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Study on the Effectiveness of Inavolisib, Atezolizumab, and Entrectinib in Patients with Advanced or Metastatic Solid Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for solid tumors, which are abnormal masses of tissue that can occur in various parts of the body. The study involves several medications, including Inavolisib (also known as GDC-0077), Tecentriq (active substance: Atezolizumab), Rozlytrek (active substance: Entrectinib), Divarasib (also known as GDC-6036), Ipatasertib, Pralsetinib, Camonsertib, Belvarafenib, and Alecensa (active substance: Alectinib). The purpose of the study is to evaluate the effectiveness of these treatments in patients with advanced or metastatic solid tumors that have specific genetic changes or biomarkers.

Participants in the study will receive one of the medications mentioned above, or a placebo, depending on the specific requirements of the trial. The study will be conducted over a period of time, with regular assessments to monitor the response to the treatment. These assessments will help determine how well the treatment is working and will include various tests and evaluations. The study aims to gather information on the objective response rate, which is a measure of how much the tumor shrinks or disappears after treatment, as well as other outcomes like the duration of response and overall survival.

The trial is designed to include patients who have been diagnosed with advanced solid tumors that cannot be surgically removed or have spread to other parts of the body. The study will also consider the safety and side effects of the treatments, ensuring that participants are closely monitored throughout the trial. This research is part of a larger effort to develop more effective treatments for solid tumors and improve the quality of life for patients with these conditions.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, a diagnosis of advanced or metastatic solid tumors is confirmed.

    Eligibility is based on specific criteria, including measurable disease and adequate organ function.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of medications tailored to the specific tumor type and genetic markers.

    Medications include inavolisib (oral film-coated tablet), atezolizumab (IV infusion), and entrectinib (oral hard capsule).

  3. Step 3

    Medication schedule

    The dosage and frequency of each medication depend on the specific treatment plan designed for the patient.

    The duration of administration is determined by the response to treatment and the study protocol.

  4. Step 4

    Monitoring and assessment

    Regular monitoring is conducted to assess the effectiveness of the treatment.

    Assessments include imaging studies and laboratory tests to evaluate tumor response.

  5. Step 5

    Response evaluation

    The response to treatment is evaluated using criteria such as RECIST v1.1, which measures changes in tumor size.

    The primary goal is to determine the objective response rate (ORR) and other outcomes like progression-free survival (PFS).

  6. Step 6

    Continuation or adjustment of treatment

    Based on the evaluation results, the treatment plan may be continued, adjusted, or stopped.

    Decisions are made to optimize the therapeutic benefit and manage any side effects.

  7. Step 7

    End of study participation

    Participation in the study concludes when the treatment is no longer beneficial or the study period ends.

    Final assessments are conducted to gather data on the long-term effects and outcomes of the treatment.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of advanced and unresectable or metastatic solid cancer. This means the cancer is in a stage that cannot be removed by surgery and may have spread to other parts of the body.
  • The patient must have a measurable disease. This means the cancer can be measured using specific criteria like RECIST v1.1, RANO, or INRC, which are guidelines used to assess how the cancer responds to treatment.
  • The patient must have a certain level of physical ability. For those aged 18 and older, this is measured by the ECOG Performance Status, which ranges from 0 (fully active) to 2 (some limitations but able to care for oneself). For those aged 16 to under 18, a Karnofsky score of 50% or higher is required, and for those under 16, a Lansky score of 50% or higher is needed. These scores help determine how well a person can perform daily activities.
  • The patient must have adequate blood and organ function. This means the patient's blood and organs are working well enough to handle the treatment.
  • The patient must have experienced disease progression on previous treatment, or have a disease that has not been treated before with no other acceptable treatment options available.
  • The patient must have adequately recovered from their most recent cancer treatment, whether it was a systemic treatment (affecting the whole body) or a local treatment (targeting a specific area).

Who cannot join the trial?

7 criteria

  • Patients who do not have **solid tumors**. Solid tumors are abnormal masses of tissue that usually do not contain liquid areas.
  • Patients who do not have **advanced or metastatic** solid tumors. Advanced means the cancer has spread to other parts of the body, and metastatic means the cancer has spread from where it started to other parts of the body.
  • Patients who do not have **alteration/biomarker-positive** tumors. This means the tumor must have specific changes or markers that the study is looking for.
  • Patients who are not assessed by **RECIST v1.1**. RECIST is a set of rules that help doctors measure how well a cancer treatment is working.
  • Patients who are not within the specified **age ranges**. The study includes certain age groups, and patients must fall within these groups to participate.
  • Patients who are not part of the specified **clinical trial groups**. The study is looking for specific groups of patients, and participants must belong to these groups.
  • Patients who are not part of the **vulnerable population**. This means the study is looking for patients who may have special needs or circumstances.
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Investigated drugs

  • Immunotherapy

    is a type of cancer treatment that helps your immune system fight cancer. It uses substances made by the body or in a laboratory to improve or restore immune system function. In this trial, immunotherapy is being used to target specific biomarkers in tumors, aiming to enhance the body's natural defenses against cancer cells.

  • Targeted Therapy

    involves using drugs or other substances to precisely identify and attack cancer cells, usually while doing little damage to normal cells. This therapy focuses on the specific genetic changes that contribute to cancer growth and survival. In this trial, targeted therapy is being used to treat patients with specific genetic alterations in their tumors, aiming to block the growth and spread of cancer cells.

What is already known about the treatment

Immunotherapy Agent – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic solid tumors. The main therapeutic indication is for patients with specific genetic alterations or biomarkers in their tumors. At the molecular level, it works by enhancing the body's immune response to target and destroy cancer cells. It is classified as an immunotherapy, which is a type of treatment that uses the body's immune system to fight cancer.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they may invade nearby tissues and organs, potentially causing physical symptoms depending on their location. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they have the potential to spread and invade other tissues. The progression of solid tumors can vary widely depending on the type and location of the tumor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507418-28-00Protocol codeBO41932Estimated enrolment906 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).