| Study name |
PAXIPEM |
| Methods |
Study type: RCT, phase II, parallel assignment
Blinding: no, open‐label
Accrual period: December 2021 ‐ December 2025 (estimated study completion date)
Countries: multicentre (11 locations in France)
Cross‐over study: no
Status: Not yet recruiting (as of October 27, 2021) |
| Participants |
Estimated enrolment: N = 72
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
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 participant 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 Any anti‐coagulation therapy except prophylactic low dose
More inclusion & exclusion criteria on CT.gov. |
| Interventions |
Experimental arm: axitinib + pembrolizumab
Control arm: axitinib monotherapy |
| Outcomes |
Primary outcome(s) :
Secondary outcome(s):
PFS (time frame: up to 24 months for each patient) OS (time frame: up to 48 months) Incidence of adverse events (time frame: up to 48 months)
Relevant to this review but not reported: TFST, QoL, number of participants who discontinued treatment due to an AE
Other outcomes (not relevant to this review): DoR, BoR |
| Starting date |
December 2021 |
| Contact information |
Sylvie Negrier |
| Notes |
Funding source: Centre Leon Berard |
