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

February 12, 2024 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited
  • Brazil
    • BA
      • Salvador, BA, Brazil, 41253-190
        • Hospital Sao Rafael - HSR
    • GO
      • Goiania, GO, Brazil, 74605-070
        • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Hospital de Caridade de Ijui; Oncologia
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
    • SP
      • Sao Paulo, SP, Brazil, 01317-001
        • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Health Sciences - Juravinski Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre - Glen Site
  • Costa Rica
      • San José, Costa Rica, 10103
        • Clinica CIMCA
      • San José, Costa Rica, 10108
        • ICIMED Instituto de Investigación en Ciencias Médicas
      • San José, Costa Rica, 10103
        • Oncotech S.A.
  • France
      • Lyon, France, 69008
        • Centre Leon Berard
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Montpellier, France, 34298
        • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
      • Saint Herblain, France, 44805
        • ICO - Site René Gauducheau
      • Villejuif, France, 94805
        • Gustave Roussy
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milano, Lombardia, Italy, 20132
        • IRCCS S. Raffaele; Ginecologia Oncologica
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 01812
        • Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
  • Mexico
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64570
        • Christus Muguerza Clinica Vidriera
  • Panama
      • Panama, Panama, 0801
        • Centro Oncológico de Panamá
      • Panama, Panama, 0832-02723
        • The Panama Clinic
  • Peru
      • San Isidro, Peru, Lima 27
        • Clinica Ricardo Palma
  • Poland
      • Bialystok, Poland, 15-027
        • Bialostockie Centrum Onkologi
      • Gdynia, Poland, 81-519
        • Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny
      • Gliwice, Poland, 44-101
        • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
      • Poznan, Poland, 61-866
        • Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
      • Warszawa, Poland, 02-781
        • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
  • Russian Federation
      • Murmansk, Russian Federation, 183047
        • Murmansk Regional Clinical Hospital named after P.A. Bayandin
      • Tomsk, Russian Federation, 634028
        • Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological
      • Volgograd, Russian Federation, 400138
        • Volgograd regional clinical oncology dispensary
    • Moskovskaja Oblast
      • Moscow, Moskovskaja Oblast, Russian Federation, 143422
        • MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
      • Moscow, Moskovskaja Oblast, Russian Federation, 115478
        • FSBI "National Medical Research Center of Oncology N.N. Blokhin?
    • Sverdlovsk
      • Chelyabinsk, Sverdlovsk, Russian Federation, 454087
        • Chelyabisnk regional clinical center for oncology and nuclear medicine
    • Tatarstan
      • Kazan, Tatarstan, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Oncologia
    • LA Coruña
      • A Coruña, LA Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital; Obstetrics and Gynecology
      • Taipei City, Taiwan, 110
        • National Taiwan University Hospital; Obstetrics & Gynecology
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei City, Taiwan
        • Mackay Memorial Hospital; Obstetrics & Gynaecology
      • Taoyuan City, Taiwan, 333
        • Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital, Mahidol University
      • Muang, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University
  • United Kingdom
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute
      • London, United Kingdom, N7 9NH
        • University College London Hospital
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust; Medical Oncology
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates
    • California
      • Irvine, California, United States, 92618
        • Kaiser Permanente - Irvine
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon, P.C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Tecentriq
  • RO5541267
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:
  • Tecentriq
  • RO5541267

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
Time Frame: From randomization up to approximately 36 months
From randomization up to approximately 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events
Time Frame: Up to 36 months
Up to 36 months
IRC-Assessed Duration of Response (DOR)
Time Frame: First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
IRC-Assessed Disease Control Rate (DCR)
Time Frame: From randomization up to approximately 36 months
From randomization up to approximately 36 months
Investigator-Assessed Best Clinical Response (BCR) Rate
Time Frame: From randomization up to approximately 36 months
From randomization up to approximately 36 months
Investigator-Assessed DOR
Time Frame: First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
IRC-Assessed Progression-Free Survival (PFS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Overall Survival (OS)
Time Frame: From randomization to death from any cause (up to 36 months)
From randomization to death from any cause (up to 36 months)
IRC-Assessed PFS Rate at 6 Months
Time Frame: At 6 months post-randomization
At 6 months post-randomization
OS Rate at 6 Months and 12 Months
Time Frame: At 6 and 12 months post-randomization
At 6 and 12 months post-randomization
Minimum Serum Concentration (Cmin) of Tiragolumab
Time Frame: Predose and 30 minutes 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)
Predose and 30 minutes 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)
Maximum Serum Concentration (Cmax) of Tiragolumab
Time Frame: Predose and 30 minutes 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)
Predose and 30 minutes 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)
Cmin of Atezolizumab
Time Frame: Predose and 30 minutes 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)
Predose and 30 minutes 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)
Cmax of Atezolizumab
Time Frame: Predose and 30 minutes 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)
Predose and 30 minutes 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)
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time Frame: Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (each cycle is 21 days) and at TD visit (up to 36 months)
Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (each cycle is 21 days) and at TD visit (up to 36 months)
Percentage of Participants With ADAs to Atezolizumab
Time Frame: Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (each cycle is 21 days) and at TD visit (up to 36 months)
Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (each cycle is 21 days) and at TD visit (up to 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

December 8, 2021

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO42017
  • 2019-004895-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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