RecruitingPhase 2NCT05096390

Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC

Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)


Sponsor

Centre Leon Berard

Enrollment

72 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug pembrolizumab to axitinib (a targeted anti-cancer drug) can improve treatment outcomes for people with advanced papillary renal cell carcinoma (type 2 or mixed PRCC) — a less common type of kidney cancer — compared to axitinib alone. **You may be eligible if...** - You have been diagnosed with metastatic or locally advanced type 2 or mixed papillary renal cell carcinoma, confirmed by central laboratory review - You have not had any prior systemic treatment for kidney cancer - Your cancer has at least one measurable tumor on scans - You are 18 or older in reasonably good physical health (ECOG ≤ 1) - Your blood, kidney, and liver function are within acceptable ranges **You may NOT be eligible if...** - You have received any prior systemic treatment for this kidney cancer - You have active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have active brain metastases - You have significant heart or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAxitinib Oral Tablet [Inlyta]

Axitinib 5 up to 10mg twice a day

DRUGPembrolizumab Injection [Keytruda]

Pembrolizumab intravenously over 30 min minutes at 200 mg every 3 weeks


Locations(12)

Ico - Paul Papin

Angers, France

CHU de BESANCON

Besançon, France

Chu Bordeaux

Bordeaux, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Leon Berard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

Centre Antoine Lacassagne

Nice, France

Ap-Hp Hôpital Europeen Georges Pompidou

Paris, France

Ico-Rene Gauducheau

Saint-Herblain, France

Iuct-Oncopole Institut Claudius Regaud

Toulouse, France

Institut de Cancerologie de Lorraine - Alexis Vautrin

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT05096390