Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

Conditions

• Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
• Carboplatin — DRUG
  Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL\*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
• Gemcitabine — DRUG
  Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
• Placebo — OTHER
  Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
• Cisplatin — DRUG
  Cisplatin will be administered at a dose of 70 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.

Study Details

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

Key Dates

Start date

Jun 30, 2016

Status verified

Feb 2025

Primary completion

Aug 31, 2022

Completion

Feb 12, 2024

Study Design

Enrollment

1,213 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
  Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
• Placebo Comparator: Placebo+Gemcitabine+Carboplatin/Cisplatin
  Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
• Experimental: Atezolizumab Monotherapy
  Eligible participants will receive open-label atezolizumab as monotherapy.

Primary Outcome Measure

Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm [ Time Frame: Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months) ]

Locations (18)

Find similar trials in Rogers, AR

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