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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Rigshospitalet	Copenhagen	Denmark
Universita Degli Studi Di Brescia	Brescia	Italy
Grand Hopital De Charleroi	Charleroi	Belgium
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Cfsqabcxx Uqepqszbyijpzu Sfptckruw	Woluwe-Saint-Lambert	Belgium
Cxfrob Lenn Bycebg	Lyon	France
Uyizuyobpylbszjabluhk Exezj Ael	Essen	Germany
Amjvzdodgb Pxfpgfpz Hchgjdvj Dl Mhslwyyrv	Marseille	France
Azcgxqw Odhmlesmngw Uccpvtlkvajvo Sjakla	Siena	Italy
Atrkdzc Ojhsfwjapcv Ukoqsaarzjzbw Cphgmiadzhma Dqjww Smnowh E Diydy Sphqihf Db Tkspen	Turin	Italy
Nkccbwbn Izzpgwnk Otbovoykg Inf Mtddy Sxkarkwvzbfolellclhemuvmgxcl Icnhiffz Bgldozaa	Cracow	Poland
Urnkgurksbiqqa Cmbidoz Kppiduzus	Gdansk	Poland
Uooyaevuvj Ol Ahzepdc	Edegem	Belgium
Flcnalate Pgas La Iclkmzreoszod Bcqajpnfm Don Hnrxhbvc Uwconmacgtarg Lb Pcu	Madrid	Spain
Hkxlqnpa Vzoi dlqzqmkw	Barcelona	Spain
Cdkyjl Oyhcw Libkhdo	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	29.04.2021
Denmark	Not recruiting	29.04.2021
France	Not recruiting	29.04.2021
Germany	Not recruiting	29.04.2021
Italy	Not recruiting	29.04.2021
Poland	Not recruiting	29.04.2021
Portugal	Not recruiting	29.04.2021
Spain	Not recruiting	29.04.2021

Trial locations

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.

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 ID:

2023-507418-28-00

Protocol code:

BO41932

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?