NCT04697628|CompletedPhase 3ResultsDMCFDA Drug

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

innovaTV 301

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

Seagen, a wholly owned subsidiary of Pfizer ClinicalTrials.gov

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3 other identifiers

SGNTV-003C57210022023-503813-31-01

Study Type

interventional

Target

502

Locations

25 countries

Sites

211

Timeline

RegisteredJan 2021

StartedFeb 2021

CompletionJan 2026

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

502

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Feb 2021

Longer than P75 for phase_3

Geographic Reach

25 countries

211 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

First Submitted

Initial submission to the registry

January 4, 2021

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed

2 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2023

Completed

1 year until next milestone

Results Posted

Study results publicly available

August 9, 2024

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

January 4, 2021

Results QC Date

July 16, 2024

Last Update Submit

February 5, 2026

Conditions

Cervical Cancer

Keywords

Seattle Genetics

Outcome Measures

Primary Outcomes (1)

Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)

Secondary Outcomes (9)

Progression Free Survival (PFS) as Assessed by Investigator
From the date of randomization to first documentation of PD or death due to any cause, or censoring date whichever occurred first (maximum up to 25 months)
Confirmed Objective Response Rate (ORR) as Assessed by Investigator
From the date of randomization until date of confirmed CR or PR (maximum up to 25 months)
Time-to-Response (TTR) as Assessed by the Investigator
From the date of randomization to date of date of the first confirmed objective response (maximum up to 25 months)
Duration of Response (DOR) by Investigator Assessment
From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 25 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
From start of treatment up to 30 days after last dose of study treatment (up to 25 months)
+4 more secondary outcomes

Study Arms (2)

Tisotumab vedotin

EXPERIMENTAL

Tisotumab vedotin monotherapy

Drug: tisotumab vedotin

Chemotherapy

ACTIVE COMPARATOR

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

Drug: topotecanDrug: vinorelbineDrug: gemcitabineDrug: irinotecanDrug: pemetrexed

Interventions

tisotumab vedotinDRUG

2.0 mg/kg every 3 weeks (Q3W)

Also known as: TIVDAK, PF-08046057

Tisotumab vedotin

topotecanDRUG

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

Chemotherapy

vinorelbineDRUG

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

Chemotherapy

gemcitabineDRUG

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

Chemotherapy

irinotecanDRUG

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

Chemotherapy

pemetrexedDRUG

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

Chemotherapy

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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).
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Seagen, a wholly owned subsidiary of Pfizerlead
Genmabcollaborator

Study Sites (211)

Arizona Oncology Associates, PC - HAL

Glendale, Arizona, 85308, United States

Location

Arizona Oncology Associates P.C. - NAHOA

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates, PC - HAL

Scottsdale, Arizona, 85258, United States

Location

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, 85284, United States

Location

University of California Irvine Health

Irvine, California, 92697, United States

Location

UC Irvine Health (Investigator Site File Location)

Orange, California, 92868, United States

Location

University of California Irvine Health

Orange, California, 92868, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

Location

Northwestern Medical Group

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Norton Cancer Institute, Downtown

Louisville, Kentucky, 40202, United States

Location

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD

Louisville, Kentucky, 40207, United States

Location

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, 40207, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Norton Women's & Children's Hospital

Louisville, Kentucky, 40207, United States

Location

Willis-Knighton Cancer Center Infusion Center

Shreveport, Louisiana, 71103, United States

Location

Willis-Knighton Physician Network/ Hematology-Oncology Associates

Shreveport, Louisiana, 71103, United States

Location

Willis-Knighton Physician Network/WK Gynecologic Oncology Associates

Shreveport, Louisiana, 71103, United States

Location

Willis-Knighton Physician Network/WK Gynecologic Oncology Associates

Shreveport, Louisiana, 71118, United States

Location

Minnesota Oncology Hematology PA

Coon Rapids, Minnesota, 55433, United States

Location