Study of Sotorasib Alone and Combined with Pembrolizumab in Adult Patients with Advanced Solid Tumors Having KRAS p.

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What is this study about?

This study focuses on patients with advanced solid tumors and non-small cell lung cancer (NSCLC) that have a specific genetic change called KRAS p.G12C mutation. The main purpose is to test a new medication called sotorasib (also known as AMG 510), which is given as a tablet taken by mouth. The study will look at how safe the medication is and how well it works in treating these types of cancer.

The research involves different groups of patients who will receive different treatments. Some patients will take sotorasib alone, while others will receive it in combination with another cancer medication called pembrolizumab. The study includes patients with various types of solid tumors, including colorectal cancer. Different doses of the medication will be tested, including once-daily and twice-daily dosing schedules.

Throughout the study, doctors will monitor patients’ responses to treatment using various medical tests including computed tomography (CT) and magnetic resonance imaging (MRI) scans. They will track how the tumors respond to treatment and watch for any side effects. The study will also look at how the medication moves through the body and how it affects patients’ quality of life and cancer-related symptoms.

1 Initial eligibility verification

Your eligibility for the study will be confirmed based on two main criteria:

– Age requirement: you must be 18 years or older

– Medical condition: you must have a documented locally-advanced or metastatic cancer with confirmed KRAS p.G12C mutation

2 Treatment administration

You will receive sotorasib (AMG 510) treatment in one of several possible ways:

– Once daily dosing

– Twice daily dosing

– Once daily dosing with food

Some participants may receive sotorasib in combination with another medication called pembrolizumab, depending on their specific treatment group

3 Monitoring and assessments

Throughout the study, you will undergo regular health checks including:

– Physical examinations

– Vital signs measurements

– Heart monitoring (ECG)

– Laboratory tests

– Imaging scans (CT or MRI) to assess your response to treatment

4 Response evaluation

Your response to treatment will be evaluated through:

– Regular imaging scans at least every 4 weeks after initial response

– Assessment of any changes in tumor size

– Monitoring of any side effects

– Evaluation of your overall health status

5 Study duration

The study is scheduled to run from August 2018 to May 2027

Your individual participation duration will depend on your response to treatment and overall health status

Who Can Join the Study?

Must be 18 years or older
Must have a confirmed diagnosis of advanced or metastatic cancer (cancer that has spread beyond its original location)
Must have a specific genetic mutation called KRAS p.G12C in their tumor, which must be confirmed through laboratory testing
Both men and women can participate
Must have locally advanced cancer (cancer that has grown into nearby tissues) or metastatic cancer (cancer that has spread to other parts of the body)

Who Cannot Join the Study?

History of treatment with any KRAS G12C inhibitor (medications targeting specific genetic mutation)
Current treatment with medications that strongly affect liver enzymes
Active brain metastases (cancer that has spread to the brain) that are not stable
History of other cancers within the past 5 years, except for successfully treated skin cancer or early-stage cancer
Significant heart problems, including:
- Heart attack within past 6 months
- Unstable heart rhythm problems
- Uncontrolled high blood pressure
Active infections requiring treatment
Known HIV infection (human immunodeficiency virus)
Active hepatitis B or C infection (liver infections)
Major surgery within 28 days before starting the study
Pregnancy or breastfeeding
Any medical condition that could interfere with the study treatment or affect patient safety
Unable to swallow oral medications
Known allergies to the study medication or its components

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria
Katholieke Universiteit te Leuven	Leuven	Belgium
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Krankenhaus Nord Klinik Floridsdorf	Vienna	Austria
Universitaetsklinikum Krems	Krems An Der Donau	Austria
Henry Dunant Hospital Center	Athens	Greece
Hospital General Universitario De Valencia	Valencia	Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Tbvzmzkmsf Cuwysj Hdmxesai	Thessaloniki	Greece
Udokgqjkvb Ol Azpjift	Edegem	Belgium
Ibacxvyw Czdnhm Dzrpmhfdmtrrepbjb	L'hospitalet De Llobregat	Spain
Ihuzlapz Brspbeko	Bordeaux	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	28.08.2018
Belgium	Not recruiting	28.08.2018
France	Not recruiting	28.08.2018
Greece	Not recruiting	28.08.2018
Hungary	Not recruiting	28.08.2018
Portugal	Not recruiting	28.08.2018
Romania	Not recruiting	28.08.2018
Spain	Not recruiting	28.08.2018

Trial locations

Investigated drugs:

Sotorasib

Sotorasib (also known as AMG 510) is a medication designed to target tumors with a specific genetic mutation called KRAS p.G12C. It works by blocking the abnormal protein that causes cancer cells to grow and spread. This medication is being studied for treating various types of advanced solid tumors, particularly non-small cell lung cancer and colorectal cancer.

Pembrolizumab is an immunotherapy medication that helps the body’s immune system detect and fight cancer cells. In this trial, it is being studied in combination with Sotorasib for treating advanced non-small cell lung cancer. Pembrolizumab works by blocking a protein that prevents the immune system from attacking cancer cells.

Investigated diseases:

Non-small cell lung cancer

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the large cells of the lungs, including squamous cells, adenocarcinomas, and large cell carcinomas. The disease develops when lung cells begin to grow uncontrollably and form tumors. It typically develops slowly and may spread to other parts of the body through the blood or lymph system.

Colorectal Cancer (CRC) – A cancer that starts in either the colon or the rectum, typically developing from small growths called polyps. The disease begins when healthy cells in the lining of the colon or rectum develop mutations and grow abnormally. It can spread through the wall of the colon or rectum and affect nearby structures.

KRAS p.G12C Mutant Advanced Solid Tumors – A specific type of cancer characterized by a mutation in the KRAS gene at position G12C, which can occur in various solid organs. This mutation causes abnormal cell growth and division. These tumors can develop in different parts of the body and are characterized by uncontrolled cell growth driven by this specific genetic change.

Trial ID:

2024-511798-31-00

Protocol code:

20170543

NCT ID:

NCT03600883

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of Sotorasib Alone and Combined with Pembrolizumab in Adult Patients with Advanced Solid Tumors Having KRAS p.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?