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Trial record 1 of 1 for:    NCT04300647
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A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1−Positive Cervical Cancer (SKYSCRAPER-04)

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ClinicalTrials.gov Identifier: NCT04300647
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 6, 2020
First Posted Date  ICMJE March 9, 2020
Last Update Posted Date July 20, 2020
Actual Study Start Date  ICMJE June 30, 2020
Estimated Primary Completion Date July 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) [ Time Frame: From randomization up to 36 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
Objective Response Rate (ORR) [ 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 36 months) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
  • Percentage of Participants With Adverse Events [ Time Frame: 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 36 months) ]
  • IRC-Assessed Disease Control Rate (DCR) [ Time Frame: From randomization up to 36 months ]
  • Investigator-Assessed Best Clinical Response (BCR) Rate [ Time Frame: From randomization up to 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 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 36 months) ]
  • IRC-Assessed PFS Rate at 6 Months [ Time Frame: 6 months ]
  • Overall Survival (OS) [ Time Frame: From randomization to death from any cause (up to 36 months) ]
  • OS Rate at 6 Months and 12 Months [ Time Frame: 6 months, 12 months ]
  • Minimum Serum Concentration (Cmin) of Tiragolumab [ Time Frame: 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) ]
  • Maximum Serum Concentration (Cmax) of Tiragolumab [ Time Frame: 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) ]
  • Cmin of Atezolizumab [ Time Frame: 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) ]
  • Cmax of Atezolizumab [ Time Frame: 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) ]
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [ Time Frame: 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) ]
  • Percentage of Participants With ADAs to Atezolizumab [ Time Frame: 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • Percentage of Participants With Adverse Events [ Time Frame: Up to 36 months ]
  • 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 36 months) ]
  • Disease Control Rate (DCR) [ Time Frame: First occurrence of a documented control date to the date of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
  • Best Clinical Response (BCR) Rate [ Time Frame: First occurrence of a documented clinical response to the date of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
  • Progression-Free Survival (PFS) [ Time Frame: Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 36 months) ]
  • PFS Rate at 6 Months [ Time Frame: 6 months ]
  • Overall Survival (OS) [ Time Frame: Time from randomization to death from any cause (up to 36 months) ]
  • OS Rate at 6 Months and 12 Months [ Time Frame: 6 months, 12 months ]
  • Minimum Serum Concentration (Cmin) of Tiragolumab [ Time Frame: 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) ]
  • Maximum Serum Concentration (Cmax) of Tiragolumab [ Time Frame: 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) ]
  • Cmin of Atezolizumab [ Time Frame: 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) ]
  • Cmax of Atezolizumab [ Time Frame: 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) ]
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [ Time Frame: 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) ]
  • Percentage of Participants With ADAs to Atezolizumab [ Time Frame: 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1−Positive Cervical Cancer
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • 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 Name: 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
Study Arms  ICMJE
  • Experimental: Tiragolumab plus Atezolizumab
    Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    Interventions:
    • Drug: Tiragolumab
    • Drug: Atezolizumab
  • Experimental: Atezolizumab
    Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    Intervention: Drug: Atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2020)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2023
Estimated Primary Completion Date July 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after 1-2 lines of prior systemic chemotherapy 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
  • Any 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: WO42017 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Costa Rica,   France,   Italy,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Spain,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04300647
Other Study ID Numbers  ICMJE WO42017
2019-004895-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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/members/ourmembers/). 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).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP