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

Sponsor
Seagen Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04697628
Collaborator
Genmab (Industry)
482
Enrollment
139
Locations
2
Arms
84.2
Anticipated Duration (Months)
3.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
482 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 22, 2021
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Feb 28, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tisotumab vedotin

Tisotumab vedotin monotherapy

Drug: tisotumab vedotin
2.0 mg/kg every 3 weeks (Q3W)
Other Names:
  • TIVDAK

    		•
    Active Comparator: Chemotherapy

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

    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

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [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.

    Secondary Outcome Measures

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

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

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

    4. Duration of response (DOR) as assessed by the investigator [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.

    5. Incidence of adverse events (AEs) [Up to approximately 2 years]

      Analyses of AEs will be summarized descriptively

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

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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294-3300
    2 Arizona Oncology Associates, PC - HAL Phoenix Arizona United States 85016
    3 Arizona Oncology Associates, PC - HOPE Tucson Arizona United States 85710
    4 University of California Irvine Medical Center Irvine California United States 92697
    5 Olive View - UCLA Medical Center Sylmar California United States 91342
    6 Yale Cancer Center New Haven Connecticut United States 06520
    7 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    8 Augusta University Augusta Georgia United States 30912
    9 Northwestern Memorial Hospital Chicago Illinois United States 60611
    10 Gynecological Cancer Institute of Chicago, LLC Oak Lawn Illinois United States 60453
    11 Norton Cancer Institute Louisville Kentucky United States 40207
    12 Willis-Knighton Physician Network/Gynecologic Oncology Associates Shreveport Louisiana United States 71103
    13 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    14 Minnesota Oncology Hematology P.A. Minneapolis Minnesota United States 55404
    15 St. Dominic - Jackson Memorial Hospital Jackson Mississippi United States 39216
    16 Washington University in St Louis Saint Louis Missouri United States 63108
    17 Holy Name Medical Center Teaneck New Jersey United States 07666
    18 Weill Cornell Medicine Brooklyn New York United States 11215
    19 Weill Cornell Medicine Flushing New York United States 11355
    20 New York University (NYU) Cancer Institute New York New York United States 10016
    21 UNC Lineberger Comprehensive Cancer Center / University of North Carolina Chapel Hill North Carolina United States 27599
    22 Cleveland Clinic Fairview Hospital Cleveland Ohio United States 44111
    23 Cleveland Clinic, The Cleveland Ohio United States 44195
    24 Ohio State University Clinical Trials Management Office Hilliard Ohio United States 43026
    25 Kettering Health Kettering Ohio United States 45429
    26 Cleveland Clinic Hillcrest Hospital Mayfield Heights Ohio United States 44124
    27 Oncology Associates of Oregon Eugene Oregon United States 97401
    28 Northwest Cancer Specialists, P.C. Portland Oregon United States 97227
    29 Texas Oncology - Austin Central Austin Texas United States 78731
    30 Texas Oncology - Fort Worth 12th Avenue Fort Worth Texas United States 76104
    31 Texas Oncology - The Woodlands The Woodlands Texas United States 77380
    32 Texas Oncology - Tyler Tyler Texas United States 75702
    33 University of Virginia Charlottesville Virginia United States 22901
    34 Virginia Oncology Associates Norfolk Virginia United States 23502
    35 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298
