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 — 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.
  • 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.

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

FacilityCityStateZIPSite coordinators
Arizona Oncology AssociatesPhoenixArizona85016-
Kaiser Permanente - IrvineIrvineCalifornia92616-
Augusta UniversityAugustaGeorgia30912-
Oncology Associates of Oregon, P.CEugeneOregon97401-

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