NCT07323576

A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib With Bevacizumab Plus Folfox or Folfiri as First Line Therapy in Patients With PIK3CA-Mutated Metastatic Colorectal Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a blinded Phase 2 study designed to evaluate the safety and efficacy of inavolisib with bevacizumab and chemotherapy, in participants with metastatic colorectal cancer (mCRC) whose tumors have a PIK3CA mutation. The study has a safety run-in period followed by a randomized period.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Inavolisib	Participants will receive Inavolisib as per the schedule mentioned in the protocol.
DRUG	Bevacizumab	Participants will receive Bevacizumab as per the schedule mentioned in the protocol.
DRUG	FOLFOX	Participants will receive FOLFOX as per the schedule mentioned in the protocol.
DRUG	FOLFIRI	Participants will receive FOLFIRI as per the schedule mentioned in the protocol.
DRUG	Placebo	Participants will receive Placebo as per the schedule mentioned in the protocol.

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-03-01
• Completion: 2031-03-31
• First posted: 2026-01-07
• Last updated: 2026-02-09

Regulatory

• FDA-regulated drug study