REGN10597 Alone or with Cemiplimab in Adults with Advanced Solid Tumours, Melanoma, or Clear-Cell Renal-Cell Carcinoma

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What is this study about?

This study is looking at melanoma, clear-cell renal-cell carcinoma, and other advanced solid tumors, which are cancers that have spread and are harder to treat. The medicines being studied are REGN10597, also called an anti PD-1-IL2RA-IL2 fusion protein, and cemiplimab (LIBTAYO), given through a vein. The purpose of the study is to find out how safe these medicines are and how well they may work against these cancers.

The study is done in two parts. In the first part, different doses of REGN10597 are tested alone and with cemiplimab to see how people tolerate the treatment. In the second part, more people receive the study treatment to learn more about its effect on the cancer. Participants are followed over time while the medicines are given and after treatment ends.

1 study treatment begins

After joining the study, you receive REGN10597 by intravenous infusion, which means the medicine is given through a vein.

The study also includes cemiplimab, given by intravenous infusion in the study arm that uses the combination treatment.

The exact dose and schedule for REGN10597 and cemiplimab are not specified in the source data.

The treatment is given during the study period, which is planned to run from 30 june 2026 to 28 april 2030.

2 safety monitoring during treatment

During treatment, you are monitored for side effects, including serious side effects and side effects that may lead to stopping treatment or death.

Your blood tests may be checked for laboratory abnormalities, which means results that are outside the normal range.

The study records whether any dose-limiting toxicities occur. This means side effects that are severe enough to limit the amount of medicine that can be given.

3 tumor assessment during the study

Your cancer is assessed to see whether the tumors shrink, stay the same, or grow.

The study uses RECIST 1.1, which is a standard method for measuring how a tumor changes on scans.

The study looks at objective response rate, best overall response, duration of response, disease control rate, time to response, and progression-free survival.

Progression-free survival means the length of time during which the cancer does not get worse.

4 blood testing for the study medicine

Blood samples are taken to measure the amount of REGN10597 in your blood.

The study also checks for anti-drug antibodies, which are antibodies your body may make against the study medicine.

These blood tests are used to see how the medicine behaves in the body over time.

5 study follow-up and treatment changes

If you have side effects that are serious or if the study medicine is not tolerated, treatment may be stopped.

The study records whether treatment is discontinued because of side effects.

The study also records whether death occurs during treatment or follow-up.

Who Can Join the Study?

Be an adult, meaning 18 years of age or older.
For the dose escalation part of the study, have a solid cancer that has been confirmed by a tissue sample or cell sample. Histologically confirmed means the diagnosis was made by looking at tissue under a microscope. Cytologically confirmed means the diagnosis was made by looking at cells under a microscope.
For the dose escalation part of the study, the cancer must be locally advanced or metastatic. Locally advanced means the cancer has grown beyond where it started but not to distant parts of the body. Metastatic means the cancer has spread to other parts of the body.
For the dose escalation part of the study, the cancer must have gotten worse after standard treatment. Standard treatment means the usual approved treatment used for that cancer.
For the dose escalation part of the study, if an archival tissue sample is available, it must be submitted. Archival tissue means a stored tissue sample taken in the past.
For the dose expansion part of the study, have melanoma or clear-cell renal-cell carcinoma (ccRCC) confirmed by tissue or cell testing. Melanoma is a cancer of the cells that make skin pigment. Clear-cell renal-cell carcinoma is a type of kidney cancer.
For the dose expansion part of the study, meet the protocol-defined criteria for melanoma or ccRCC. Protocol-defined criteria means specific rules written in the study plan.
For the dose expansion part of the study, provide a fresh pretreatment biopsy during screening. A biopsy is a small sample of tissue taken from the body. Pretreatment means it is taken before study treatment starts. Fresh means a new sample collected for this study.
For the dose expansion part of the study, be willing to provide an additional exploratory biopsy at other time points if required. Exploratory means it is used to help researchers learn more about the treatment and cancer.
Meet all other inclusion criteria listed in the study protocol.

Who Cannot Join the Study?

Any previous treatment with interleukin 2 (IL-2), IL-15, or IL-7 if it was given by itself and not together with adoptive cell therapy (a treatment that uses a patient’s own immune cells).
Previous treatment with anti-PD-1 or anti-PD-L1 therapy, or with an approved systemic therapy (treatment that works throughout the whole body) or any previous systemic non-immunomodulatory biologic therapy (a biologic medicine that does not change the immune system) within the last 4 weeks, if this is defined in the study rules.
Received radiation therapy (high-energy treatment such as X-rays) or major surgery within 14 days before the first dose of the study drug, or has not recovered from side effects from those treatments.
Had previous anti-cancer immunotherapy (treatment that helps the immune system fight cancer) within 4 weeks before the study treatment, or stopped a previous anti-cancer immunotherapy because of severe side effects of grade 3 or 4 (serious or very serious) toxicity.
Has ongoing immune-related side effects before starting the study treatment.
Has a known allergy or hypersensitivity (strong allergic reaction) to any part of the study drugs.
Needs ongoing or continuous corticosteroid treatment (steroid medicine) of more than 10 mg of prednisone per day, or an equivalent anti-inflammatory dose, within 1 to 2 weeks before the first study dose.
Has an ongoing or recent autoimmune disease within the last 5 years, or any other condition that needed treatment with systemic immunosuppressive treatment (medicine that lowers the immune system).
Any other exclusion rule listed in the study plan also applies.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ucnmakbwyv Myfdzrv Ctxcwt Hokzuziufgzgstrma	Hamburg	Germany
Uczbdawuissywkfdqlysu Epllf Aox	Essen	Germany
Hhgyffwp Vsdj dghgwtej	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	30.06.2026
Germany	Not yet recruiting	30.06.2026
Italy	Not yet recruiting	30.06.2026
Spain	Not yet recruiting	30.06.2026

Trial locations

Investigated drugs:

Cemiplimab

cemiplimab is an immunotherapy given through a vein. It helps the body’s immune system recognize and attack cancer cells more effectively. In this trial, it is being studied by itself and also together with another treatment to see how safe it is and whether it may help control advanced solid tumors.

REGN10597 is an experimental immunotherapy given through a vein. It is designed to help the immune system fight cancer by acting on immune signals that can boost the body’s ability to attack tumor cells. In this study, researchers are testing it alone and in combination with cemiplimab to learn more about its safety and early signs of anti-cancer activity.

Investigated diseases:

Melanoma – Melanoma is a cancer that begins in pigment-producing cells, usually in the skin. It often starts as a changing mole or a new dark spot and can spread into nearby skin and deeper tissues over time. As it progresses, it may form larger skin lesions and spread to other parts of the body. Advanced Solid Tumours – Advanced solid tumours are cancers made up of solid masses in organs or tissues that have grown beyond their original site. They usually progress by increasing in size, invading nearby structures, and spreading to distant areas. This term describes later-stage solid cancers from different body sites rather than one specific disease. Clear-Cell Renal-Cell Carcinoma – Clear-cell renal-cell carcinoma is a type of kidney cancer that starts in the lining of small tubes in the kidney. It often grows as a mass in the kidney and may gradually spread into nearby tissue, blood vessels, or other organs. Over time, it can become more widespread and cause larger tumour deposits in different parts of the body.

Trial ID:

2025-523399-22-00

Protocol code:

R10597-ONC-22114

NCT ID:

NCT06413680

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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REGN10597 Alone or with Cemiplimab in Adults with Advanced Solid Tumours, Melanoma, or Clear-Cell Renal-Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?