This study is being performed as a single-arm open-label study in order to provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with advanced ccRCC who have progressed on Pembrolizumab as their prior therapy in the adjuvant RCC setting.
Male or female
Age >18 years at the time of signing the informed consent
Histological confirmation of RCC with a clear-cell component
Has locally recurrent/metastatic disease (ie, Stage IV per the American Joint Committee on Cancer)
Treatment with any anti-cancer therapy as first line therapy after adjuvant therapy with pembrolizumab
Adjuvant treatments other than Pembrolizumab
Patients with non clear cell RCC
Symptomatic, untreated, or actively progressing CNS metastases (patient has no history of intracranial hemorrhage or spinal cord hemorrhage; patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment; no evidence of significant vasogenic edema; patient has no ongoing requirement for corticosteroids as therapy for CNS disease but anticonvulsant therapy at a stable dose is permitted; CNS metastases limited to the cerebellum or the supratentorial region, no metastases to the midbrain, pons, medulla, or spinal cord; no evidence of interim progression between completion of CNS- directed therapy and initiation of study treatment)
Single group
Pembrolizumab 200 mg Q3W
DrugThe planned dose of pembrolizumab for this study is 200 mg IV every 3 weeks (Q3W). Pembrolizumab will be given for a maximum of 2 years i.e. a total of 35 cycles. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression
Lenvatinib 20mg QD
DrugThe planned dose of Lenvatinib for this study is 20 mg once daily (QD). Lenvatinib will be taken orally until confirmed disease progression or intolerable adverse event(s).
Primary outcome
PFS: the time from first dose to the first documented PD or death from any cause, whichever occurs first
Primary outcome
Objective response (OR): a confirmed complete response (CR) or partial response (PR)
Secondary outcome
To evaluate the duration of response (DOR) of pembrolizumab + lenvatinib in participants with a confirmed CR or PR per RECIST 1.1
Secondary Outcome
To evaluate the overall survival (OS) of participants receiving pembrolizumab + lenvatinib
Secondary outcome
To evaluate clinical benefit rate (CBR) per RECIST 1.1 in participants receiving pembrolizumab + lenvatinib
Secondary outcome
To evaluate disease control rate (DCR) per RECIST 1.1 in participants receiving pembrolizumab + lenvatinib
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This trial is not recruiting at the moment. You can still explore other options:
