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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Gynecological Cancer

Tisotumab vedotin

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

Phase 3

NCT04697628

Active Not-enrolling

Globe

Locations

United States, Argentina, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Peru, Poland, Singapore, Spain, Sweden, Taiwan, United Kingdom

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Study design
Participant Group/Arm

EXPERIMENTAL: Tisotumab vedotin

Tisotumab vedotin monotherapy

Intervention/Treatment

DRUG: tisotumab vedotin

2.0 mg/kg every 3 weeks (Q3W)

Participant Group/Arm

ACTIVE_COMPARATOR: Chemotherapy

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

Intervention/Treatment

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

Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria

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 age
  • 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. 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.
Exclusion criteria

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.
Key dates
Study start date
  • February 2021
Estimated Study Completion Date
  • February 2028
Key endpoints
Primary Outcome Measures
Outcome Measure

Overall survival (OS)

Measure Description

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time Frame

Up to approximately 2 years

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator

Measure Description

PFS per investigator is defined as the time from the date of randomization to the first documentation of disease progression per RECIST v.1.1 by the investigator, or to date of death due to any cause, whichever occurs earlier.

Time Frame

Up to approximately 1 year

Outcome Measure

Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator

Measure Description

Confirmed objective response rate is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.

Time Frame

Up to approximately 6 months

Outcome Measure

Time-to-response (TTR) as assessed by the investigator

Measure Description

TTR is defined as the time from the date of randomization to the date of first confirmed objective response (CR or PR that is subsequently confirmed). Only participants with confirmed CR or PR will be included in the analysis.

Time Frame

Up to approximately 6 months

Outcome Measure

Duration of response (DOR) as assessed by the investigator

Measure Description

DOR is defined as the time from the date of first confirmed objective response (CR or PR that is subsequently confirmed) to the date of first documented PD per RECIST v1.1 or death from any cause, whichever occurs first. Only participants with confirmed CR or PR will be included in the analysis.

Time Frame

Up to approximately 1 year

Outcome Measure

Incidence of adverse events (AEs)

Measure Description

Analyses of AEs will be summarized descriptively

Time Frame

Up to approximately 2 years

Outcome Measure

Health-related quality of life as assessed by EQ-5D-5L index

Measure Description

EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of HRQOL that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Time Frame

Up to approximately 2 years

Outcome Measure

Health-related quality of life as assessed by EQ-5D visual analog scale (VAS)

Measure Description

EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of HRQOL that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The EQ VAS records the participant's self-rated health on a vertical VAS. This can be used as a quantitative measure of health outcome that reflects the participant's own judgment.

Time Frame

Up to approximately 2 years

Outcome Measure

Health-related quality of life as assessed by EORTC-QLQ-C30

Measure Description

The QLQ-C30 is a validated questionnaire developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess the quality of life of participants with cancer in multicultural clinical research settings.

Time Frame

Up to approximately 6 months

Outcome Measure

Health-related quality of life as assessed by EORTC-QLQ-CX24

Measure Description

The EORTC-QLQ-CX24 is a validated questionnaire developed by the EORTC to assess the quality of life in patients who are treated for cervical cancer both in clinical studies and in clinical practice.

Time Frame

Up to approximately 6 months

Secondary Outcome Measures table for Clinical Trial
Number of participants

556

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: Genmab

This information is current as of August 9th 2024.

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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT04697628