A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy

Official Title

A Phase II, Multicentre, Randomized, Placebo-Controlled, Double-Blind Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy

Summary:

This is a Phase II, multicentre, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting and who are ineligible to receive cisplatin-based therapy.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS)
• Overall Survival (OS)

Secondary Outcome:

• Objective Response (OR) According to RECIST v1.1
• Duration of Objective Response (DOR) According to RECIST v1.1
• Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)
• Percentage of Participants Reporting Symptom Interference with Daily Living at the Time of Progression According to the MDASI
• Percentage of Participants With Adverse Event (AEs)
• Area under the plasma drug concentration-time curve (AUC) of MOXR0916 and Atezolizumab
• Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab
• Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab
• Clearance of MOXR0916 and Atezolizumab
• Percentage of Participants with Anti-Therapeutic antibodies (ATAs) to MOXR0916 and Atezolizumab

The study design has been amended after the decision to prematurely stop patient accrual due to enrollment challenges. As only 5 participants were enrolled, the study blinding will not be maintained, and placebo infusions will not be administered. Patients assigned to the MOXR0916 arm may continue study treatment with the combination of atezolizumab and MOXR0916 or with atezolizumab alone based on a discussion of benefit and risk with the treating investigator.

View this trial on ClinicalTrials.gov