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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

NCT07323576 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-02-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2029-03-01
Completion
2031-03-31
FDA Drug
Yes

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07323576 on ClinicalTrials.gov