Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients

Recruiting now · Phase 2

Conditions studied: Metastatic Renal Cell Carcinoma

In brief

This phase II open label trial randomized patients who completed the induction with nivolumab plus ipilimumab without complete response or progressive disease will be randomized 1:1 to receive axitinib in addition to nivolumab (Arm A) or continue with nivolumab alone (Arm B).Treatment will be continued until progression of disease, unacceptable toxicity, patient's refusal, or physician decision whichever occurred first.

Key facts

Study ID

NCT05817903

Run by

Consorzio Oncotech

People needed

118

Starts

2023-04-18

Expected to finish

2027-04-01

Last updated by the study team

2023-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype and candidate to receive nivolumab after nivolumab plus ipilimumab induction as per standard clinical practice.
• Completion of the induction of nivolumab and ipilimumab without toxicity ≥ G2 and no complete response or progressive disease.
• Male or female subjects aged ≥ 18 years
• Available tumor tissue sample.
• At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
• Eastern Cooperative Oncology Group performance status 0 or 1.
• Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria within 10 days before the start of treatment:
• Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L)
• Platelets ≥ 100,000/mm3 (≥ 100 GI/L).
• Haemoglobin ≥ 9 g/dL (≥ 90 g/L).
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3.0 × upper limit of normal.
• Total bilirubin ≤ 1.5 × the upper limit of normal. For subjects with Gilbert's disease ≤ 3 mg/dL (≤ 51.3 µmol/L).
• Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockroft-Gault.
• Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
• Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of study treatment.
• Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons.

You may not qualify if…

• Prior treatment with systemic therapy for advanced RCC with the exclusion of the induction of nivolumab and ipilimumab.
• Prior adjuvant or neoadjuvant therapy
• Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
• Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer with no plans for treatment intervention.
• Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the start of treatment. Systemic treatment with radionuclides within 6 weeks before the start of treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before the start of treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of treatment.
• Concomitant anticoagulation at therapeutic doses with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel).
• In past 6 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack.
• Chronic treatment with corticosteroids or other immunosuppressive agents (with the exception of inhaled or topical corticosteroids or corticosteroids with a daily dosage equivalent ≤ 10 mg prednisone if given for disorders other than renal cell cancer). Subjects with brain metastases requiring systemic corticosteroid are not eligible.
• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
• I. Cardiovascular disorders:
• Symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias.
• Uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
• Stroke (including TIA), myocardial infarction, or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before the start of treatment.
• II. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
• Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction.
• Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before the start of treatment. Note: Complete healing of an intra-abdominal abscess must be confirmed before the start of treatment.
• III. Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 3 months before the start of treatment.
• IV. Cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
• V. Lesions invading major pulmonary blood vessels.
• VI. Other clinically significant disorders such as:
• Active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)- related illness, or chronic hepatitis B or C infection.
• Serious non-healing wound/ulcer/bone fracture.
• Malabsorption syndrome.
• Uncompensated/symptomatic hypothyroidism.

Where it is running

• Istituto Oncologico Veneto — Padova, Italy (enrolling)
• Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS — Candiolo, Italy
• Azienda Ospedaliera per l'emergenza Cannizzaro — Catania, Italy
• ASST di Cremona — Cremona, Italy
• Azienda Ospedaliero Universitaria Careggi — Florence, Italy
• Ospedale Policlinico San Martino — Genova, Italy
• Fondazione IRCCS - Istituto Nazionale dei Tumori — Milan, Italy
• Istituto Europeo di Oncologia - IEO — Milan, Italy
• A.O.U. Policlinico di Modena — Modena, Italy
• Policlinico Duilio Casula - Azienda Ospedaliero-Universitaria di Cagliari — Monserrato, Italy
• Azienda Ospedaliero-Universitaria Maggiore della Carità — Novara, Italy
• Casa Di Cura La Maddalena S.P.A. — Palermo, Italy
• Azienda Ospedaliera Universitaria di Parma — Parma, Italy
• Azienda Ospedalieo-Universitaria Pisana — Pisa, Italy
• San Carlo - Azienda Ospedaliera Regionale — Potenza, Italy
• Presidio Ospedaliero S. Maria Delle Grazie — Pozzuoli, Italy
• IRCCS - AUSL di Reggio Emilia — Reggio Emilia, Italy
• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy
• Azienda Ospedaliera San Camillo Forlanini — Romano di Lombardia, Italy
• IRCCS - Istituto Clinico Humanitas — Rozzano, Italy
• Azienda Ospedaliera Universitaria Integrata Verona - Borgo Roma — Verona, Italy
• ASST degli Spedali Civili di Brescia — Brescia, Italy
• Ospedale di Belcolle — Viterbo, Italy

Full record on ClinicalTrials.gov

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