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Study on Atezolizumab and Drug Combinations for Advanced Malignancies in Patients from Previous Atezolizumab Trials

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial looks into treating advanced cancers using a combination of therapies. The diseases being studied in this trial include various types of advanced malignancies, which are serious forms of cancer that have progressed to an advanced stage. The study focuses on a therapy that includes a main drug, atezolizumab, and additional drugs being used as comparators. Atezolizumab is a type of drug that helps the immune system attack cancer cells, and it's given to patients intravenously, meaning it's delivered directly into a vein. The additional drugs tested in this extension of the study include Sutent, Paclitaxel, Alecensa, and Cotellic.

The goal of this study is to continue providing the treatment to patients who have already participated in earlier phases of similar studies but still need ongoing therapy since they cannot access these medicines locally. This means the therapy will continue for patients who are still benefiting from it according to assessments by their doctors.

The study does not provide detailed procedures but involves using these medicines to see if the patients continue to respond positively to the treatment therapies. This ongoing treatment will allow the observation of the treatments' effects over a longer period and help determine the best use of these drugs in managing cancer. Some patients might be given a placebo, which is a substance with no therapeutic effect used in trials to test the effectiveness of another drug.

The research process

The trial runs in 5 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, the patient must have signed the extension study informed consent form.

    Eligibility for continuing atezolizumab-based therapy or comparator agent(s) is required, as per the parent study protocol.

    The patient must not have access to the study treatment locally.

  2. Step 2

    Treatment continuation

    The patient will continue treatment with atezolizumab-based therapy or comparator agent(s).

    The first dose in this extension study must be received within 7 days of the treatment interruption window allowed by the parent study.

  3. Step 3

    Medication administration

    The patient will receive atezolizumab as a solution for infusion, administered intravenously.

    Other medications may include sunitinib (oral capsules), alectinib (oral capsules), cobimetinib (oral tablets), vemurafenib (oral tablets), paclitaxel (solution for infusion), venetoclax (oral tablets), and cabozantinib (oral tablets).

    The specific dosage, frequency, and duration of administration will be determined by the study protocol and the investigator's assessment.

  4. Step 4

    Monitoring and assessment

    The patient's response to the treatment will be regularly monitored and assessed by the investigator.

    The continuation of treatment will depend on the clinical benefit derived from the therapy, as assessed by the investigator.

  5. Step 5

    Study duration

    The estimated end date for the study is December 31, 2028.

    The patient will remain in the study as long as they continue to benefit from the treatment and meet the study criteria.

Who can join the trial?

8 criteria

  • Must have signed the extension study Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
  • Eligible to continue receiving atezolizumab-based therapy (a type of cancer treatment) from the previous study, according to the rules of that study.
  • Eligible to continue receiving the comparator agent(s) (other treatments being compared in the study) in a Genentech- or Roche-sponsored study, if these treatments are not available locally.
  • The time between the last dose in the previous study and the first dose in this study must not exceed the allowed break period. The first dose in this study should be within 7 days of the allowed break period.
  • Must still be benefiting from the atezolizumab-based treatment or the comparator treatment at the time of joining this study, as determined by the study doctor.
  • Must be able to follow the study requirements, as judged by the study doctor.
  • Women who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
  • Must agree to follow the study's rules about using birth control.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who are not currently receiving the specific treatment being studied.
  • Patients who have access to the study treatment locally and do not need to join the trial to receive it.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study treatment may not be safe for the baby.
  • Patients who are participating in another clinical trial that could interfere with this study.
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Investigated drugs

Atezolizumab is a medication used in this clinical trial. It is an immunotherapy drug that helps the body's immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing the immune system to better target and destroy cancer cells. This trial aims to provide continued treatment with atezolizumab for patients who were already receiving it in a previous study.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently used in medicine for treating various advanced malignancies, and its effectiveness is well-documented in medical literature. The main therapeutic indication for atezolizumab is to treat certain types of cancer by enhancing the body's immune response against tumor cells. At the molecular level, it works by blocking the interaction between PD-L1, a protein on cancer cells, and PD-1, a receptor on immune cells, thereby allowing the immune system to better attack the cancer. Atezolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Advanced Malignancies – This term refers to cancers that have progressed to a late stage, often spreading beyond their original site to other parts of the body. These malignancies can affect various organs and tissues, leading to complex symptoms depending on the location and extent of the spread. As the disease advances, it may cause significant changes in bodily functions and overall health. The progression can vary widely among individuals, influenced by factors such as the type of cancer, its location, and the patient's overall health. Advanced malignancies often require comprehensive management to address symptoms and maintain quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506184-34-00Protocol codeBO40729Estimated enrolment1 104 patientsSponsorF. Hoffmann-La Roche AG

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