Study of Axitinib and Nivolumab for Patients with Metastatic Renal Cell Carcinoma Not Responding Completely to Initial Treatment

2 1 1 1

What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as metastatic renal cell carcinoma (mRCC). The study is investigating the effects of two medications, axitinib and nivolumab. Axitinib is a medication that helps to block certain proteins that promote cancer growth, while nivolumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. The trial will compare the combination of axitinib and nivolumab to nivolumab alone, following an initial treatment phase with nivolumab and another drug called ipilimumab.

The purpose of the study is to explore how effective the combination of axitinib and nivolumab is compared to nivolumab alone in treating patients with mRCC who have not had a complete response to the initial treatment. Participants will receive either the combination of axitinib and nivolumab or nivolumab alone. The study will last for a period of up to 12 months, during which the effects of the treatments will be monitored.

Throughout the study, researchers will evaluate various outcomes, such as how well the cancer responds to the treatments, the length of time patients live without the cancer getting worse, and the overall survival of the patients. Additionally, the study will assess the safety of the treatments and their impact on the quality of life of the participants. The findings from this study aim to provide valuable insights into the treatment of metastatic renal cell carcinoma.

1 induction phase

The initial phase involves treatment with nivolumab and ipilimumab. This phase is designed to prepare the body for further treatment.

During this phase, the patient receives nivolumab through an intravenous infusion. The frequency and dosage are determined by the healthcare provider based on individual needs and responses.

2 evaluation after induction

After completing the induction phase, an evaluation is conducted to assess the response to the treatment.

The evaluation checks for any side effects and determines if there is a complete response or progressive disease.

3 treatment phase with nivolumab alone or with axitinib

If the evaluation shows no complete response or progressive disease, the patient continues with nivolumab alone or in combination with axitinib.

Nivolumab is administered through intravenous infusion, while axitinib is taken orally. The dosage and frequency are tailored to the patient’s condition and response to the treatment.

4 ongoing monitoring and assessment

Throughout the trial, regular monitoring and assessments are conducted to evaluate the effectiveness and safety of the treatment.

These assessments include measuring the overall response rate, progression-free survival, and overall survival, as well as monitoring the depth and duration of response and quality of life.

5 end of trial

The trial is estimated to conclude by June 30, 2026. At the end of the trial, a final evaluation is conducted to assess the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

The patient must have a confirmed diagnosis of advanced renal cell carcinoma (RCC) with a clear-cell subtype. This means the cancer has spread beyond the kidney.
The patient should have completed treatment with nivolumab and ipilimumab without severe side effects and should not have a complete response or worsening of the disease.
The patient must be 18 years or older.
A sample of the patient’s tumor tissue must be available for testing.
The patient must have at least one tumor that can be measured according to specific medical guidelines.
The patient should have a good general health status, as determined by a specific performance scale used by doctors.
The patient must have proper functioning of organs and bone marrow, as shown by specific blood tests:

Enough white blood cells, specifically neutrophils, which help fight infection.
A sufficient number of platelets, which help with blood clotting.
Adequate levels of hemoglobin, which carries oxygen in the blood.
Liver enzymes (ALT and AST) should be within a certain range.
Bilirubin levels, which indicate liver function, should be within a certain range.
Kidney function should be within a certain range, as shown by creatinine levels or clearance.

The patient must understand the study requirements and agree to participate by signing a consent form.
If the patient is sexually active and can have children, they and their partners must agree to use reliable birth control methods during the study and for 5 months after the last treatment.
Female patients who can become pregnant must not be pregnant at the start of the study. This includes women who have had menstrual periods in the past year, unless they have had a hysterectomy.

Who Cannot Join the Study?

Patients who have a different type of cancer other than metastatic renal cell carcinoma (mRCC). This is a type of kidney cancer that has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients who have a history of severe allergic reactions to any of the study medications.
Patients who have an active infection that requires treatment.
Patients who have a history of drug or alcohol abuse that might interfere with their ability to participate in the study.

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
Azienda Usl Toscana Nord Ovest-Ospedale Civile di Livorno	Leghorn	Italy
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	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
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Ospedale Generale Provinciale Di Macerata	Macerata	Italy
Hestia Duran I Reynals	L'hospitalet De Llobregat	Spain
Azienda Sanitaria Locale Viterbo	Viterbo	Italy
ASL Napoli 2 Nord – Ospedale Santa Maria delle Grazie	Pozzuoli	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Hospital General Universitario De Castellon	Castello De La Plana	Spain
Cliniche Gavazzeni S.p.A.	Bergamo	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
Amxgkca Oprnpdyrngx Ufguypkbcylla Pxirf	Parma	Italy
Ojowthzj Sxh Dbrpls	Arezzo	Italy
Aqbcrqs Uwvx niu Sseshoexbld – Oilwfeoc db Mwpace	Mirano	Italy
Amthoah Okgowuzbbex Rseljjzoc Sjj Cqanw	Potenza	Italy
Oqciecmx Spoum Mtrwu dawla Ctjim	Ravenna	Italy
Iuklf Iopqkbke Fjmaneqbjwnbc Oqrvcyirdlex Imlvrimb Nzrwblpmt tjzohn Rltdgi Eleij	Rome	Italy
Ln Msysegpfx Sfhqey	Palermo	Italy
Aojyqec Orjiwegibjl Peu Ltzorvwixvdgizqpi Cuympxhauf	Catania	Italy
Aittczt Ofrysrpxwfr Uhlehpjohvipz Ctcejchkyael Ddhvo Sqsejq E Dvazh Sjvumln Dw Turrue	Turin	Italy
Aycyoyg Uus Ihvab Dg Rdgbng Eysnov	Reggio Emilia	Italy
Ipktkusb Cwwauw Djufornphkifgksqx	L'hospitalet De Llobregat	Spain
Fhcoajihg Prra Lj Iuwldxaifpwsr Bzujhgbto Dmz Hdmjzwss Uwasdidlpivsx Lm Pbm	Madrid	Spain
Aenhqup Szvoi Sqdzirhog Tvikdetjrfjh Dfrwp Vtqra Otjzp	Saronno	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	18.04.2023
Spain	Recruiting	18.04.2023

Trial locations

Investigated drugs:

Axitinib

Axitinib is a medication used in this trial to see if it can improve treatment outcomes when added to another drug. It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the growth of the cancer.

Nivolumab is an immunotherapy drug used in this trial. It helps the immune system recognize and attack cancer cells more effectively. It is being tested both alone and in combination with other medications to see how well it works in treating cancer.

Ipilimumab is another immunotherapy drug used during the initial phase of the trial. It works by activating the immune system to help it fight cancer cells. It is used in combination with nivolumab to see if this combination can improve treatment outcomes.

Investigated diseases:

Metastatic renal cell carcinoma

Metastatic Renal Cell Carcinoma – This is a type of kidney cancer that has spread beyond the kidney to other parts of the body. It originates in the lining of the small tubes in the kidney and can metastasize to areas such as the lungs, bones, or liver. The disease often progresses silently in its early stages, making it difficult to detect until it has advanced. As it progresses, symptoms may include blood in the urine, persistent pain in the side or back, and unexplained weight loss. The spread of cancer cells can lead to the formation of new tumors in other organs, complicating the condition. The progression and symptoms can vary significantly from person to person.

Trial ID:

2024-511397-70-00

Protocol code:

AxIn

NCT ID:

NCT05817903

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Axitinib and Nivolumab for Patients with Metastatic Renal Cell Carcinoma Not Responding Completely to Initial Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?