Study on Pembrolizumab for Patients with Resectable Metastases from Kidney Cancer

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as oligometastatic renal cell carcinoma. This condition involves a limited number of cancerous growths that have spread from the kidney to other parts of the body. The study is investigating the effectiveness of a treatment called pembrolizumab, which is also known by its brand name, KEYTRUDA. Pembrolizumab is a medication given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to see if pembrolizumab can help delay the progression of the cancer in patients who are candidates for surgery or radiation therapy to remove or treat these metastases.

Participants in the study will receive pembrolizumab, and some may receive a placebo. The study will compare the outcomes of those who receive pembrolizumab with those who do not, to determine if the medication is effective in extending the time before the cancer progresses. The study will also look at how long patients live after treatment and monitor any side effects that may occur. The trial is expected to continue for several years to gather enough information to make these assessments.

Throughout the study, patients will undergo regular check-ups and imaging tests to monitor the status of their cancer. These tests will help doctors understand how the cancer is responding to the treatment. The ultimate goal is to find out if pembrolizumab can improve the quality of life and survival for patients with this type of kidney cancer.

1 enrollment

Participants must be at least 18 years old with a confirmed diagnosis of clear cell renal cell carcinoma.

Participants should have undergone a partial or complete nephrectomy with no cancer cells at the edges of the removed tissue.

Participants must have a limited number of metastases that can be treated with surgery or radiotherapy.

2 treatment initiation

The treatment involves the administration of pembrolizumab, a medication given through an intravenous infusion.

The specific product used is KEYTRUDA 25 mg/mL concentrate for solution for infusion.

3 treatment schedule

Pembrolizumab is administered at regular intervals as determined by the study protocol.

The duration of the treatment period is aligned with the study’s objectives to evaluate the delay in tumor progression.

4 monitoring and assessments

Participants will undergo regular monitoring to assess the response to treatment.

Assessments include imaging studies to detect any progression of kidney cancer.

5 completion and follow-up

The study aims to evaluate the time until any cancer progression or the appearance of new metastases.

Participants will be followed up to assess overall survival and any side effects experienced during the trial.

Who Can Join the Study?

Participants must be at least 18 years old and have a confirmed diagnosis of clear cell renal cell carcinoma. This is a type of kidney cancer.
Participants should have had a partial nephrectomy or radical complete nephrectomy with no cancer cells left at the edges of the removed tissue. These are surgeries to remove part or all of a kidney.
Participants must have oligo-metastatic disease that can be treated with local radiotherapy or surgery. This means having a small number of cancer spread areas that can be treated.
New metastases should have appeared within 5 years after the primary tumor or previous metastases were removed.
Participants can have a maximum of 3 metastases in the same or different locations, except for bone metastases, which cannot exceed 2 if they are the only disease site, or 1 if there are multiple sites.
Each metastasis should be less than 3 cm in size, and the total size of all tumors should be less than 5 cm.
Participants should not have received any previous systemic therapy for renal cell carcinoma. This means no treatments that affect the whole body, like chemotherapy.
Participants must have an ECOG performance status of 0 to 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Participants or their legal representatives must provide written consent to participate in the study.
Participants must provide a sample of tumor tissue, either from a previous surgery or a new biopsy. A biopsy is a procedure to remove a small piece of tissue for testing.
Female participants must not be pregnant or breastfeeding and must agree to use birth control if they are of childbearing potential.
Participants must have adequate organ function, meaning their organs are working well enough to participate in the study.

Who Cannot Join the Study?

Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period.
Patients who are currently participating in another clinical trial.
Patients who have an allergy to the study medication or similar drugs.
Patients who have an active infection that requires treatment.
Patients who have a history of certain heart problems.
Patients who have a history of certain lung problems.
Patients who have a history of certain liver problems.
Patients who have a history of certain kidney problems.
Patients who have a history of certain immune system problems.
Patients who have a history of certain mental health problems.
Patients who have received certain treatments for cancer recently.
Patients who have had a major surgery recently.
Patients who have received a live vaccine recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Ospedaliera Di Perugia	Perugia	Italy
Ospedale Generale Provinciale Di Macerata	Macerata	Italy
Azienda Sanitaria Locale Napoli 2 Nord	Frattamaggiore	Italy
Azienda Sanitaria Locale Viterbo	Viterbo	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Azienda Sanitaria Locale Di Salerno	Battipaglia	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Aaswrkz Olznrzdgjig Uwumtjccpokyc Pkxfq	Parma	Italy
Ifkbzh Iinrqyuc Firfptopfbtxg Oxrakmjdyrs	Rome	Italy
Ll Mrpbzdxih Sfphqt	Palermo	Italy
Axbqvgy Uke Tjozpsp ncse ocisg	Leghorn	Italy
Aldcbrb Oozfzxrqpzf Pdk Lywyisbtzijdramxx Cittaitsvu	Catania	Italy
Axfqffx Ovgtpulkhin Uqdelihulogsv Cqpchvrzcgpx Deuhf Sbbzzy E Draqi Shjcjiw Dj Twwmwb	Turin	Italy
Awyzlbf Umn Ihidc Dv Rnhpjf Ekjdgl	Reggio Emilia	Italy
Amnatgp Uztnq Suigkmbbe Lddgza Dd Bfkgeud	Bologna	Italy
Aroqqjq Oxlswabyudw Puno Gluzdwzu Xfjhh	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	14.03.2023

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab is a medication used in this clinical trial to help delay the progression of kidney cancer that has spread to other parts of the body. It works by helping the immune system recognize and attack cancer cells more effectively. This treatment is being tested in patients who have a small number of metastases and are candidates for surgery or radiation therapy to remove or treat these metastases.

Investigated diseases:

Metastatic renal cell carcinoma

Oligometastatic Renal Cell Carcinoma – This is a type of kidney cancer that has spread to a limited number of other parts of the body. It is characterized by the presence of a few metastatic sites, typically fewer than five. The disease progresses as cancer cells from the kidney travel through the bloodstream or lymphatic system to other organs. These metastases can grow and potentially cause symptoms depending on their location. The progression of the disease can vary, with some patients experiencing slow growth of metastases. Understanding the behavior of these limited metastases is crucial for determining appropriate treatment strategies.

Trial ID:

2024-512180-31-00

Protocol code:

PE-PE

NCT ID:

NCT05578664

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pembrolizumab for Patients with Resectable Metastases from Kidney Cancer

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