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Colorectal CancerPhase 2INAVO-CRCNCT07323576

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 2 study testing Inavolisib, Bevacizumab and FOLFOX in people with Colorectal Cancer, run by Hoffmann-La Roche.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Inavolisib, Bevacizumab and FOLFOX
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Feb 2026to 31 Mar 2031
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) <=1
  • Histologically confirmed adenocarcinoma originating in the colon or rectum of the Stage 4 ( treatment plan does not include resection or curative ablation) per American Joint Committee on Cancer (AJCC) v8
  • Measurable disease per RECIST v1.1
  • No prior systemic therapy in the metastatic setting
  • Confirmation of biomarker eligibility: documentation of a PIK3CA mutation from either central testing of tissue, or from a validated historically obtained (pre-existing) test of tumor tissue or blood may be used to confirm eligibility
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
  • Agreement to adhere to the contraception requirements

Who cannot join

  • Biomarker eligibility as per definition
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry or any history of Type 1 diabetes
  • Residual Grade 2 or higher neuropathy due to prior oxaliplatin exposure (unless the participant is planned to be treated with FOLFIRI)
  • Symptomatic, untreated, or actively progressing CNS metastases
  • History of gastrointestinal (GI) fistula, GI perforation, or intra-abdominal abscess within 6 months prior to Day 1 of Cycle 1
  • Treatment with strong cytochrome P450 (CYP) 3A4 inducers or strong CYP3A4 inhibitors within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment (only for patients who will receive FOLFIRI)
  • Known HIV positive status with exceptions for well controlled and on stable treatment
  • History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death

About this study

Official title: 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

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.

Being tested
Inavolisib, Bevacizumab, FOLFOX, FOLFIRI, Placebo
Keywords
PIK3CA-mutated Colorectal Cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

    Also called Itovebi, GDC-0077

    Participants will receive Inavolisib as per the schedule mentioned in the protocol.

  • BevacizumabDrug

    Also called Avastin

    Participants will receive Bevacizumab as per the schedule mentioned in the protocol.

  • FOLFOXDrug

    Participants will receive FOLFOX as per the schedule mentioned in the protocol.

  • FOLFIRIDrug

    Participants will receive FOLFIRI as per the schedule mentioned in the protocol.

  • PlaceboDrug

    Participants will receive Placebo as per the schedule mentioned in the protocol.

Study groups in NCT07323576
Study groupRoleWhat they receive
Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + InavolisibExperimentalParticipants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Inavolisib.
Receives: Drug: Inavolisib; Drug: Bevacizumab; Drug: FOLFOX; Drug: FOLFIRI
Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + PlaceboPlacebo comparatorParticipants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Placebo.
Receives: Drug: Bevacizumab; Drug: FOLFOX; Drug: FOLFIRI; Drug: Placebo
Safety Run-in Period: FOLFOX or FOLFIRI + Bevacizumab + InavolisibExperimentalParticipants will receive either FOLFIRI or FOLFOX and Bevacizumab along with Inavolisib.
Receives: Drug: Inavolisib; Drug: Bevacizumab; Drug: FOLFOX; Drug: FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Run-in Period: Percentage of Participants With Adverse Events (AEs)

    Measured: Approximately 4 Years

  2. Percentage of Participants With an Objective Response Rate

    The percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1.)

    Measured: From Baseline Untill Radiographic Disease Progression (Approximately 4 Years)

Secondary outcomes (9)

  1. Progression-free Survival (PFS)

    Time from randomization to death from any cause or the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 (whichever occurs first)

    Measured: From Baseline Untill Radiographic Disease Progression (up to Approximately 4 Years)

  2. Randomized Phase: Overall Survival (OS)

    Defined as the time from randomization to death from any cause

    Measured: From Baseline Untill Death (up to Approximately 4 Years)

  3. Randomized Phase: Disease Control Rate (DCR)

    Defined as the percentage of participants with stable disease for >=12 weeks or a CR or PR as determined by the investigator according to RECIST v1.1

    Measured: From Baseline Untill Disease Progression (up to Approximately 4 Years)

  4. Randomized Phase: Duration of Response (DOR)

    Defined as the time from the first occurrence of a documented confirmed OR to death from any cause or the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, (whichever occurs first)

    Measured: From Baseline Untill Disease Progression or Death (up to Approximately 4 Years)

  5. Randomized Phase: Percentage of Participants With AEs

    Measured: From Baseline up to 90 Days After the Final Dose of study treatment or Until Initiation of Another Anti-cancer Therapy (up to Approximately 4 Years)

  6. Percentage of Participants With Symptomatic Treatment Toxicities as Assessed by National Cancer Institute Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)

    Measured: Up to Approximately 4 Years

  7. Percentage of Participants Troubled by Treatment Symptoms, as Assessed by Single Item European Organisation for Research and Treatment of Cancer Item Library 46 (EORTC IL46)

    Measured: Up to Approximately 4 Years

  8. Change From Baseline in Symptomatic Treatment Toxicities as Assessed by PRO-CTCAE

    Measured: Baseline up to Approximately 4 Years

  9. Change From Baseline in Treatment Side-effect Bother as Assessed by EORTC IL46 item

    Measured: Baseline up to Approximately 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion31 Mar 2031 (estimated)

Why it stopped: Sponsor's decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07323576
Sponsor's protocol ID
WO46300
Other IDs
2025-523014-84-00, 2025
Acronym
INAVO-CRC
Status last verified
Feb 2026
First submitted
6 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inavolisib, Bevacizumab and FOLFOX in people with Colorectal Cancer, run by Hoffmann-La Roche.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Run-in Period: Percentage of Participants With Adverse Events (AEs) (time frame: Approximately 4 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07323576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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