Clinical Trials /

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

NCT04697628

Description:

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.

Related Conditions:
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: SGNTV-003
  • NCT ID: NCT04697628

Conditions

  • Cervical Cancer

Interventions

DrugSynonymsArms
tisotumab vedotinTisotumab vedotin
topotecanChemotherapy
vinorelbineChemotherapy
gemcitabineChemotherapy
irinotecanChemotherapy
pemetrexedChemotherapy

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.

Trial Arms

NameTypeDescriptionInterventions
Tisotumab vedotinExperimentalTisotumab vedotin monotherapy
  • tisotumab vedotin
ChemotherapyActive ComparatorInvestigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
  • topotecan
  • vinorelbine
  • gemcitabine
  • irinotecan
  • pemetrexed

Eligibility 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, 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:OS is defined as the time from the date of randomization to the date of death due to any cause.

Secondary Outcome Measures

Measure:Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator
Time Frame:Up to approximately 1 year
Safety Issue:
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.
Measure:Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
Time Frame:Up to approximately 6 months
Safety Issue:
Description:Confirmed objective response rate is defined as the proportion of participants with a confirmed CR or partial response (PR) per RECIST v.1.1.
Measure:Time-to-response (TTR) as assessed by the investigator
Time Frame:Up to approximately 6 months
Safety Issue:
Description:TTR will be summarized descriptively by treatment group using the Kaplan-Meier approach. Only participants with confirmed complete response (CR) or partial response (PR) will be included in the analysis.
Measure:Duration of response (DOR) as assessed by the investigator
Time Frame:Up to approximately 1 year
Safety Issue:
Description:DOR will be summarized descriptively by treatment group using the Kaplan-Meier approach. Only participants with confirmed CR or PR will be included in the analysis.
Measure:Incidence of adverse events (AEs)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Analyses of AEs will be summarized descriptively
Measure:Health-related quality of life as assessed by EQ-5D-5L index
Time Frame:Up to approximately 2 years
Safety Issue:
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.
Measure:Health-related quality of life as assessed by EQ-5D visual analog scale (VAS)
Time Frame:Up to approximately 2 years
Safety Issue:
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.
Measure:Health-related quality of life as assessed by EORTC-QLQ-C30
Time Frame:Up to approximately 6 months
Safety Issue:
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.
Measure:Health-related quality of life as assessed by EORTC-QLQ-CX24
Time Frame:Up to approximately 6 months
Safety Issue:
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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seagen Inc.

Trial Keywords

  • Seattle Genetics

Last Updated

April 13, 2021