    36 Carbone Cancer Center / University of Wisconsin Madison Wisconsin United States 53792
    37 Fundacion Cenit Caba Argentina 1125
    38 Sanatorio de la Mujer Rosario Argentina 2000
    39 Institut Jules Bordet Anderlecht Other Belgium B-1070
    40 ZNA Middelheim Antwerpen Other Belgium 2020
    41 Cliniques Universitaires Saint Luc Brussels Other Belgium 1200
    42 Grand Hopital de Charleroi Charleroi Other Belgium 6000
    43 Universitair Ziekenhuis Gent Gent Other Belgium 9000
    44 UZ Leuven campus Gasthuisberg Leuven Other Belgium 3000
    45 CHU de Liege Liege Other Belgium 4000
    46 CHU UCL Namur-Site de Saint Elisabeth Namur Other Belgium 5000
    47 Centro de PesquisaemOncologia - HSL-PUCRS Porto Alegre, Rio Grande Do Sul Other Brazil 90610-000
    48 Erasto Gaertner Hospital CuriBba Brazil 81520-060
    49 Instituto Brasileiro de Controle do Cancer Formosa Brazil 73801-340
    50 Hospital de Caridade de Ijuí Ijuí Brazil
    51 Hospital Mãe de Deus Porto Alegre Brazil
    52 University of Alberta / Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    53 British Columbia Cancer Agency - Vancouver Centre Vancouver British Columbia Canada V5Z 4E6
    54 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    55 University Health Network, Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    56 Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika Olomouc Other Czechia 779 00
    57 Charles University General Hospital Praha 2 Other Czechia 128 08
    58 Hospital Na Bulovce Praha 8-Liben Other Czechia 18081
    59 Kuopio University Hospital Kuopio Other Finland 70210
    60 Tampere University Hospital Tampere, Pirkanmaa Other Finland 33520
    61 University of Turku Turku Other Finland 20520
    62 Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz Besancon Cedex Other France 25000
    63 CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie Cotes d'Armor Other France 22190
    64 Institute Cancer De Lorraine (ICL) - Alexis Vautrin Moselle Other France 54519
    65 Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Avron (Hopital de la Croix Saint-Simon) Paris Other France 75020
    66 Institut de cancerologie Strasbourg Europe Strasbourg Other France 67200
    67 Institut Gustave Roussy Villejuif Cedex Other France 94805
    68 National Institute of Oncology Hungary Budapest, Pest Other Hungary 1122
    69 Medical and Health Science Centre Debrecen Institution of Internal Medicine Debrecen, Hajdú-Bihar Other Hungary 4032
    70 Bacs-Kiskun Megyei Oktatokorhaz Kecskemet Other Hungary H6000
    71 IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l Meldola Other Italy 47014
    72 Ospedale San Raffaele Milano Other Italy 20132
    73 Fondazione Policlinico Universitario Agostino Rome Other Italy 00168
    74 Hospital San Bortolo Vicenza Other Italy 37-36100
    75 National Cancer Center Hospital Chuo-ku Other Japan 104-0045
    76 Gunma University Hospital Gunma Other Japan 371-8511
    77 Saitama Cancer Center Hidaka-City Other Japan
    78 Kagoshima University Hospital Kagoshima City Other Japan 890-8520
    79 Kagoshima City Hospital Kagoshima-City Other Japan 890-8760
    80 National Cancer Center Hospital East Kashiwa-shi Other Japan 277-8577
    81 The Jikei University Kashiwa Hospital Kashiwashi Other Japan 277-8567
    82 Shikoku Cancer Center Matsuyama Other Japan 791-0280
    83 Aichi Cancer Center Nagoya-shi Other Japan 464-8681
    84 University of the Ryukyus Hospital Nakagami-gun Other Japan 903-0215
    85 Okayama University Hospital Okayama Other Japan 700-8558
    86 Kindai University Hospital Osakasayama Other Japan 589-8511
    87 Osaka International Cancer Institute Osaka Other Japan 541-8567
    88 National Hospital Organization Hokkaido Cancer Center Sapporo-shi Other Japan 003-0804
    89 Hokkaido University Hospital Sapporo-shi Other Japan
    90 Iwate Medical University Hospital Shiwa-gun Other Japan
    91 Shizuoka Cancer Center Sunto-Gun Other Japan 411-8777
    92 The Cancer Institute Hospital of JFCR Tokyo Other Japan 135-8550
