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Study on the Safety of Avelumab for Patients with Solid Tumors Continuing Treatment

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What is this study about?

This clinical trial is focused on studying the effects of the medication avelumab, also known by its code name MSB0010718C, in patients with solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. Avelumab is a type of medication called an antibody, which is designed to help the immune system fight cancer cells. It is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein.

The purpose of this study is to monitor the safety and tolerability of avelumab in participants who are continuing their treatment from previous studies. Participants in this trial will continue to receive avelumab under the same treatment regimen as they did in their original study. The study will collect long-term data to better understand how patients respond to the treatment over time. This includes monitoring any side effects or reactions that may occur during the treatment.

Throughout the study, participants will be observed for any treatment-related side effects, including both serious and non-serious events. The study will also track overall survival, which refers to the length of time from the start of the original study until death from any cause, and progression-free survival, which measures the time during which the disease does not get worse. The study aims to provide valuable information on the long-term effects of avelumab in treating solid tumors.

1 joining the study

Upon joining the study, participants must provide signed informed consent. This consent confirms understanding and agreement to comply with the study’s requirements and restrictions.

2 treatment continuation

Participants will continue receiving the medication avelumab, which is administered as a solution for infusion. This means the medication is given directly into a vein through an intravenous (IV) line.

The dosage and frequency of avelumab administration will remain the same as in the previous study the participant was enrolled in.

3 monitoring and follow-up

Participants will be monitored for any side effects or reactions to the treatment. This includes tracking any non-serious and serious adverse events, as well as any immune-related or infusion-related reactions.

Regular follow-up visits will be scheduled to assess the participant’s health and response to the treatment.

4 safety and tolerability assessment

The main objective of the study is to monitor the safety and tolerability of avelumab in participants with solid tumors. This involves evaluating how well participants tolerate the treatment over time.

5 study duration

The study is expected to continue until October 31, 2025. Participants will remain in the study for the duration of their treatment or until they choose to withdraw.

Who Can Join the Study?

  • Participants must be 18 years of age or older at the time of signing the consent form.
  • Participants must be currently enrolled in an avelumab clinical study sponsored by EMD Serono Research & Development Institute, Inc., Merck KGaA, or Merck Serono Co., Ltd (Japan).
  • Participants must be currently enrolled in an avelumab parent study where the main analysis is completed and must meet one of the following conditions:
    • Currently receiving active avelumab treatment in any parent study, regardless of the condition being treated.
    • In long-term survival follow-up after treatment for Non-Small Cell Lung Cancer (NSCLC), Renal Cell Carcinoma (RCC), Urothelial Carcinoma (UC), or ovarian cancer.
    • Experienced complete response (CR) in the parent study and stopped avelumab treatment according to the parent study protocol.
  • Participants can be male or female. Those on active treatment must agree to use highly effective contraception if there is a risk of pregnancy. This means using methods with a failure rate of less than 1% per year. Contraception must be used 28 days before starting the study, during the study, and for at least 60 days after stopping the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating, the doctor should be informed immediately.
  • Participants must be able to give signed informed consent, which means they understand and agree to follow the study’s requirements and restrictions.

Who Cannot Join the Study?

  • Participants cannot join if they have any medical conditions other than solid tumors.
  • Participants must be continuing treatment with avelumab as part of the same treatment plan from a previous study.
  • Participants must not be part of a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Consorci Sanitari Del Maresme Mataró Spain
Radiotherapy Center Cluj S.R.L. Floresti Romania
Mbal Za Zhensko Zdrave Nadezhda OOD Sofia Bulgaria
Institutul Regional De Oncologie Iasi Iasi Romania
Oncomed S.R.L. Timisoara Romania
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Bvsrmask Uhwumjlbdf Hzmysvol Cxiwwa Besançon France
Ngjvfcii Ietntzge Oywbwwiod Ikl Mdnit Sjsqrcqttfogmwqwuztcogniamgi Insclbqz Buzkuyyx Cracow Poland
Hqrbwtgv Vbja dygxwxhw Barcelona Spain

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
21.03.2019
France France
Not recruiting
21.03.2019
Hungary Hungary
Not recruiting
21.03.2019
Italy Italy
Not recruiting
21.03.2019
Poland Poland
Not recruiting
21.03.2019
Romania Romania
Not recruiting
21.03.2019
Spain Spain
Not recruiting
21.03.2019

Trial locations

Investigated drugs:

Avelumab is a type of medication used in cancer treatment. It is an immunotherapy drug, which means it helps your immune system fight cancer cells. Avelumab works by blocking a specific protein that cancer cells use to hide from the immune system. By blocking this protein, avelumab allows your immune system to recognize and attack the cancer cells more effectively. This medication is used for treating various types of solid tumors, and in this study, it is being monitored for its long-term safety and how well patients can tolerate it.

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, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, solid tumors can invade nearby tissues and organs, potentially disrupting their normal function. They may also spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The growth rate and behavior of solid tumors can vary widely depending on their type and location.

Trial ID:
2024-514274-46-00
Protocol code:
MS100070_0176
NCT ID:
NCT03815643
Trial Phase:
Therapeutic confirmatory (Phase III)

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