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Atezolizumab + Chemotherapy for Bladder Cancer
(IMvigor130 Trial)

Recruiting at 351 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with untreated advanced urothelial carcinoma, who haven't had chemotherapy for this condition and are eligible to receive platinum-based chemotherapy. They must have measurable disease, agree to use effective contraception, and not be pregnant or breastfeeding. Prior local treatments are okay if completed at least 4 weeks before the study starts.

Inclusion Criteria

I had chemo for bladder cancer over a year ago and haven't had treatment since it came back.

I completed bladder cancer treatment at least 4 weeks ago.

I have not had chemotherapy for my advanced urinary cancer that cannot be removed by surgery.

See 8 more

Exclusion Criteria

My cancer has spread to the lining of my brain and spinal cord.

I have previously been treated with specific immune therapy drugs.

I haven't had severe infections or taken antibiotics in the last 4 weeks.

See 22 more

Treatment Details

Interventions

Atezolizumab (Monoclonal Antibodies)
Carboplatin (Alkylating agents)
Cisplatin (Alkylating agents)
Gemcitabine (Anti-metabolites)
Placebo (Other)

Trial OverviewThe study tests Atezolizumab alone and combined with platinum-based chemotherapy (Carboplatin or Cisplatin) plus Gemcitabine against just the chemotherapy in patients with advanced bladder cancer. It's a Phase III trial where participants are randomly assigned to different treatment groups.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Atezolizumab+Gemcitabine+Carboplatin/CisplatinExperimental Treatment4 Interventions

Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Group II: Atezolizumab MonotherapyExperimental Treatment1 Intervention

Eligible participants will receive open-label atezolizumab as monotherapy.

Group III: Placebo+Gemcitabine+Carboplatin/CisplatinPlacebo Group4 Interventions

Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Atezolizumab + Chemotherapy for Bladder Cancer (IMvigor130 Trial)