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Study on Safe Skin Test Concentrations for Biotherapy Allergies in Patients with Cancer Using Atezolizumab, Daratumumab, and Nivolumab

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What is this trial about?

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

This clinical trial is focused on evaluating skin tests for allergies related to certain biotherapy treatments. The diseases being studied include Chronic Lymphocytic Leukemia, AL Amyloidosis, Esophageal Squamous Cell Carcinoma, Myeloma, Cholangiocarcinoma, Hodgkin Lymphoma, Non-Small Cell Lung Carcinoma, Colorectal Adenocarcinoma with deficient mismatch repair, Small Cell Lung Carcinoma, Follicular Lymphoma, Melanoma, Hepatocellular Carcinoma, Gastric Cardia Cancer, Locally Advanced Cutaneous Squamous Cell Carcinoma, and Pleural Mesothelioma. The treatments being tested include Atezolizumab, Nivolumab, Obinutuzumab, Durvalumab, Pembrolizumab, Daratumumab, and Cemiplimab. These treatments are types of biotherapy, which use substances made from living organisms to treat diseases.

The purpose of the study is to find out the highest concentration of these biotherapy drugs that can be used in skin tests without causing irritation in patients who are not allergic. The study will involve skin tests, such as prick tests and intradermal tests, to check for any allergic reactions. Patients who have been treated with these biotherapies and have not shown any allergic reactions will be part of the study. The study will monitor for any immediate or delayed skin reactions after the tests.

Throughout the study, patients will be contacted to confirm if there are any delayed reactions, which might occur up to a week after the skin tests. If a reaction is suspected, a photograph or video consultation with an allergist may be used to confirm it. The study aims to ensure that the skin tests are safe and do not cause unnecessary irritation to patients undergoing biotherapy treatments.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details of the study.
You must be at least 18 years old and have been treated with one of the biotherapies under study, such as atezolizumab, nivolumab, obinutuzumab, durvalumab, pembrolizumab, daratumumab, or cemiplimab. You should have received at least two injections of the biotherapy without any suspected allergic side effects.
Step 2
Preparation for skin tests
If you are taking corticosteroids or H1 antihistamines, these medications should be discontinued at least one week before the skin tests. Inhaled corticosteroids are allowed.
The purpose of this step is to ensure that the medications do not interfere with the results of the skin tests.
Step 3
Skin testing
The main objective of the study is to determine the maximum non-irritant concentration of the biotherapy that can be used in skin tests. These tests include prick tests and intradermal tests.
During the skin tests, the biotherapy will be applied to your skin to check for any reactions. The goal is to find a concentration that does not cause a skin reaction in at least 9 out of 10 patients.
Step 4
Monitoring for delayed reactions
After the skin tests, you will be monitored for any delayed reactions. A delayed reaction may occur at the site of the intradermal injection 48 hours or one week after the test.
You will be contacted by phone to confirm the presence or absence of a delayed local reaction. If necessary, a photograph taken during a consultation with the allergologist or in a video consultation will confirm the reaction.

Who can join the trial?

5 criteria

Age must be 18 years or older.
Patient must be treated with one of the following biotherapies (specialized medical treatments): Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg, and must have received at least two injections without any suspected allergic side effects.
Patient must have medical care assurance or the rights to it.
Patient must provide written informed consent, which means they agree to participate in the study after understanding all the details.
If the patient is taking corticosteroids (a type of medication that reduces inflammation) or H1 antihistamines (medications that relieve allergy symptoms) by IV (intravenous) or oral route, these must be stopped at least one week before the tests. Inhaled corticosteroids are allowed.

Who cannot join the trial?

