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

NCT03786081 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tisotumab Vedotin

Given into the vein (IV)

DRUG

Bevacizumab

Given via IV

DRUG

Pembrolizumab

Given via IV

DRUG

Carboplatin

Given via IV

Sponsors & Collaborators

  • Genmab

    collaborator INDUSTRY

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Belgian Gynaecological Oncology Group

    collaborator OTHER

  • GOG Foundation

    collaborator NETWORK

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Seagen, a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2026-03-19
Completion
2026-03-19
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • Denmark
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03786081 on ClinicalTrials.gov