Study on Reduced Dose Intensity of Pembrolizumab and Drug Combination for Patients with Advanced or Metastatic Cancer Responding to Standard Immunotherapy

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What is this study about?

This clinical trial is focused on studying various types of cancer, including lung cancer, kidney cancer, head and neck cancer, bladder cancer, triple-negative breast cancer, Merkel cell cancer, melanoma, liver cancer, colorectal cancer with a specific genetic feature called microsatellite instability, esophageal cancer, endometrial cancer, cervical cancer, stomach cancer, and certain types of skin cancer. The study involves patients whose cancer is either locally advanced or has spread to other parts of the body, and who have shown a positive response after six months of standard treatment with immunotherapy. Immunotherapy is a type of treatment that helps the immune system fight cancer.

The purpose of this study is to compare the effects of continuing standard immunotherapy with a reduced dose of the same treatment. The medications being studied include Pembrolizumab, Durvalumab, Avelumab, Nivolumab, Dostarlimab, Atezolizumab, and Cemiplimab. These medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. Some patients will receive the standard dose of these medications, while others will receive a reduced dose every three months.

The study will last for up to three years, during which time patients will continue to receive their assigned treatment. The main goal is to see if the reduced dose is as effective as the standard dose in keeping the cancer from getting worse. Patients will have regular check-ups and assessments to monitor their health and the progress of their cancer. The study will also look at other factors, such as the quality of life and any side effects experienced by the patients. This research aims to find the best way to use immunotherapy to treat cancer effectively while minimizing side effects.

1 joining the study

Upon joining the study, the patient must have signed a written informed consent form. This is a document that confirms understanding and agreement to participate in the trial.

The patient must meet specific criteria, such as being at least 18 years old, having a confirmed diagnosis of certain types of cancer, and being in partial or complete response after 6 months of standard immunotherapy.

2 randomization

The patient will be randomly assigned to one of two groups: one receiving standard immunotherapy and the other receiving a reduced dose intensity of the same immunotherapy.

This process ensures that the study results are unbiased and reliable.

3 treatment administration

The patient will receive immunotherapy through intravenous use. The specific medication could be one of several options, such as pembrolizumab, durvalumab, or nivolumab, among others.

The frequency of administration will depend on the group assignment: standard administration or every three months for the reduced dose group.

4 scheduled visits and assessments

The patient will attend regular visits to monitor health and response to treatment. These visits will include examinations and possibly imaging tests to assess the cancer’s status.

The patient’s quality of life and any side effects will be evaluated using questionnaires and clinical assessments.

5 follow-up

The patient will continue to be monitored for progression-free survival, which is the time from randomization until the cancer progresses or the patient passes away.

Additional follow-up assessments will occur at various intervals, such as 12 and 24 months post-randomization, to evaluate overall survival and other health outcomes.

Who Can Join the Study?

  • Patients must have signed a written informed consent form before any trial-specific procedures.
  • Patients must show evidence of being post-menopausal or have a negative pregnancy test if they are premenopausal.
  • Both sexually active women who can have children and men (and their female partners) must agree to use a reliable method of birth control during the study and after completing treatment.
  • Patients must be willing and able to follow the study rules, including attending treatment sessions, scheduled visits, and examinations.
  • Patients must be part of a Social Security System.
  • Patients must be 18 years old or older.
  • Patients must have a type of cancer that is either metastatic (spread to other parts of the body) or locally advanced (grown too much to be treated locally). This includes specific types of cancer like lung cancer, kidney cancer, head and neck cancer, and others listed.
  • Patients must be in partial or complete response after 6 months of standard immunotherapy treatment. For melanoma, only those in partial response are eligible. This response must be confirmed by a local radiological assessment.
  • Patients must be eligible to continue the same standard immunotherapy treatment.
  • Patients must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Patients with brain metastases (cancer spread to the brain) are allowed if they are stable, meaning they have been treated and show no signs of getting worse.
  • Patients who have previously received immunotherapy combined with chemotherapy are allowed.
  • Patients treated with specific combinations of drugs like TKI-IO, pemetrexed-IO, or bevacizumab-IO are allowed.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with a specific type of cancer, such as lung cancer, kidney cancer, head and neck cancer, bladder cancer, a certain type of breast cancer, Merkel cell cancer, skin cancer, liver cancer, colon cancer with a specific genetic feature, esophageal cancer, uterine cancer, cervical cancer, stomach cancer, or certain types of skin cancer.
  • Patients who have not shown a partial or complete response to treatment after 6 months of standard immunotherapy. Immunotherapy is a type of treatment that helps your immune system fight cancer.
  • Patients with melanoma who have not shown a partial response to treatment. Melanoma is a type of skin cancer.
  • Patients who have been treated with a combination of certain drugs and have not shown a response. These drugs include ipilimumab, pemetrexed, bevacizumab, or Tyrosine Kinase Inhibitors (TKI). These are specific types of cancer treatments.

