Study on Patient Preference for Nivolumab and Relatlimab Administration Methods in Melanoma Patients

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What is this study about?

This clinical trial is focused on studying Melanoma, a type of skin cancer. The study will explore different ways of administering treatments that include a combination of medications called Nivolumab and Relatlimab. These medications are given either as a solution for injection under the skin (subcutaneous) or as a solution for infusion into a vein (intravenous). The trial will also compare these methods for another medication, Nivolumab, which is used alone.

The purpose of the study is to understand which method of receiving the medication participants prefer. Participants will receive the treatments in both ways and will be asked about their preferences. The study will also monitor any side effects or unusual results from laboratory tests during the trial. This will help researchers learn more about how people feel about the different ways of receiving these treatments.

The study will involve participants who have either advanced melanoma that has spread to other parts of the body (metastatic melanoma) or melanoma that has been surgically removed (resected melanoma). The trial aims to gather information over several years to ensure a comprehensive understanding of patient preferences and the safety of the treatments.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This may include a review of your medical history, a physical examination, and laboratory tests to ensure you meet the study criteria.

3 treatment phase 1

You will receive the first treatment, which involves the administration of nivolumab and relatlimab as a fixed-dose combination. This will be given as an intravenous infusion (IV).

The dosage for this phase is 960 mg of nivolumab and 320 mg of relatlimab per vial. The frequency and duration of administration will be explained to you by the study team.

4 treatment phase 2

In the second phase, you will receive the same medications, nivolumab and relatlimab, but this time as a subcutaneous injection (SC).

The dosage remains the same, and the study team will provide details on the frequency and duration of this administration.

5 preference assessment

After completing both treatment phases, you will be asked to express your preference for either the intravenous (IV) or subcutaneous (SC) method of administration.

This feedback is crucial for understanding patient preferences in treatment delivery.

6 monitoring and follow-up

Throughout the study, you will be monitored for any side effects or changes in your health. Regular follow-up visits will be scheduled to ensure your safety and to collect necessary data.

Laboratory tests may be conducted to check for any abnormalities.

7 study completion

Upon completion of the study, a final assessment will be conducted. This may include a physical examination and laboratory tests to evaluate your overall health.

You will be informed about the study’s findings and any implications for your future treatment.

Who Can Join the Study?

Participants must be 18 years of age or older.
Both men and women can participate, but women must not be pregnant or breastfeeding.
Participants must have melanoma, which is a type of skin cancer.
Participants with metastatic melanoma (cancer that has spread to other parts of the body) should not have had previous treatment for their cancer.
Participants with resected melanoma (cancer that has been completely removed by surgery) must have had the surgery no later than 12 weeks before the start of treatment and must be confirmed free of disease.
Participants must have a low level of disability, meaning they can perform daily activities with little or no help.
Participants must have cancer that is considered advanced for metastatic melanoma or at risk for becoming advanced (intermediate) or advanced for resected melanoma.

Who Cannot Join the Study?

Patients who do not have melanoma cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital San Pedro De Alcantara	Caceres	Spain
Bioclinic S.A.	Thessaloniki	Greece
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Virgen del Rocío University Hospital	Sevilla	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Metropolitan Hospital	Athens	Greece
Ageqdzr Orirxcogrra Pfak Gdrwuydf Xzhzs	Bergamo	Italy
Iecrlb Ikdhslcz Fvkznubexhury Ootlbzbuebz	Rome	Italy
Hjqonaah Uzbgkkigrdofh Mnhzsgv Df Vzuqhfvznk	Santander	Spain
Ifjrkusz Cesdvg Dsstvyepoybnruwsc	L'hospitalet De Llobregat	Spain
Lzita Ggayvsm Hvceowzv Ok Azmygz	Athens	Greece
Irifhoam Rmbecrycy Pot Lo Seanrk Dtr Tndzws Dwra Alnlfje Itvn Stkarx	Meldola	Italy
Aobiqkc Oscicvetify Uyifylprcugpi Cteelclpwdzq Djecy Sozjxb E Dfrfg Sbaognj Dz Tsscrx	Turin	Italy
Aogtth Msdfilq Cqhvqp Saoa	Thessaloniki	Greece
Hclrkxnv Dr Ld Svham Clfq I Sjeq Pop	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	06.01.2024
Italy	Not recruiting	06.01.2024
Spain	Not recruiting	06.01.2024

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is being tested to see if patients prefer receiving it through a needle under the skin (subcutaneous) or directly into a vein (intravenous).

Relatlimab is another immune checkpoint inhibitor that is used in combination with nivolumab. It helps to further enhance the immune system’s ability to fight cancer. In this study, it is combined with nivolumab in a fixed-dose and is being tested to see if patients prefer the combination to be given under the skin or into a vein.

Investigated diseases:

Malignant melanoma

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It often appears as a new mole or a change in an existing mole, typically with irregular borders and multiple colors. As melanoma progresses, it can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease can develop on any skin surface but is more common in areas exposed to the sun, such as the back, legs, arms, and face. Melanoma can also occur in the eyes and, rarely, in internal organs. Early detection is crucial, as the disease can be more effectively managed before it spreads extensively.

Trial ID:

2023-504515-33-00

Protocol code:

CA224-1044

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Patient Preference for Nivolumab and Relatlimab Administration Methods in Melanoma Patients

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