Actively Recruiting
Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC
Led by Centre Leon Berard · Updated on 2024-01-25
72
Participants Needed
12
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)
CONDITIONS
Official Title
Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on the day of signing informed consent
- Histologically confirmed metastatic or locally advanced (inoperable) type 2 or mixed papillary renal cell carcinoma (PRCC)
- No prior systemic treatment for renal cancer including chemotherapy, immunotherapy, anti-angiogenic drugs, or investigational treatments
- At least one measurable disease site as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 evaluated within 7 days before inclusion
- If prior radiation therapy was given, it must have stopped at least 3 weeks before starting study treatment, with at least one site available for evaluation
- Adequate bone marrow, liver, and kidney function within 14 days before inclusion, including specific lab value thresholds
- No significant proteinuria (less than 0.5 g/24h) confirmed by urine tests
- Covered by medical or health insurance
- Willing and able to follow scheduled visits, treatments, lab tests, and study procedures
- For patients of childbearing potential, agreement to use effective contraception or abstain from heterosexual activity during treatment and for 4 months after last dose, or surgical sterilization
- Signed and dated informed consent form before any study procedures
You will not qualify if you...
- Presence of brain metastases on MRI or CT scan within 28 days before inclusion unless treated and currently normal imaging
- Metastases with high risk of nerve compression or bone lesions with high fracture risk
- History of other cancers except certain treated skin or cervical cancers unless disease-free for at least 5 years
- Major surgery, open biopsy, or serious non-healing wound within 28 days before inclusion
- Significant cardiovascular disease including left ventricular ejection fraction below 50%, uncontrolled high blood pressure despite treatment, recent heart attack or severe angina, serious ventricular arrhythmias, recent coronary interventions, or recent veinous thrombosis or pulmonary embolism
- Use of anticoagulation therapy beyond low-dose prophylaxis
- History of autoimmune diseases except thyroiditis over 6 months ago
- History of organ transplant
- Active infections such as HIV, hepatitis B or C
- Any active uncontrolled infection or disorder affecting study participation
- Known active tuberculosis
- Interstitial lung disease or respiratory insufficiency
- Prior pneumonitis requiring steroids or current pneumonitis
- Inability to swallow oral medications or active bowel diseases causing obstruction or chronic diarrhea
- Severe allergy to monoclonal antibodies or components of study drugs
- Recent use of immunosuppressive therapy or corticosteroids within 1 month prior to inclusion (except hydrocortisone for substitution)
- Live vaccines within 30 days before first study drug dose
- Psychological, social, or geographic conditions limiting compliance or psychiatric/substance abuse disorders
- Participation in another clinical trial except supportive care studies
- Pregnant or breastfeeding women or those planning pregnancy during the study and up to 4 months after last dose
- Under legal guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Ico - Paul Papin
Angers, France, 49055
Not Yet Recruiting
2
CHU de BESANCON
Besançon, France, 25030
Not Yet Recruiting
3
Chu Bordeaux
Bordeaux, France, 33000
Actively Recruiting
4
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
5
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
6
Institut Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
7
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
8
Ap-Hp Hôpital Europeen Georges Pompidou
Paris, France, 75004
Not Yet Recruiting
9
Ico-Rene Gauducheau
Saint-Herblain, France, 44805
Not Yet Recruiting
10
Iuct-Oncopole Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
11
Institut de Cancerologie de Lorraine - Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
12
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
S
Sylvie NEGRIER
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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