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

Cervical Cancer Clinical Trial

— SKYSCRAPER-04  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04300647
• Other study ID #: WO42017
• Secondary ID: 2019-004895-21
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 30, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 172
• Est. completion date: May 1, 2024
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Mater Misericordiae Limited	South Brisbane	Queensland
Brazil	Hospital Araujo Jorge; Departamento de Ginecologia E Mama	Goiania	GO
Brazil	Hospital de Caridade de Ijui; Oncologia	Ijui	RS
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Hospital Sao Rafael - HSR	Salvador	BA
Brazil	Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda	Sao Paulo	SP
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Hamilton Health Sciences - Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre - Glen Site	Montreal	Quebec
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Costa Rica	Clinica CIMCA	San José
Costa Rica	ICIMED Instituto de Investigación en Ciencias Médicas	San José
Costa Rica	Oncotech S.A.	San José
France	Centre Leon Berard	Lyon
France	Institut Paoli Calmettes	Marseille
France	Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque	Montpellier
France	ICO - Site René Gauducheau	Saint Herblain
France	Gustave Roussy	Villejuif
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	IRCCS S. Raffaele; Ginecologia Oncologica	Milano	Lombardia
Italy	Istituto Europeo Di Oncologia	Milano	Lombardia
Italy	Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica	Napoli	Campania
Italy	Policlinico Universitario Agostino Gemelli	Roma	Lazio
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Mexico	Christus Muguerza Clinica Vidriera	Monterrey	Nuevo LEON
Panama	Centro Oncológico de Panamá	Panama
Panama	The Panama Clinic	Panama
Peru	Clinica Ricardo Palma	San Isidro
Poland	Bialostockie Centrum Onkologi	Bialystok
Poland	Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny	Gdynia
Poland	Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.	Gliwice
Poland	Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie	Poznan
Poland	Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej	Warszawa
Russian Federation	Chelyabisnk regional clinical center for oncology and nuclear medicine	Chelyabinsk	Sverdlovsk
Russian Federation	Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic	Kazan	Tatarstan
Russian Federation	FSBI "National Medical Research Center of Oncology N.N. Blokhin?	Moscow	Moskovskaja Oblast
Russian Federation	MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy	Moscow	Moskovskaja Oblast
Russian Federation	Murmansk Regional Clinical Hospital named after P.A. Bayandin	Murmansk
Russian Federation	Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological	Tomsk
Russian Federation	Volgograd Regional Clinical Oncology Dispensary	Volgograd
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia	A Coruña	LA Coruña
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Taiwan	Taichung Veterans General Hospital; Obstetrics and Gynecology	Taichung
Taiwan	Mackay Memorial Hospital; Obstetrics & Gynaecology	Taipei City
Taiwan	National Taiwan University Hospital; Obstetrics & Gynecology	Taipei City
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology	Taoyuan City
Thailand	Siriraj Hospital, Mahidol University	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University	Muang
United Kingdom	Sarah Cannon Research Institute	London
United Kingdom	University College London Hospital	London
United Kingdom	Christie Hospital Nhs Trust; Medical Oncology	Manchester
United States	Augusta University	Augusta	Georgia
United States	Oncology Associates of Oregon, P.C	Eugene	Oregon
United States	Kaiser Permanente - Irvine	Irvine	California
United States	Arizona Oncology Associates	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Costa Rica,  France,  Italy,  Korea, Republic of,  Mexico,  Panama,  Peru,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)		From randomization up to approximately 36 months
Secondary	Percentage of Participants With Adverse Events		Up to 36 months
Secondary	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 approximately 36 months)
Secondary	IRC-Assessed Disease Control Rate (DCR)		From randomization up to approximately 36 months
Secondary	Investigator-Assessed Best Clinical Response (BCR) Rate		From randomization up to approximately 36 months
Secondary	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 approximately 36 months)
Secondary	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 approximately 36 months)
Secondary	IRC-Assessed PFS Rate at 6 Months		At 6 months post-randomization
Secondary	Overall Survival (OS)		From randomization to death from any cause (up to 36 months)
Secondary	OS Rate at 6 Months and 12 Months		At 6 and 12 months post-randomization
Secondary	Minimum Serum Concentration (Cmin) of Tiragolumab		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)
Secondary	Maximum Serum Concentration (Cmax) of Tiragolumab		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)
Secondary	Cmin of Atezolizumab		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)
Secondary	Cmax of Atezolizumab		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)
Secondary	Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab		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)
Secondary	Percentage of Participants With ADAs to Atezolizumab		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)