    93 Keio University Hospital Tokyo Other Japan 160-8582
    94 Kanagawa Cancer Center Yokohama Other Japan 241-8515
    95 Hyogo Cancer Center Akashi Japan 673-8558
    96 Ehime University Hospital Ehime Japan
    97 Kurume University Hospital Fukuoka Japan 830-0011
    98 National Hospital Organization Kure Medical Center and Chugoku Cancer Center Hiroshima Japan 737-0023
    99 Nippon Medical School Musashi Kosugi Hospital Kanagawa Japan 211-8533
    100 Niigata Cancer Center Hospital Niigata Japan 951-8133
    101 Jikei University Hospital Tokyo Japan 105-0003
    102 Yokohama City University Hospital Yokohama Japan 232-0024
    103 Keimyung University Dongsan Medical Center Daegu Other Korea, Republic of 42601
    104 National Cancer Center Goyang-si Other Korea, Republic of 10408
    105 Seoul National University Bundang Hospital Seongnam-si Other Korea, Republic of 13605
    106 CHA Bundang Medical Center Seongnam Other Korea, Republic of 13496
    107 Korea Cancer Center Hospital Seoul Other Korea, Republic of 01802
    108 Seoul National University Hospital Seoul Other Korea, Republic of 03080
    109 Soon Chun Hyang University Hospital Seoul Seoul Other Korea, Republic of 04401
    110 Asan Medical Center Seoul Other Korea, Republic of 05505
    111 Samsung Medical Center Seoul Other Korea, Republic of 06351
    112 Ewha Womans University Mokdong Hospital Seoul Other Korea, Republic of 07985
    113 Severance Hospital, Yonsei University Health System Seoul Other Korea, Republic of 120-752
    114 Sungkyunkwan University of Medicine - Samsung Changwon Hospital Changwon, Kyungsangnam-do Korea, Republic of 51353
    115 Oncologico Potosino San Luis Potosí Mexico 78209
    116 Amsterdam UMC, Locatie AMC Amsterdam Other Netherlands 1105 AZ
    117 Maastricht University Medical Center Maastricht Other Netherlands 6229 HX
    118 Erasmus Medisch Centrum Rotterdam Other Netherlands 3015GD
    119 Universitair Medisch Centrum Utrecht Utrecht Other Netherlands 3584 CX
    120 Trondheim University Hospital, Trondheim Trondheim Other Norway 7030
    121 National University Cancer Institute, Singapore Singapore Other Singapore 119228
    122 National Cancer Centre Singapore Singapore Other Singapore 169610
    123 Hospital Universitario Vall d'Hebron Barcelona Other Spain 08035
    124 Hospital Clinic de Barcelona Barcelona Other Spain 08036
    125 Hospital Universitario Reina Sofia Cordoba Other Spain 14004
    126 Clinica Universidad de Navarra Madrid Other Spain 28027
    127 Hospital Universitario 12 de Octubre Madrid Other Spain 28041
    128 Hospital Universitario La Paz Madrid Other Spain 28046
    129 Clinica Universidad de Navarra Pamplona Other Spain 31008
    130 Hospital Clinico Universitario de Valencia Valencia Other Spain 46010
    131 Skanes University Hospital - Universitetssjukhus Lund Other Sweden 22185
    132 Uppsala University Hospital (Akademiska Sjukhuset) Uppsala Other Sweden 75185
    133 Mackay Memorial Hospital Taipei City Other Taiwan 10449
    134 Taipei Veterans General Hospital Taipei City Other Taiwan 11217
    135 Chang Gung Memorial Hospital - Linkou Taoyuan Other Taiwan 333
    136 The Beatson West of Scotland Cancer Centre Glasgow Other United Kingdom G12 0YN
    137 The Royal Marsden Hospital London Other United Kingdom SW3 6JJ
    138 The Christie NHS Foundation Trust Manchester Other United Kingdom M20 4BX
    139 The Royal Marsden Hospital (Surrey) Sutton Other United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Seagen Inc.
    • Genmab

    Investigators

    • Study Director: Leo Nicacio, MD, Seagen Inc.
    • Study Director: Liz Whalley, PhD, Seagen Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT04697628
    Other Study ID Numbers:
    • SGNTV-003
    • ENGOT cx-12
    • GOG-3057
    First Posted:
    Jan 6, 2021
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seagen Inc.
    Seattle Genetics
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Gemcitabine
    Irinotecan
    Pemetrexed
    Topotecan
    Vinorelbine
    Tisotumab vedotin

    Study Results

    No Results Posted as of Aug 17, 2022