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New treatment option for Metastatic Renal Cell Carcinoma
Official title Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients
ClinicalTrials.gov ID: NCT05817903
What this study is testing
What is Axitinib?
Axitinib is an investigational medicine, being studied as a potential treatment for metastatic renal cell carcinoma.
Also referred to as Inlyta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype and candidate to receive nivolumab after nivolumab plus...
- Completion of the induction of nivolumab and ipilimumab without toxicity ≥ G2 and no complete response or progressive disease.
- Male or female people 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.
You likely can't join 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...
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the start of treatment. Systemic...
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for...
See the full eligibility criteria
Who can join
- 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 people 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 people 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 people 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...
- Female people 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...
What rules you out
- 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...
- 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...
- 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 people must...
- 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...
- 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)...
- 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...
- 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...
- 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.
- Moderate to severe hepatic impairment (Child-Pugh B or C).
- Requirement for hemodialysis or peritoneal dialysis.
- History of solid organ transplantation.
- In past 6 months: deep vein thrombosis or pulmonary embolism.
- History of aneurysms and/or artery dissections
- Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 3 months before the start of treatment. Complete wound healing from major surgery must have occurred 1 month before the start of treatment...
- Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 msec within 1 month before the start of treatment (see Section 5.5.4 for Fridericia formula). Three ECGs must be performed. If the average of...
- Vaccination within 4 weeks of the first dose of nivolumab and while on trials is prohibited except for administration of inactivated vaccines.
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive...
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic...
- Has a history of substance abuse or medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Has illness or medical conditions that are unstable or could jeopardize the safety of the patient and his or her compliance in the study.
- Pregnant or lactating females.
- Inability to swallow tablets or capsules.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, Italy
- Candiolo, Italy
- Catania, Italy
- Cremona, Italy
- Florence, Italy
- Genova, Italy
- Milan, Italy
- Modena, Italy
- Monserrato, Italy
- Novara, Italy
- Padova, Italy
- Palermo, Italy
- Parma, Italy
- Pisa, Italy
- Potenza, Italy
- Pozzuoli, Italy
- Reggio Emilia, Italy
- Roma, Italy
- Romano di Lombardia, Italy
- Rozzano, Italy
+ 2 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, Italy; Candiolo, Italy; Catania, Italy; Cremona, Italy; Florence, Italy; Genova, Italy and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.