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

Sponsor
Hoffmann-La Roche
Study ID
NCT07323576
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inavolisib — DRUG
    Participants will receive Inavolisib as per the schedule mentioned in the protocol.
  • Bevacizumab — DRUG
    Participants will receive Bevacizumab as per the schedule mentioned in the protocol.
  • FOLFOX — DRUG
    Participants will receive FOLFOX as per the schedule mentioned in the protocol.
  • FOLFIRI — DRUG
    Participants will receive FOLFIRI as per the schedule mentioned in the protocol.
  • Placebo — DRUG
    Participants will receive Placebo as per the schedule mentioned in the protocol.

Study Details

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.

Key Dates

First listed
Jan 7, 2026
Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Mar 1, 2029
Completion
Mar 31, 2031

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + Inavolisib
    Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Inavolisib.
  • Placebo Comparator: Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + Placebo
    Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Placebo.
  • Experimental: Safety Run-in Period: FOLFOX or FOLFIRI + Bevacizumab + Inavolisib
    Participants will receive either FOLFIRI or FOLFOX and Bevacizumab along with Inavolisib.

Primary Outcome Measure

Safety Run-in Period: Percentage of Participants With Adverse Events (AEs) [ Time Frame: Approximately 4 Years ]

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