, Utah, United States
• Carilion Clinic — Roanoke, Virginia, United States
• Arizona Oncology Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.