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Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (innovaTV 301)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697628
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : September 21, 2022
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
Seagen Inc.

Tracking Information
First Submitted Date  ICMJE January 4, 2021
First Posted Date  ICMJE January 6, 2021
Last Update Posted Date September 21, 2022
Actual Study Start Date  ICMJE February 22, 2021
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
Overall survival (OS) [ Time Frame: Up to approximately 2 years ]
OS is defined as the time from the date of randomization to the date of death due to any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2022)
  • 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 ]
    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.
  • Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator [ Time Frame: Up to approximately 6 months ]
    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-to-response (TTR) as assessed by the investigator [ Time Frame: Up to approximately 6 months ]
    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.
  • Duration of response (DOR) as assessed by the investigator [ Time Frame: Up to approximately 1 year ]
    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.
  • Incidence of adverse events (AEs) [ Time Frame: Up to approximately 2 years ]
    Analyses of AEs will be summarized descriptively
  • Health-related quality of life as assessed by EQ-5D-5L index [ Time Frame: Up to approximately 2 years ]
    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.
  • Health-related quality of life as assessed by EQ-5D visual analog scale (VAS) [ Time Frame: Up to approximately 2 years ]
    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.
  • Health-related quality of life as assessed by EORTC-QLQ-C30 [ Time Frame: Up to approximately 6 months ]
    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.
  • Health-related quality of life as assessed by EORTC-QLQ-CX24 [ Time Frame: Up to approximately 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
  • 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 ]
    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.
  • Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator [ Time Frame: Up to approximately 6 months ]
    Confirmed objective response rate is defined as the proportion of participants with a confirmed CR or partial response (PR) per RECIST v.1.1.
  • Time-to-response (TTR) as assessed by the investigator [ Time Frame: Up to approximately 6 months ]
    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.
  • Duration of response (DOR) as assessed by the investigator [ Time Frame: Up to approximately 1 year ]
    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.
  • Incidence of adverse events (AEs) [ Time Frame: Up to approximately 2 years ]
    Analyses of AEs will be summarized descriptively
  • Health-related quality of life as assessed by EQ-5D-5L index [ Time Frame: Up to approximately 2 years ]
    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.
  • Health-related quality of life as assessed by EQ-5D visual analog scale (VAS) [ Time Frame: Up to approximately 2 years ]
    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.
  • Health-related quality of life as assessed by EORTC-QLQ-C30 [ Time Frame: Up to approximately 6 months ]
    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.
  • Health-related quality of life as assessed by EORTC-QLQ-CX24 [ Time Frame: Up to approximately 6 months ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: tisotumab vedotin
    2.0 mg/kg every 3 weeks (Q3W)
    Other Name: TIVDAK
  • 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 Arms  ICMJE
  • Experimental: Tisotumab vedotin
    Tisotumab vedotin monotherapy
    Intervention: Drug: tisotumab vedotin
  • Active Comparator: Chemotherapy
    Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
    Interventions:
    • Drug: topotecan
    • Drug: vinorelbine
    • Drug: gemcitabine
    • Drug: irinotecan
    • Drug: pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2021)
482
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2028
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seagen Trial Information Support 8663337436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Canada,   Czechia,   Finland,   France,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04697628
Other Study ID Numbers  ICMJE SGNTV-003
ENGOT cx-12 ( Other Identifier: European Network of Gynaecological Oncological Trial )
GOG-3057 ( Other Identifier: GOG Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Seagen Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Seagen Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Genmab
Investigators  ICMJE
Study Director: Leo Nicacio, MD Seagen Inc.
Study Director: Liz Whalley, PhD Seagen Inc.
PRS Account Seagen Inc.
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP