NCT03786081

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

A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The dose escalation part will occur in participants with cervical cancer who have progressed during or after standard of care therapy and who are intolerant or ineligible to receive standard of care treatments. Arm A will be conducted by escalating doses of both tisotumab vedotin and bevacizumab. Dose escalations of the tisotumab vedotin + pembrolizumab and tisotumab vedotin + carboplatin combinations (Arms B and C, respectively) will be conducted by combining fixed doses of either pembrolizumab or carboplatin with increasing doses of tisotumab vedotin. The dose expansion part of this study (Arms D through H) will be conducted in 2 populations: participants with cervical cancer who have not received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H) and participants with cervical cancer who have progressed on or after at least 1 but no more than 2 prior systemic therapies (Arms F and G). Participants enrolled to Arms D, E, F and H will receive the RP2D of tisotumab vedotin established in the dose escalation part. Participants enrolled to Arm G will receive tisotumab vedotin weekly (at a dose lower than subjects in all other Arms) for three weeks and 1 week off (28-day treatment cycle).

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Tisotumab Vedotin	Given into the vein (IV)
DRUG	Bevacizumab	Given via IV
DRUG	Pembrolizumab	Given via IV
DRUG	Carboplatin	Given via IV

Timeline

• Start date: 2019-02-27
• Primary completion: 2026-03-19
• Completion: 2026-03-19
• First posted: 2018-12-24
• Last updated: 2026-04-14

Locations

71 sites across 10 countries: United States, Belgium, Czechia, Denmark, Ireland, Italy, Netherlands, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study