A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT04300647
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tiragolumab — DRUGTiragolumab 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 — DRUGAtezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Study Details
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).
Key Dates
- Start date
- Jun 30, 2020
- Status verified
- Feb 2026
- Primary completion
- Dec 8, 2021
- Completion
- Feb 24, 2025
Study Design
- Enrollment
- 172 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Tiragolumab plus AtezolizumabParticipants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
- Experimental: AtezolizumabParticipants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Primary Outcome Measure
Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) [ Time Frame: From randomization up to approximately 17 months ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arizona Oncology Associates | Phoenix | Arizona | 85016 | - |
| Kaiser Permanente - Irvine | Irvine | California | 92616 | - |
| Augusta University | Augusta | Georgia | 30912 | - |
| Oncology Associates of Oregon, P.C | Eugene | Oregon | 97401 | - |
Related coverage on Hipa.ai
- Atezolizumab Combination Shows Improved Response in Cervical Cancer TrialAtezolizumab · Feb 7, 2025 · ClinicalTrials.gov
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