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
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Centre Jean Perrin Clermont Ferrand France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Polyclinique De Limoges Limoges France
HIA Sainte Anne Toulon France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier De Boulogne Sur Mer Boulogne sur Mer France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Institut Sainte Catherine Avignon France
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Cjbrwk Luur Bmhilj Lyon France
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Ctropb Hebigokvhsq Riumooet Ugonceuxourqw Ds Tkuap Tours France
Csc Cuekl Rjsezetzfzd Lyon France
Izwouwul Ppnolgzucveawfy Claspy Ctukvj Marseille France
Cicipk Ooxte Loyqltv Lille France
Huwehizk Ubnolerosihxds Sgejdiyamc &ywenbj Hyakjsy dt Hrbtweefjjn STRASBOURG, Alsace France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
08.03.2022

Trial locations

Checkpoint Inhibitors are a type of immunotherapy used in this trial. They work by helping the immune system recognize and attack cancer cells more effectively. These medications block certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. This blocking action helps the immune system destroy cancer cells. In this trial, checkpoint inhibitors are used as a standard treatment for patients with locally advanced or metastatic cancer.

Reduced Dose Intensity of Checkpoint Inhibitors is another approach being tested in this trial. After patients have been on standard checkpoint inhibitors for six months and have shown a response, the trial explores whether a lower dose of these inhibitors can maintain the same effectiveness in controlling the cancer. This approach aims to reduce potential side effects while still providing the benefits of immunotherapy.

Lung Cancer – A disease characterized by uncontrolled cell growth in the tissues of the lung. It often begins in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. As it progresses, it can spread to other parts of the body, including the lymph nodes and brain. Symptoms may include persistent cough, chest pain, and shortness of breath. The disease can be classified into small cell lung cancer and non-small cell lung cancer, each with different growth patterns.

Renal Cell Carcinoma – A type of kidney cancer that originates in the lining of the proximal convoluted tubule. It is the most common type of kidney cancer in adults. The disease may initially present with symptoms such as blood in the urine, flank pain, and a mass in the abdomen. As it progresses, it can spread to nearby tissues and distant organs. The cancer cells can grow into a large mass and may invade the renal vein or spread to the lungs and bones.

Head and Neck Cancer – A group of cancers that originate in the squamous cells lining the moist surfaces inside the head and neck. These cancers can affect areas such as the mouth, throat, and larynx. Symptoms may include a lump or sore that does not heal, a persistent sore throat, and difficulty swallowing. As the disease progresses, it can spread to lymph nodes and other parts of the body. Risk factors include tobacco use, alcohol consumption, and human papillomavirus (HPV) infection.

Urothelial Carcinoma – A cancer that occurs in the urothelial cells lining the bladder, ureters, and other parts of the urinary tract. It is the most common type of bladder cancer. Symptoms may include blood in the urine, frequent urination, and pain during urination. As it progresses, it can invade the bladder wall and spread to nearby lymph nodes and organs. The disease is often linked to smoking and exposure to certain industrial chemicals.

Triple Negative Breast Cancer – A subtype of breast cancer that lacks estrogen, progesterone, and HER2 receptors. It tends to be more aggressive and has fewer treatment options compared to other breast cancer types. Symptoms may include a lump in the breast, changes in breast shape, and skin dimpling. The cancer can spread to other parts of the body, including the lymph nodes and lungs. It is more common in younger women and those with a BRCA1 gene mutation.

