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SKYSCRAPER-04: A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04300647
Collaborator
(none)
172
Enrollment
66
Locations
2
Arms
36.5
Anticipated Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Actual Study Start Date :
Jun 30, 2020
Actual Primary Completion Date :
Dec 8, 2021
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tiragolumab plus Atezolizumab

Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Drug: Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Other Names:
  • RO7092284

    • Drug: Atezolizumab
    Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
    Other Names:
  • RO5541267
  • Tecentriq

    		•
    Experimental: Atezolizumab

    Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

    Drug: Atezolizumab
    Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
    Other Names:
  • RO5541267
  • Tecentriq

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) [From randomization up to 36 months]

    Secondary Outcome Measures

    1. Percentage of Participants With Adverse Events [Up to 36 months]

    2. IRC-Assessed Duration of Response (DOR) [First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months)]

    3. IRC-Assessed Disease Control Rate (DCR) [From randomization up to 36 months]

    4. Investigator-Assessed Best Clinical Response (BCR) Rate [From randomization up to 36 months]

    5. Investigator-Assessed DOR [First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months)]

    6. IRC-Assessed Progression-Free Survival (PFS) [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 36 months)]

    7. IRC-Assessed PFS Rate at 6 Months [6 months]

    8. Overall Survival (OS) [From randomization to death from any cause (up to 36 months)]

    9. OS Rate at 6 Months and 12 Months [6 months, 12 months]

    10. Minimum Serum Concentration (Cmin) of Tiragolumab [Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to 36 months)]

    11. Maximum Serum Concentration (Cmax) of Tiragolumab [Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)]

    12. Cmin of Atezolizumab [Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)]

    13. Cmax of Atezolizumab [Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)]

    14. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)]

    15. Percentage of Participants With ADAs to Atezolizumab [Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)]

    Eligibility Criteria

    Criteria

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

    • Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy

    • Radiologically-measurable disease

    • Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1

    • Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)

    • Life expectancy of at least 12 weeks

    • Adequate hematologic and organ function

    • Female of childbearing potential must be willing to comply with adequate contraception

    Exclusion Criteria:

    • Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization

    • Active or untreated central nervous system (CNS) or brain metastases

    • Active or history of autoimmune disease or immune deficiency

    • Active tuberculosis

    • Known, clinically significant liver disease

    • Severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety

    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies

    • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization

    • Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study

    • Pregnant or breastfeeding woman

    • Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates Phoenix Arizona United States 85016
    2 Kaiser Permanente - Irvine Irvine California United States 92618
    3 Augusta University Augusta Georgia United States 30912
    4 Oncology Associates of Oregon, P.C Eugene Oregon United States 97401
    5 Mater Misericordiae Limited South Brisbane Queensland Australia 4101
    6 Hospital Sao Rafael - HSR Salvador BA Brazil 41253-190
    7 Hospital Araujo Jorge; Departamento de Ginecologia E Mama Goiania GO Brazil 74605-070
    8 Hospital de Caridade de Ijui; Oncologia Ijui RS Brazil 98700-000
    9 Hospital Sao Lucas - PUCRS Porto Alegre RS Brazil 90610-000
    10 Hospital Nossa Senhora da Conceicao Porto Alegre RS Brazil 91350-200
    11 Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda Sao Paulo SP Brazil 01317-001
    12 Royal Victoria Regional Health Centre Barrie Ontario Canada L4M 6M2
    13 Hamilton Health Sciences - Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
    14 London Regional Cancer Centre London Ontario Canada N6A 4L6
    15 Princess Margaret Cancer Center Toronto Ontario Canada M5G 1Z5
    16 Jewish General Hospital Montreal Quebec Canada H3T 1E2
    17 McGill University Health Centre - Glen Site Montreal Quebec Canada H4A 3J1
    18 Clinica CIMCA San José Costa Rica 10103
    19 Oncotech S.A. San José Costa Rica 10103
    20 ICIMED Instituto de Investigación en Ciencias Médicas San José Costa Rica 10108
    21 Centre Leon Berard Lyon France 69008
    22 Institut Paoli Calmettes Marseille France 13009
    23 Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque Montpellier France 34298
    24 ICO - Site René Gauducheau Saint Herblain France 44805
    25 Gustave Roussy Villejuif CEDEX France 94800
    26 Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica Napoli Campania Italy 80131
    27 IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna Italy 47014
    28 Policlinico Universitario Agostino Gemelli Roma Lazio Italy 00168
    29 IRCCS S. Raffaele; Ginecologia Oncologica Milano Lombardia Italy 20132
    30 Istituto Europeo Di Oncologia Milano Lombardia Italy 20141
    31 Keimyung University Dongsan Hospital Daegu Korea, Republic of 41931
    32 Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences Seoul Korea, Republic of 01812
    33 Seoul National University Hospital Seoul Korea, Republic of 03080
    34 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    35 Asan Medical Center Seoul Korea, Republic of 05505
    36 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    37 Samsung Medical Center Seoul Korea, Republic of 06351
    38 Christus Muguerza Clinica Vidriera Monterrey Nuevo LEON Mexico 64570
    39 Centro Oncológico de Panamá Panama Panama 0801
    40 Centro Hemato Oncologico Panama Panama Panama 0832
    41 Clinica Ricardo Palma San Isidro Peru Lima 27
    42 Bialostockie Centrum Onkologi Bialystok Poland 15-027
    43 Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny Gdynia Poland 81-519
    44 Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter. Gliwice Poland 44-101
    45 Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie Poznan Poland 61-866
    46 Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej Warszawa Poland 02-781
    47 MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy Moscow Moskovskaja Oblast Russian Federation 143422
    48 Chelyabisnk regional clinical center for oncology and nuclear medicine Chelyabinsk Sverdlovsk Russian Federation 454087
    49 Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic Kazan Tatarstan Russian Federation 420029
    50 FSBI "National Medical Research Center of Oncology N.N. Blokhin" Moscow Russian Federation 115478
    51 Murmansk Regional Clinical Hospital named after P.A. Bayandin Murmansk Russian Federation 183047
    52 Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological Tomsk Russian Federation 634028
    53 Volgograd Regional Clinical Oncology Dispensary Volgograd Russian Federation 400138
    54 Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia A Coruña LA Coruña Spain 15006
    55 Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid Spain 28041
    56 Hospital Universitario La Paz; Servicio de Oncologia Madrid Spain 28046
    57 Taichung Veterans General Hospital; Obstetrics and Gynecology Taichung Taiwan 40705
    58 National Taiwan University Hospital; Obstetrics & Gynecology Taipei City Taiwan 110
    59 Taipei Veterans General Hospital Taipei City Taiwan 11217
    60 Mackay Memorial Hospital; Obstetrics & Gynaecology Taipei City Taiwan
    61 Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology Taoyuan City Taiwan 333
    62 Siriraj Hospital, Mahidol University Bangkok Thailand 10700
    63 Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University Muang Thailand 50200
    64 University College London Hospital London United Kingdom NW1 - 2PG
    65 Sarah Cannon Research Institute London United Kingdom W1G 6AD
    66 Christie Hospital Nhs Trust; Medical Oncology Manchester United Kingdom M2O 4BX

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04300647
    Other Study ID Numbers:
    • WO42017
    • 2019-004895-21
    First Posted:
    Mar 9, 2020
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Atezolizumab

    Study Results

    No Results Posted as of Aug 4, 2022