Recruiting
Phase 2

Inavolisib & Enzalutamide

Sponsor:

Hoffmann-La Roche

Code:

NCT07287150

Conditions

Metastatic Castration-Resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inavolisib

Enzalutamide

Abiraterone

Docetaxel

Study Details

Brief summary:

This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Study ID

NCT07287150

Start date

Mar 11, 2026

Status verified date

Sep, 2026

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features
  • Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA >=1 ng/mL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Bone disease progression, defined by PCWG3 criteria, with two or more new metastatic bone lesions on a whole-body radionuclide bone scan
  • Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for hormone- sensitive prostate cancer (HSPC) or CRPC
  • Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Fasting glucose <100 mg/dL and HbA1c < 5.7%

Exclusion Criteria:

  • Presence of liver metastasis
  • Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K/AKT/mTOR pathway
  • Type 1 or Type 2 diabetes mellitus
  • Prior treatment for mCRPC with cytotoxic chemotherapy or novel hormonal treatments (e.g., androgen receptor degraders, CYP11 inhibitors), with the following treatments permitted: Prior docetaxel in mHSPC, providing no evidence of disease progression occurred during treatment or within 6 months of treatment completion; Prior docetaxel in the adjuvant or neoadjuvant setting providing no evidence of disease progression occurred during treatment or within 12 months of treatment completion; Prior treatment with sipuleucel-T, with the last dose administered >28 days prior to start of treatment; Prior PARPi therapy, as per local prescribing information, with the last dose administered >14 days prior to start of treatment; One prior RLT or radiotherapeutic agent (e.g., PSMA-targeted RLT, Radium 223) with the last dose administered >8 weeks prior to start of treatment
  • Other concurrent anti-cancer therapy except for androgen deprivation therapy
  • Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment
  • Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Participants will receive Inavolisib plus enzalutamide

active comparator: Arm 2

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

Interventions

Inavolisib

Inavolisib will be administered orally as per the schedule specified in the protocol.

Enzalutamide

Enzalutamide will be administered orally as per the schedule specified in the protocol.

Abiraterone

Abiraterone will be administered orally as per the schedule specified in the protocol.

Docetaxel

Docetaxel will be administered intravenously as per the schedule specified in the protocol.

Primary outcome measure

  • Radiographic Progression-free Survival (rPFS) [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

Locations

VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDS

Recruiting

Los Angeles, California, United States, 90073-1003

UCSF

Recruiting

San Francisco, California, United States, 94115

Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242-1009

Montefiore Einstein Cancer Center

Recruiting

The Bronx, New York, United States, 10461

Lifespan Cancer Institute

Recruiting

Providence, Rhode Island, United States, 02903-4923

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572-4607

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Centre de recherche du Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-03.