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NCT04697628

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Last Updated: 2025-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2026-05-07

Brief Summary

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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 five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, 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.

Detailed Description

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Conditions

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Cervical Cancer

Keywords

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Seattle Genetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tisotumab vedotin

Tisotumab vedotin monotherapy

Group Type EXPERIMENTAL

tisotumab vedotin

Intervention Type DRUG

2.0 mg/kg every 3 weeks (Q3W)

Chemotherapy

Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)

Group Type ACTIVE_COMPARATOR

topotecan

Intervention Type DRUG

1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days

vinorelbine

Intervention Type DRUG

30 mg/m2 IV on Days 1 and 8, every 21 days

gemcitabine

Intervention Type DRUG

1000 mg/m2 IV on Days 1 and 8, every 21 days

irinotecan

Intervention Type DRUG

100 or 125 mg/m2 IV weekly for 28 days, every 42 days

pemetrexed

Intervention Type DRUG

500 mg/m2 IV on Day 1, every 21 days

Interventions

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tisotumab vedotin

2.0 mg/kg every 3 weeks (Q3W)

Intervention Type DRUG

topotecan

1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days

Intervention Type DRUG

vinorelbine

30 mg/m2 IV on Days 1 and 8, every 21 days

Intervention Type DRUG

gemcitabine

1000 mg/m2 IV on Days 1 and 8, every 21 days

Intervention Type DRUG

irinotecan

100 or 125 mg/m2 IV weekly for 28 days, every 42 days

Intervention Type DRUG

pemetrexed

500 mg/m2 IV on Day 1, every 21 days

Intervention Type DRUG

Other Intervention Names

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TIVDAK PF-08046057

Eligibility Criteria

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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 + anti-PD-(L)1 agent, or
* paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or
* paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent
* Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent 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 an anti-PD(L)1 agent 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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Arizona Oncology Associates, PC - HAL

Glendale, Arizona, United States

Site Status

Arizona Oncology Associates P.C. - NAHOA

Phoenix, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Scottsdale, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, United States

Site Status

University of California Irvine Health

Irvine, California, United States

Site Status

UC Irvine Health (Investigator Site File Location)

Orange, California, United States

Site Status

University of California Irvine Health

Orange, California, United States

Site Status

Olive View - UCLA Medical Center

Sylmar, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Site Status

Northwestern Medical Group

Chicago, Illinois, United States

Site Status