Actively Recruiting
Phase II Study of Axitinib Plus Nivolumab Compared to Nivolumab Alone After Induction With Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma Patients
Led by Consorzio Oncotech · Updated on 2023-05-08
118
Participants Needed
23
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Consorzio Oncotech
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates whether adding axitinib to nivolumab maintenance treatment after initial therapy with nivolumab plus ipilimumab can improve response rates in patients with metastatic renal cell carcinoma (mRCC) who have not achieved a complete response or experienced disease progression. The study is a phase II, open-label trial that aims to increase partial response rates based on prior trial results. Participants are randomly assigned to one of two groups: one group receives axitinib (5 mg twice daily orally) in addition to nivolumab (480 mg intravenously every four weeks), while the other group continues with nivolumab alone at the same dose and schedule. Treatment continues until disease progression, unacceptable side effects, patient withdrawal, or physician decision. The trial plans to enroll 118 patients to detect meaningful differences between groups. Throughout the study, participants will be closely monitored with tumor assessments and health evaluations to measure outcomes such as progression-free survival, overall survival, depth and duration of response, and treatment-related adverse events. Follow-up includes tracking health status and life status from enrollment through treatment and up to 100 days after the last dose. The study is sponsored by Consorzio Oncotech and started in April 2023, with an estimated end date in April 2027.
CONDITIONS
Brief 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 toxicity grade 2 or higher and without complete response or progressive disease
- Male or female subjects aged 18 years or older
- Available tumor tissue sample
- At least one measurable lesion as defined by RECIST version 1.1
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate organ and bone marrow function based on laboratory tests within 10 days before treatment
- Ability to understand and comply with study requirements and signed informed consent
- Sexually active fertile subjects and partners agree to use medically accepted contraception during and for 5 months after treatment
- Female subjects of childbearing potential must not be pregnant at screening
You will not qualify if you...
- Prior systemic therapy for advanced renal cell carcinoma except induction with nivolumab plus ipilimumab
- Prior adjuvant or neoadjuvant therapy
- Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
- Non-renal cell malignancy in past 2 years except certain treated skin, breast, cervical, or low-grade prostate cancers
- Recent radiation therapy or radionuclide treatment within specified timeframes before treatment
- Known brain metastases unless treated and stable for at least 3 months without symptoms or corticosteroids
- Therapeutic anticoagulation or platelet inhibitors use
- Recent serious cardiovascular events or uncontrolled hypertension
- Chronic corticosteroid or immunosuppressive treatment beyond specified exceptions
- Uncontrolled or significant intercurrent illness including cardiovascular, gastrointestinal, bleeding, pulmonary, infectious, or other serious conditions
- Major surgery within 3 months before treatment without complete wound healing
- Corrected QT interval over 500 msec within 1 month before treatment
- Vaccination within 4 weeks before first dose except inactivated vaccines
- Active autoimmune disease that may worsen with immunotherapy, except some controlled conditions
- Current use of immunosuppressive medication beyond specified exceptions
- History of substance abuse or conditions interfering with study participation
- Pregnant or lactating females
- Inability to swallow tablets or capsules
- Allergy or hypersensitivity to study treatment components
- Rare hereditary problems affecting sugar metabolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or unacceptable toxicity
Participants receive either axitinib in addition to nivolumab or nivolumab alone following prior induction treatment, continuing until disease progression, unacceptable toxicity, or decision to stop treatment.
Nivolumab administered every 4 weeks; axitinib taken orally twice daily for those in the combination arm
Duration - Up to 100 days after last treatment dose
Participants are monitored for safety and health status for up to 100 days after the last dose of study drugs.
Regular follow-up visits during this period
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
A
Axin Service
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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