Study on Patient Preference for Subcutaneous Pembrolizumab with Hyaluronidase vs. Intravenous Pembrolizumab in Melanoma, Renal Cell Carcinoma, and Lung Cancer Patients

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What is this study about?

This clinical trial is focused on studying the preferences of patients with different types of cancer, including Melanoma, Renal Cell Carcinoma, and Non-small cell lung cancer. The study involves a treatment called Pembrolizumab, which is a type of medication used to help the immune system fight cancer. Pembrolizumab is being tested in two forms: one that is given through a vein, known as an intravenous infusion, and another that is injected under the skin, known as a subcutaneous injection. The subcutaneous form of Pembrolizumab is combined with a substance called Hyaluronidase, which helps the medication be absorbed more easily.

The purpose of this study is to understand which form of Pembrolizumab patients prefer. Participants will receive both forms of the medication during the study. They will be asked to share their preferences and satisfaction with each method of receiving the treatment. The study will also monitor any side effects that participants may experience. This information will help doctors understand which method of treatment is more comfortable and preferable for patients.

Throughout the study, participants will be asked to complete questionnaires about their experiences and preferences. The study aims to gather information on how patients feel about the convenience and comfort of each treatment method. This will help improve the way cancer treatments are given in the future, making them more patient-friendly. The study is expected to continue until 2026, providing valuable insights into patient preferences for cancer treatment administration.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, which is to evaluate the preference for two forms of the medication pembrolizumab.

The participant will be required to provide consent to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm eligibility, including a review of medical history and current health status.

The participant must have a confirmed diagnosis of melanoma, renal cell carcinoma, or non-small cell lung cancer, among other criteria.

3 treatment phase

The participant will receive pembrolizumab in two different forms: as an intravenous infusion and as a subcutaneous injection.

The intravenous form is administered as a solution for infusion, while the subcutaneous form is administered as a solution for injection.

The frequency and dosage will be determined by the study protocol and the participant’s specific condition.

4 preference evaluation

The participant will complete a questionnaire to express their preference between the two methods of administration.

The questionnaire will assess the participant’s satisfaction with each method.

5 follow-up and monitoring

The participant will be monitored for any adverse events or side effects during the study.

Regular follow-up visits will be scheduled to ensure the participant’s safety and to collect data on their experience.

6 study completion

Upon completion of the study, the participant will have a final assessment to evaluate their overall health and any long-term effects of the treatment.

The participant’s preference and satisfaction data will contribute to the study’s findings.

Who Can Join the Study?

The patient must have a confirmed diagnosis of an early stage or advanced/metastatic solid tumor, which includes:
- Melanoma: A type of skin cancer. The patient should have had surgery for Stage IIB, IIC, or III cutaneous melanoma.
- Renal Cell Carcinoma (RCC): A type of kidney cancer. The patient should have had surgery and be at intermediate-high or high risk of the cancer coming back.
- Non-small cell lung cancer (NSCLC): A type of lung cancer. The patient should have Stage IV NSCLC with a specific tumor marker called PD-L1 that is 50% or higher, and certain therapies should not be the primary treatment.
The patient should have a life expectancy of at least 3 months.
If the patient is infected with the Human Immunodeficiency Virus (HIV), their HIV should be well controlled with medication.
If the patient has hepatitis B, they should have been on antiviral therapy for at least 4 weeks and have no detectable virus in their blood before starting the study.
If the patient has a history of hepatitis C, they should have completed treatment at least 4 weeks before starting the study and have no detectable virus in their blood.
The patient should have a good general health status, as measured by a specific scale called the Eastern Cooperative Oncology Group (ECOG) performance status, with a score of 0 to 1. This means they are fully active or have some symptoms but can still carry out light work.
The study is open to both male and female patients.
The study includes patients who may be considered vulnerable.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied, which are Melanoma, Renal Cell Carcinoma, or Non-small cell lung cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specific clinical trial group being studied.
Patients who are considered part of a vulnerable population, which means they 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
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland

Other Sites

Site Name	City	Country
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Polyclinique De Limoges	Limoges	France
HIA Sainte Anne	Toulon	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cytumy Lfoz Bfgjhi	Lyon	France
Ngyupqam Ikdzyzkq Oawipcvxe Iqq Mvwob Smuanosnpklvumvbfdwafabzgdqk Ifhfckfd Bittomls	Cracow	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.11.2023
Poland	Not recruiting	15.11.2023

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab: This is a medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is being tested in two different forms: a subcutaneous form, which is injected under the skin, and an intravenous form, which is given through a vein.

Hyaluronidase: This is an enzyme that is combined with the subcutaneous form of pembrolizumab. It helps the medication be absorbed more easily when injected under the skin. This combination is being tested to see if it is preferred by patients compared to the intravenous form.

Investigated diseases:

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, the cells responsible for producing the pigment melanin. It often appears as a new mole or a change in an existing mole, with irregular borders and multiple colors. Melanoma can spread to other parts of the body if not detected early. It is more common in areas of the skin that have been exposed to the sun, but it can also occur in areas not typically exposed. The progression of melanoma can vary, with some cases remaining localized while others spread rapidly. Early detection and monitoring of skin changes are crucial in managing this disease.

Renal Cell Carcinoma – Renal cell carcinoma is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It is the most common type of kidney cancer in adults. The disease may not show symptoms in its early stages, but as it progresses, it can cause blood in the urine, back pain, and weight loss. Renal cell carcinoma can spread to other organs, including the lungs and bones. The progression of the disease can vary, with some tumors growing slowly and others more aggressively. Regular monitoring and imaging tests are often used to track the progression of the disease.

Non-Small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. NSCLC is often diagnosed at an advanced stage because early symptoms can be mild or mistaken for other conditions. The progression of NSCLC can vary, with some tumors growing slowly and others spreading quickly. Smoking is a major risk factor, but non-smokers can also develop this type of cancer.

Trial ID:

2023-506017-22-00

Protocol code:

MK-3475A-F11

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Patient Preference for Subcutaneous Pembrolizumab with Hyaluronidase vs. Intravenous Pembrolizumab in Melanoma, Renal Cell Carcinoma, and Lung Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?