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

NCT04300647 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: WO420172019-004895-21
• Study Type: interventional
• Target: 172
• Locations: 17 countries
• Sites: 58

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).

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)

  ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 millimeters (mm). PR=At least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. The study enrolled participants with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR. Percentages have been rounded off.

  From randomization up to approximately 17 months

Secondary Outcomes (15)

• Pre- and Post-crossover Periods: Number of Participants With Adverse Events (AEs)

  Up to approximately 50.3 months

• Pre-crossover Period: IRC-assessed Duration of Response (DOR)

  First occurrence of a documented objective response to the date of PD or death from any cause, whichever occurred first (up to approximately 17 months)

• Pre-crossover Period: IRC-assessed Disease Control Rate (DCR)

  From randomization up to approximately 17 months

• Pre-crossover Period: Investigator-assessed Best Clinical Response (BCR) Rate

  From randomization up to approximately 17 months

• Pre-crossover Period: Investigator-assessed Duration of BCR

  First occurrence of a documented clinical response to the date of PD or death from any cause, whichever occurred first (up to approximately 17 months)

Study Arms (2)

Tiragolumab plus Atezolizumab

EXPERIMENTAL

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

Drug: Tiragolumab; Drug: Atezolizumab

Atezolizumab

EXPERIMENTAL

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

Drug: Atezolizumab

Interventions

Tiragolumab DRUG

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.

Also known as: RO7092284

Tiragolumab plus Atezolizumab

Atezolizumab DRUG

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

Also known as: RO5541267, Tecentriq

Atezolizumab; Tiragolumab plus Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (58)

Arizona Oncology Associates

Phoenix, Arizona, 85016, United States

Location

Kaiser Permanente - Irvine

Irvine, California, 92616, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Oncology Associates of Oregon, P.C

Eugene, Oregon, 97401, United States

Location

Mater Misericordiae Limited

South Brisbane, Queensland, 4101, Australia

Location

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Hospital Araujo Jorge

Goiânia, Goiás, 74605-070, Brazil

Location

Hospital de Caridade de Ijui

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, 01317-000, Brazil

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 1Z5, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre - Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Clinica CIMCA

San José, 10103, Costa Rica

Location

ICIMED Instituto de Investigación en Ciencias Médicas

San José, 10108, Costa Rica

Location

Centre Leon Berard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

Montpellier, 34298, France

Location

ICO - Site René Gauducheau

Saint-Herblain, 44805, France

Location

Gustave Roussy

Villejuif, 94800, France

Location

Istituto Tumori Napoli

Naples, Campania, 80131, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

Istituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

Location

Christus Muguerza Clinica Vidriera

Monterrey, Nuevo León, 64570, Mexico

Location

Centro Oncológico de Panamá

Panama City, 0801, Panama

Location

The Panama Clinic

Panama City, 0832, Panama

Location

Clinica Ricardo Palma

San Isidro, Lima 27, Peru

Location

Bialostockie Centrum Onkologi

Bialystok, 15-027, Poland

Location

Szpital Morski im.PCK

Gdynia, 81-519, Poland

Location

Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice

Gliwice, 44-101, Poland

Location

Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

Poznan, 61-866, Poland

Location

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

MEDSI Clinical Hospital on Pyatnitsky Highway

Moscow, Moscow Oblast, 143422, Russia

Location

Chelyabisnk regional clinical center for oncology and nuclear medicine

Chelyabinsk, Sverdlovsk Oblast, 454087, Russia

Location

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

Kazan', Tatarstan Republic, 420029, Russia

Location

Tomsk scientific research institute of oncology SO RAMN, PAD

Tomsk, 634050, Russia

Location

Volgograd Regional Clinical Oncology Dispensary

Volgograd, 400138, Russia

Location

Keimyung University Dongsan Hospital

Daegu, 41931, South Korea

Location

Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences

Seoul, 01812, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, 15006, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

Chang Gung Medical Foundation, Linkou Branch

Taoyuan, 333, Taiwan

Location

Maharaj Nakorn Chiang Mai Hospital

Muang, 50200, Thailand

Location

University College London Hospital

London, NW1 - 2PG, United Kingdom

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

Related Publications (1)

• Salani R, McCormack M, Kim YM, Ghamande S, Hall SL, Lorusso D, Barraclough L, Gilbert L, Guzman Ramirez A, Lu CH, Sabatier R, Colombo N, Hu Y, Krishnan V, Molinero L, Feng Y, Kim N, Castro M, Lin YG, Monk BJ. A non-comparative, randomized, phase II trial of atezolizumab or atezolizumab plus tiragolumab for programmed death-ligand 1-positive recurrent cervical cancer (SKYSCRAPER-04). Int J Gynecol Cancer. 2024 Aug 5;34(8):1140-1148. doi: 10.1136/ijgc-2024-005588.

  PMID: 38858106 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Tiragolumab; atezolizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 9, 2020
• Study Start: June 30, 2020
• Primary Completion: December 8, 2021
• Study Completion: February 24, 2025
• Last Updated: March 12, 2026
• Results First Posted: February 7, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

PA (2); RU (5); FR (5); CO (2); AU (1); TW (5); KR (7); PL (5); IT (3); CA (5); PE (1); US (4); TH (1); ES (3); GB (2); BR (6); ME (1)