Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• XL092 — DRUG
  Supplied as tablets; administered orally daily.
• Atezolizumab — DRUG
  Supplied as 1200 milligrams (mg)/20 milliliter (mL) vials; administered as a 1200 mg intravenous (IV) infusion once in a 3-week cycle (q3w).
• Regorafenib — DRUG
  Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.

Study Details

The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.

Key Dates

Start date

Sep 7, 2022

Status verified

Oct 2025

Primary completion

May 31, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

901 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: XL092 + Atezolizumab
  Participants with mCRC will receive XL092 + atezolizumab.
• Active Comparator: Regorafenib
  Participants with mCRC will receive active comparator of regorafenib.

Primary Outcome Measure

Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants [ Time Frame: Up to 32 months ]

Locations (45)

Find similar trials in Jonesboro, AL

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