Purpose

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of four different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and: - Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: - paclitaxel+cisplatin+bevacizumab, or - paclitaxel+carboplatin+bevacizumab, or - paclitaxel+topotecan/nogitecan+bevacizumab - Note: In cases where bevacizumab is not a standard of care therapy or the participant is ineligible for bevacizumab treatment according to local standards, prior treatment with bevacizumab is not required. - Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with pembrolizumab for r/mCC cancer should be counted. - Measurable disease according to RECIST v1.1 as assessed by the investigator. - Has ECOG performance status of 0 or 1 prior to randomization. - Has life expectancy of at least 3 months.

Exclusion Criteria

  • Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above. - Has clinically significant bleeding issues or risks. This includes known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry. - Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack >1 month prior to screening is allowed). - Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (e.g. Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants. Cataracts alone is not an exclusion criterion. - Major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration. - Peripheral neuropathy ≥grade 2. - Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tisotumab vedotin
Tisotumab vedotin monotherapy
  • Drug: tisotumab vedotin
    2.0 mg/kg every 3 weeks (Q3W)
Active Comparator
Chemotherapy
Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
  • Drug: topotecan
    1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
  • Drug: vinorelbine
    30 mg/m2 IV on Days 1 and 8, every 21 days
  • Drug: gemcitabine
    1000 mg/m2 IV on Days 1 and 8, every 21 days
  • Drug: irinotecan
    100 or 125 mg/m2 IV weekly for 28 days, every 42 days
  • Drug: pemetrexed
    500 mg/m2 IV on Day 1, every 21 days

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294-3300
Contact:
Anna Wilbanks
205-934-4011

More Details

Status
Recruiting
Sponsor
Seagen Inc.

Study Contact

Seagen Trial Information Support
8663337436
clinicaltrials@seagen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.