Study of Lenvatinib Plus Pembrolizumab in IO Refractory mRCC Patients With Brain Metastases (NCT07011849) | Clinical Trial Compass
WithdrawnPhase 2
Study of Lenvatinib Plus Pembrolizumab in IO Refractory mRCC Patients With Brain Metastases
Stopped: 0 participants
0Started 2025-06-04
Plain-language summary
This is a multi-center, open-label phase II study evaluating the efficacy and safety of pembrolizumab in combination with lenvatinib in patients with renal cell carcinoma (RCC) and brain metastasis who were previously treated with immune checkpoint blockade.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male/female participants .18 years of age on the day of signing informed consent withhistologically confirmed diagnosis of RCC, irrespective of histologic will be enrolled in this study. Because no dosing or adverse event data are currently available on the use of lenvatinib in combination with pembrolizumab in patients \<18 years of age, children are excluded from this study.
✓. Criteria for brain metastasis:
✓. Has at least 1 measurable brain metastasis with no prior history of SRT: Presence of at least 1 independently verified, non-irradiated, measurable brain metastasis, defined as at least 5 mm AND twice the MRI slice thickness, but less than or equal to 3 cm, that can be accurately assessed at baseline and suitable for accurate repeated measurements.
✓. Has at least 1 measurable brain metastasis with prior history of SRT to other brain metastases: A history of SRT for brain metastases is allowed up to 1 week before study treatment provided that neurologic sequelae are resolved. If the patient will be enrolled to the study immediately after SRS it is encouraged to have 1-5 measurable untreated measurable lesion(s) remain, defined as at least 5 mm AND twice the MRI slice thickness, but less than or equal to 3 cm.
✓. Has no measurable brain metastasis with prior SRT: A history of immediate prior SRT for brain metastases is allowed up to 1 week before study treatment provided that neurologic sequelae are resolved.
✓. If the patient had prior SRT, progression in irradiated lesion must have occurred at least 1 month after the end of radiation therapy for the irradiated lesion to be counted as measurable.
✓. Patients can have asymptomatic (no neurologic signs or symptoms, not requiring immediate local intervention \[surgery or radiosurgery\] or systemic \>10 mg prednisone or equivalent per day glucocorticoid therapy \[within 10 days prior to study treatment initiation\]) OR minimally symptomatic brain metastases (requiring .10 mg prednisone or equivalent per day and not requiring immediate surgical or radiation therapy in the opinion of the treating investigator and a radiation therapy or neurosurgical consultant).
Exclusion criteria
✕. Has symptomatic brain metastasis requiring immediate procedure (surgery, radiation treatment), or corticosteroids in dosing exceeding 10 mg daily of prednisone equivalent.
✕. Has received whole brain radiation treatment previously
✕. Has overt hemorrhagic brain metastasis
✕. Has received prior therapy with lenvatinib
✕. Has clinical or radiographic evidence of leptomeningeal disease
✕. Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility. Patients must have adequately recovered from major surgery and has no ongoing surgical complications.
✕. Has prior history of .Grade 3 toxicity attributed to immune checkpoint inhibitor treatment.
✕. Has severe hypersensitivity (.Grade 3) to pembrolizumab and/or any of its excipients.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year