16 criteria

Patients with **Chronic lymphocytic leukemia (CLL)** cannot participate.
Patients with **AL amyloidosis** cannot participate.
Patients with **Esophageal squamous cell carcinoma** cannot participate.
Patients with **Myeloma** cannot participate.
Patients with **Cholangiocarcinoma** cannot participate.
Patients with **Hodgkin lymphoma** cannot participate.
Patients with **Non-small cell lung carcinoma** cannot participate.
Patients with **deficient mismatch repair (dMMR) colorectal adenocarcinoma** cannot participate.
Patients with **Small cell lung carcinoma** cannot participate.
Patients with **Follicular lymphoma** cannot participate.
Patients with **Melanoma** cannot participate.
Patients with **Hepatocellular carcinoma** cannot participate.
Patients with **Gastric cardia cancer** cannot participate.
Patients with **Locally advanced cutaneous squamous cell carcinoma** cannot participate.
Patients with **deficient mismatch repair (dMMR) colorectal cancer** cannot participate.
Patients with **Pleural mesothelioma** cannot participate.

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Centre Hospitalier Regional D'Angers
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Angers, France

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Investigated drugs

Biotherapy is a type of treatment that uses substances made from living organisms to treat diseases. In this clinical trial, the focus is on understanding how people who are not allergic react to biotherapy when it is used in skin tests. The goal is to find out the highest amount of biotherapy that can be used in these tests without causing irritation. This is important for patients who might be allergic to biotherapy, as it helps doctors determine if they can safely use this treatment.

What is already known about the treatment

ETCABio – This medication is administered through skin tests, specifically prick tests and intradermal tests, to evaluate potential allergies in patients undergoing biotherapy. Currently, it is being studied in clinical trials to determine the safest concentration for use in these allergy tests. The main therapeutic indications include a wide range of cancers such as chronic lymphocytic leukemia, esophageal squamous cell carcinoma, and melanoma, among others. The medication works by targeting specific pathways involved in cancer cell growth and survival, although the exact molecular mechanism is still under investigation. It falls under the pharmacological classification of biotherapy agents, which are treatments derived from biological sources to fight diseases.

Investigated diseases

Chronic lymphocytic leukemia (CLL)
Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow. It progresses slowly and is characterized by the accumulation of abnormal lymphocytes, a type of white blood cell. Over time, these abnormal cells can crowd out healthy blood cells, leading to symptoms like fatigue, infections, and swollen lymph nodes. The disease often begins with no symptoms and is usually detected during routine blood tests. As it advances, it can affect the immune system's ability to function properly.
AL amyloidosis
AL amyloidosis is a condition where abnormal protein deposits, known as amyloids, accumulate in tissues and organs. This buildup can interfere with normal function, leading to symptoms that vary depending on the organs affected. Commonly involved organs include the heart, kidneys, liver, and nerves. The disease progresses as more amyloid deposits form, potentially causing organ damage. Symptoms may include fatigue, weight loss, and swelling.
Esophageal squamous cell carcinoma
Esophageal squamous cell carcinoma is a cancer that forms in the squamous cells lining the esophagus. It typically develops in the upper and middle parts of the esophagus. The disease progresses as the cancer cells grow and invade deeper layers of the esophagus and potentially spread to nearby tissues. Symptoms often include difficulty swallowing, weight loss, and chest pain. As it advances, it can obstruct the esophagus, making it difficult to eat or drink.
Myeloma
Myeloma, also known as multiple myeloma, is a cancer of plasma cells, a type of white blood cell found in bone marrow. It progresses by causing an overproduction of abnormal plasma cells, which can crowd out healthy blood cells. This can lead to bone damage, kidney problems, and weakened immune function. Symptoms may include bone pain, fatigue, and frequent infections. The disease often affects multiple areas of the body, particularly the bones.
Cholangiocarcinoma
Cholangiocarcinoma is a cancer that forms in the bile ducts, which carry bile from the liver to the small intestine. It progresses by growing within the bile ducts and potentially spreading to nearby organs. Symptoms often include jaundice, abdominal pain, and weight loss. As the disease advances, it can block the bile ducts, leading to liver dysfunction. The cancer can be located inside or outside the liver.
Hodgkin lymphoma
Hodgkin lymphoma is a type of cancer that originates in the lymphatic system, specifically affecting lymphocytes. It progresses by causing the abnormal growth of these cells, which can spread to other parts of the body. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. The disease typically follows a predictable pattern of spreading from one group of lymph nodes to another. It is characterized by the presence of Reed-Sternberg cells.