RecruitingPhase 2

Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC

France72 participantsStarted 2022-06-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years on the day of signing informed consent.
✓. Metastatic or locally advanced (inoperable) type 2 or mixed PRCC, histologically confirmed by central review: FFPE blocks (or all HES and IHC slides) with the initial histology report must be sent for central reading before confirmation of inclusion in the study.
✓. No prior systemic treatment for renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation) even in adjuvant setting.
✓. At least one measurable site of disease according to RECIST v1.1.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 evaluated within 7 days prior to the date of inclusion.
✓. In case of prior radiation therapy, discontinuation of irradiation for at least 3 weeks before first dose of study treatment, with at least 1 site kept/preserved for evaluation. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks - limited field (\<10% of the whole body)) to non-CNS disease.
✓. Adequate bone-marrow, hepatic, and renal functions within 14 days prior to the inclusion, with:
✓. Absence of significant proteinuria (\<0.5 g/24h) confirmed by urinary dipstick test. If the dipstick test is ≥ 2+, proteinuria will be quantitated on a complete 24h urine sample (\< 1 g/l of protein/24h sample)

Exclusion criteria

✕. Presence of brain metastases on Magnetic Resonance Imaging (MRI) or Computed Tomography-scan (CT-scan) performed within 28 days prior to inclusion. Patients with a history of brain metastases treated by surgery or stereotactic surgery, with normal brain MRI or CT-scan are allowed to participate.
✕. Metastases with high risk of nervous compression or bone lesion with high risk of fracture.
✕. Prior history of other malignancies other than PRCC (except for curatively treated basal cell or squamous cell carcinoma of the skin or in situ uterine cervix carcinoma) unless the subjects has been free of the disease for at least 5 years.
✕. Major surgical procedure, open biopsy, or serious none healing wound within 28 days prior to inclusion.
✕. Significant cardiovascular disease, including:
✕. Any anti-coagulation therapy except prophylactic low dose.
✕. History of auto-immune disease except thyroiditis more than 6 months ago.
✕. History of any allograft.

What they're measuring

Efficacy of axitinib + pembrolizumab versus axitinib in patients with locally advanced or metastatic type 2 papillary renal carcinoma in first-line treatment.

Timeframe: At 6 months for each patient

Trial details

NCT IDNCT05096390

SponsorCentre Leon Berard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10

Contact for this trial

Sylvie NEGRIER

0478782751 sylvie.negrier@lyon.unicancer.fr

View on ClinicalTrials.gov More Papillary Renal Cell Carcinoma Type 2 trials