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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 : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy 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
Cervical Cancer Drug: Tiragolumab Drug: Atezolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Name: RO7092284

Drug: Atezolizumab
Atezolizumab at a fixed dose of 1200 milligrams (mg) will be administered by intravenous (IV) infusion every 3 weeks (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 milligrams (mg) will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Other Names:
  • RO5541267
  • Tecentriq




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Percentage of Participants With Adverse Events [ Time Frame: Up to 36 months ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. PFS Rate at 6 Months [ Time Frame: 6 months ]
  7. Overall Survival (OS) [ Time Frame: Time from randomization to death from any cause (up to 36 months) ]
  8. OS Rate at 6 Months and 12 Months [ Time Frame: 6 months, 12 months ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. 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) ]
  14. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after at least 1 line of prior therapy 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 at the time of randomization
  • Known human immunodeficiency virus (HIV) infection
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300647


Contacts
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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

Locations
Show Show 75 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04300647    
Other Study ID Numbers: WO42017
2019-004895-21 ( EudraCT Number )
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Atezolizumab
Antineoplastic Agents