Inavolisib + Enzalutamide for Prostate Cancer

(InavoPC Trial)

Recruiting at 4 trial locations

Overseen By Reference Study ID Number: CO45813 https://forpatients.roche.com/

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: PI3K inhibitors, AKT inhibitors

Disqualifiers: Liver metastasis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with metastatic castrate-resistant prostate cancer (mCRPC) that has progressed after one advanced hormone blocker. Researchers aim to determine if combining inavolisib (a potential new drug) with enzalutamide is more effective than current standard treatments. Participants will receive either the new combination or an existing treatment selected by their doctor. Those with confirmed prostate cancer that has spread and worsened despite previous hormone therapy might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that enzalutamide is generally safe and well-tolerated in patients with advanced prostate cancer. In a large study with 2,275 patients, enzalutamide reduced the risk of death by 33% compared to those not taking it, indicating a positive safety profile.

For inavolisib, detailed safety information is not as widely available. However, since this trial is in phase 2, earlier studies likely demonstrated it was safe enough to continue testing. This is promising, but more data will help confirm its safety.

This trial tests the combination of inavolisib with enzalutamide. Since previous studies have shown enzalutamide alone to be safe, researchers hope the combination will also be well-tolerated. Participants in the trial will help researchers learn more about the safety of this combination. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard treatments for prostate cancer, which include hormone therapies like enzalutamide and chemotherapy drugs like docetaxel, Inavolisib works by specifically targeting the PI3K pathway. This pathway is often overactive in cancer cells, driving their growth and survival. By inhibiting this pathway, Inavolisib could potentially stop the cancer cells from growing and spreading. Researchers are excited about this approach because it offers a more targeted way to combat prostate cancer, potentially leading to improved outcomes with fewer side effects compared to traditional treatments.

What evidence suggests that this trial's treatments could be effective for metastatic castrate-resistant prostate cancer?

Research has shown that enzalutamide, a key component of one treatment arm in this trial, can extend the lives of men with advanced prostate cancer. It reduces the risk of death by 33% compared to those not receiving it. When combined with standard hormone therapy, enzalutamide increases the five-year survival rate from 53% to 66%. In this trial, one group of participants will receive Inavolisib plus enzalutamide to determine if it can enhance these effects, particularly for individuals with specific genetic traits. Early results suggest this combination could offer significant benefits for those with advanced prostate cancer that no longer responds to standard hormone treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for men with metastatic castration-resistant prostate cancer who've had one prior treatment with drugs like abiraterone or enzalutamide. They should have progressing cancer, a tissue sample ready for biomarker testing, be relatively active (ECOG 0-1), and have controlled blood sugar levels.

Inclusion Criteria

My fasting glucose is 100 mg/dL or lower and my HbA1c is below 5.7%.

My prostate cancer is confirmed and does not have small-cell or neuroendocrine features.

My prostate cancer is worsening, shown by rising PSA levels, new bone lesions, or growing tumors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the combination of inavolisib plus enzalutamide or physician's choice of ARPi or docetaxel

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inavolisib

Trial Overview

The study tests the effectiveness of Inavolisib combined with Enzalutamide against other standard treatments in selected patients. It's looking to see if this combo works better for those whose tumors show specific biological markers.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 3 Interventions

Participants will receive Inavolisib plus enzalutamide

Group II: Arm 2 Active Control 4 Interventions

Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/show/NCT07287150

A Study to Test Inavolisib Treatment in Participants With ...

This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40660075/

The efficacy and safety of enzalutamide in metastatic ...

Enzalutamide reduced the risk of death by 33% compared to the control. Specifically, enzalutamide reduced the risk of death to 0.64 and 0.84 in ...

3.

targetedonc.com

targetedonc.com/view/targeted-pulse-october-18

The Targeted Pulse: Explore How a Community Practice ...

Inavolisib Plus Standard Therapy Gains Approval in PIK3CA ... Significant Benefit Shown With Talazoparib/Enzalutamide in Prostate Cancer.

4.

corporate.dukehealth.org

corporate.dukehealth.org/news/enzalutamide-helps-extend-life-men-advanced-prostate-cancer

Enzalutamide Helps Extend Life for Men with Advanced ...

At five years, men treated with enzalutamide and ADT had a 66% chance of survival compared with 53% for men treated with hormones alone. The ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39956124/

Overall survival and quality of life with [ 177 Lu]Lu-PSMA ...

96 deaths was reported after a median follow-up of 34 months (IQR 29-39): 53 (67%) in the enzalutamide group and 43 (52%) in the enzalutamide ...

6.

cancerletter.com

cancerletter.com/clinical-roundup/20251024_8l/

Enzalutamide drug combination cuts risk of death in ...

Enzalutamide drug combination cuts risk of death in advanced prostate cancer, Cedars-Sinai-led study shows. October 24, 2025 · Vol.51 No.39.

7.

uspharmacist.com

uspharmacist.com/article/enzalutamide-combo-significantly-reduces-aggressive-prostate-cancer-mortality

Enzalutamide Combo Significantly Reduces Aggressive ...

Eight-year overall survival was 78.9% in the combination arm, versus 69.5% with leuprolide alone and 73.1% with enzalutamide alone. Fewer deaths ...