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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hospital Universitario Hm Sanchinarro Madrid Spain
Lungenfachklinik Immenhausen Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Asklepios Klinik Gauting GmbH Gauting Germany
Masarykuv Onkologicky Ustav Brno-Stred Czechia
University Hospital Bratislava Bratislava Slovakia
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Oncomed S.R.L. Timisoara Romania
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Vrije Universiteit Brussel Jette Belgium
Metropolitan Hospital Athens Greece
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy Otwock Poland
Dsmgiqelvwoq Cslhmyy Obfivrjgd Pnzhmrzjbouj I Hofkdvbihon Wroclaw Poland
Aghrithjsm Prdatsxf Hmdzlgze Dp Mqetqvwpm Marseille France
Rafor Ahmqfmor kxqaossk ugmgmejldxxkj srjhxhgs Sdw Riga Latvia
Ngcgiwao Ikwarybj Otpwcvumr Ibi Mohry Sftrsygqcztikgoqrhmcgvmpepcl Ijoddabf Bgmjxgrc Cracow Poland
Koiqdlzm Eqcmkhzxvxkbviaadlejjwik Hfztmsbuwbwhixjfm Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.12.2018
Czechia Czechia
Not recruiting
31.12.2018
France France
Not recruiting
31.12.2018
Germany Germany
Not recruiting
31.12.2018
Greece Greece
Not recruiting
31.12.2018
Hungary Hungary
Not recruiting
31.12.2018
Latvia Latvia
Not recruiting
31.12.2018
Poland Poland
Not recruiting
31.12.2018
Romania Romania
Not recruiting
31.12.2018
Slovakia Slovakia
Not recruiting
31.12.2018
Spain Spain
Not recruiting
31.12.2018

Trial locations

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.

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 ID:
2023-506184-34-00
Protocol code:
BO40729
Trial Phase:
Therapeutic confirmatory (Phase III)

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