Actively Recruiting
Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients
Led by Consorzio Oncotech · Updated on 2023-05-08
118
Participants Needed
23
Research Sites
206 weeks
Total Duration
On this page
Sponsors
C
Consorzio Oncotech
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced renal cell carcinoma with predominantly clear-cell subtype
- Completed induction treatment with nivolumab plus ipilimumab without severe toxicity and without complete response or progressive disease
- Male or female aged 18 years or older
- Availability of tumor tissue sample
- At least one measurable tumor lesion as defined by RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function based on specified laboratory criteria within 10 days prior to treatment
- Ability to understand and comply with study requirements and signed informed consent
- Sexually active fertile participants and partners agree to use accepted contraception during the study and for 5 months after last treatment dose
- Female participants of childbearing potential must not be pregnant at screening
You will not qualify if you...
- Prior systemic therapy for advanced renal cell carcinoma other than induction with nivolumab and ipilimumab
- Previous adjuvant or neoadjuvant therapy
- Active seizure disorders or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
- Diagnosis of non-renal cell carcinoma malignancy within 2 years except certain treated skin, breast, cervical, or prostate cancers
- Recent radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks before treatment
- Clinically relevant complications from prior radiation therapy
- Known brain metastases unless treated and stable for at least 3 months without symptoms or corticosteroids
- Therapeutic anticoagulation or platelet inhibitor use
- Cardiovascular events or conditions within past 6 months including myocardial infarction, unstable angina, heart failure, stroke, or transient ischemic attack
- Chronic corticosteroid or immunosuppressive therapy exceeding specified limits
- Uncontrolled or significant intercurrent illnesses including specific cardiovascular, gastrointestinal, bleeding, pulmonary, infectious, hepatic, or other disorders
- Major surgery within 3 months before treatment unless fully healed
- QTc interval greater than 500 msec within 1 month before treatment
- Vaccination within 4 weeks prior to first nivolumab dose except inactivated vaccines
- Active autoimmune diseases that may worsen with immunostimulatory agents except certain controlled conditions
- Current use of immunosuppressive medications except specified exceptions
- History of substance abuse or medical, psychological, or social conditions interfering with study participation
- Pregnancy or lactation
- Inability to swallow tablets or capsules
- Known allergy or hypersensitivity to study treatment components
- Rare hereditary conditions affecting metabolism of study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
ASST degli Spedali Civili di Brescia
Brescia, Italy
Not Yet Recruiting
2
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Italy
Not Yet Recruiting
3
Azienda Ospedaliera per l'emergenza Cannizzaro
Catania, Italy
Not Yet Recruiting
4
ASST di Cremona
Cremona, Italy
Not Yet Recruiting
5
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Not Yet Recruiting
6
Ospedale Policlinico San Martino
Genova, Italy
Not Yet Recruiting
7
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Italy
Not Yet Recruiting
8
Istituto Europeo di Oncologia - IEO
Milan, Italy
Not Yet Recruiting
9
A.O.U. Policlinico di Modena
Modena, Italy
Not Yet Recruiting
10
Policlinico Duilio Casula - Azienda Ospedaliero-Universitaria di Cagliari
Monserrato, Italy
Not Yet Recruiting
11
Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara, Italy
Not Yet Recruiting
12
Istituto Oncologico Veneto
Padova, Italy
Actively Recruiting
13
Casa Di Cura La Maddalena S.P.A.
Palermo, Italy
Not Yet Recruiting
14
Azienda Ospedaliera Universitaria di Parma
Parma, Italy
Not Yet Recruiting
15
Azienda Ospedalieo-Universitaria Pisana
Pisa, Italy
Not Yet Recruiting
16
San Carlo - Azienda Ospedaliera Regionale
Potenza, Italy
Not Yet Recruiting
17
Presidio Ospedaliero S. Maria Delle Grazie
Pozzuoli, Italy
Not Yet Recruiting
18
IRCCS - AUSL di Reggio Emilia
Reggio Emilia, Italy
Not Yet Recruiting
19
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Active, Not Recruiting
20
Azienda Ospedaliera San Camillo Forlanini
Romano di Lombardia, Italy
Not Yet Recruiting
21
IRCCS - Istituto Clinico Humanitas
Rozzano, Italy
Not Yet Recruiting
22
Azienda Ospedaliera Universitaria Integrata Verona - Borgo Roma
Verona, Italy
Not Yet Recruiting
23
Ospedale di Belcolle
Viterbo, Italy
Not Yet Recruiting
Research Team
R
Roberto Iacovelli, MD
CONTACT
A
Axin Service
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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