Merkel Cell Carcinoma – A rare and aggressive skin cancer that originates in the Merkel cells located in the skin. It often appears as a painless, fast-growing nodule on sun-exposed areas of the skin. The disease can quickly spread to nearby lymph nodes and distant organs. Risk factors include excessive sun exposure, a weakened immune system, and infection with the Merkel cell polyomavirus. Early detection is crucial due to its rapid progression.

Melanoma – A type of skin cancer that develops from the pigment-producing melanocytes. It is known for its ability to spread to other parts of the body if not detected early. Symptoms include changes in the size, shape, or color of a mole or the appearance of a new mole. The disease can invade nearby tissues and metastasize to organs such as the lungs and brain. Risk factors include excessive sun exposure and genetic predisposition.

Hepatocellular Carcinoma – The most common type of primary liver cancer, originating in the hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis infection. Symptoms may include abdominal pain, weight loss, and jaundice. As it progresses, the cancer can invade blood vessels and spread to other parts of the body. Early stages may not present noticeable symptoms, making regular monitoring important for at-risk individuals.

Colorectal Carcinoma with Microsatellite Instability – A form of colorectal cancer characterized by genetic hypermutability due to defects in the DNA mismatch repair system. It often presents with symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. The disease can spread to nearby lymph nodes and distant organs like the liver and lungs. Microsatellite instability is associated with a better response to certain immunotherapies. It is often linked to hereditary conditions like Lynch syndrome.

Esophageal Squamous Cell Carcinoma – A type of esophageal cancer that begins in the flat, thin cells lining the esophagus. It is more common in the upper and middle parts of the esophagus. Symptoms may include difficulty swallowing, chest pain, and weight loss. As it progresses, the cancer can invade deeper layers of the esophagus and spread to nearby lymph nodes and organs. Risk factors include smoking, heavy alcohol consumption, and dietary habits.

Endometrial Carcinoma – A cancer that originates in the lining of the uterus, known as the endometrium. It is the most common type of uterine cancer. Symptoms often include abnormal vaginal bleeding, pelvic pain, and weight loss. The disease can spread to the myometrium, cervix, and distant organs if not detected early. Risk factors include obesity, hormone replacement therapy, and a history of polycystic ovary syndrome.

Cervical Cancer – A cancer that occurs in the cells of the cervix, the lower part of the uterus that connects to the vagina. It is often caused by persistent infection with high-risk types of human papillomavirus (HPV). Symptoms may include abnormal vaginal bleeding, pelvic pain, and pain during intercourse. As it progresses, the cancer can invade nearby tissues and spread to distant organs. Regular screening and HPV vaccination can help prevent the disease.

Gastric/Gastro-Esophageal Junction/Esophageal Adenocarcinoma – A type of cancer that forms in the glandular cells of the stomach or the junction where the stomach meets the esophagus. Symptoms may include difficulty swallowing, weight loss, and abdominal pain. The disease can spread to nearby lymph nodes and distant organs such as the liver and lungs. Risk factors include chronic gastroesophageal reflux disease (GERD), obesity, and smoking. Early detection is challenging due to nonspecific symptoms.

Basal Cell Carcinoma – The most common type of skin cancer, originating in the basal cells of the epidermis. It often appears as a small, shiny bump or a pink growth on sun-exposed areas of the skin. The cancer grows slowly and rarely spreads to other parts of the body. However, it can cause significant local damage if left untreated. Risk factors include prolonged sun exposure and fair skin.

Squamous Cell Carcinoma of the Skin – A common form of skin cancer that begins in the squamous cells of the epidermis. It typically appears as a red, scaly patch or a sore that may crust or bleed. The cancer can grow into deeper layers of the skin and spread to other parts of the body. Risk factors include excessive sun exposure, a history of sunburns, and a weakened immune system. Early detection and treatment are important to prevent complications.

Trial ID:
2024-513707-14-00
Protocol code:
UC-IMM-2101
NCT ID:
NCT05078047
Trial Phase:
Therapeutic confirmatory (Phase III)

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