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 |
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Recruitment Status :
Active, not recruiting
First Posted : March 9, 2020
Last Update Posted : May 13, 2024
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Cancer | Drug: Tiragolumab Drug: Atezolizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 172 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 |
| Actual Study Start Date : | June 30, 2020 |
| Actual Primary Completion Date : | December 8, 2021 |
| Estimated Study Completion Date : | December 30, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Cervical Cancer
Drug Information
available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Tiragolumab plus Atezolizumab
Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
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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:
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Experimental: Atezolizumab
Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
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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:
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Primary Outcome Measures :
- Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) [ Time Frame: From randomization up to approximately 36 months ]
Secondary Outcome Measures :
- 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 approximately 36 months) ]
- IRC-Assessed Disease Control Rate (DCR) [ Time Frame: From randomization up to approximately 36 months ]
- Investigator-Assessed Best Clinical Response (BCR) Rate [ Time Frame: 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) ]
- 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) ]
- IRC-Assessed PFS Rate at 6 Months [ Time Frame: At 6 months post-randomization ]
- 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: 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
Information from the National Library of Medicine
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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 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
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
Locations
Show 66 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| 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: | May 13, 2024 |
| Last Verified: | May 2024 |
| 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.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). |
| 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 |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Atezolizumab Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Antineoplastic Agents |