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PROSTATE: METASTATIC: Pembro+Lenvatinib: 2nd or 3rd line chemo: KEYNOTE-365 ARM E

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

Merck KEYNOTE-365 ARM E Pembro+Lenvatinib
Study Title

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

Site Link
Disease Setting
Line Of Therapy
> or - 2nd line
Investigational Agent
Pembrolizumab, Lenvatinib
Drug Class
PD-1 inhibitor, VEG-F TKI
Dan Vaena, MD
Merck Sharp and Dohme
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
  • Must provide a core or excisional biopsy from soft tissue or bone biopsy from soft tissue within 1 year of screening and after developing mCRPC
  • Has prostate cancer progression within 6 months prior to screening by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
  • Ongoing androgen deprivation with serum testoterone <50ng/dL
  • Stable doses of bone resorptive therapy
  • ECOG PS 0-1
  • Has previously received docetaxel for mCRPC. Prior treatment with one other chemotherapy is allowed. Up to 2 second-generation hormonal agents (eg. abiraterone, enzalutimide, etc.) are allowed. Prior ketoconazole is allowed. Docetaxel used more than once is considered as 1 therapy.
  • No diagnosis of immunodeficiency or systemic steroid therapy
  • No autoimmune disease within last 2 years
  • No known HBV/HCV/HIV
  • No known active CNS mets
  • No superscan bone scan
  • No active cardiovascular disease
  • No gastrointestinal malabsortion
  • No active hemoptysis
  • Primary
    • Percentage of patients with decrease of >/= 50% in PSA
    • AE
    • ORR
  • Secondary
    • DCR
    • OS
    • DOR
    • ORR based on PCWG3-modifeid RECIST
    • Time to PSA progression
    • Radiographic PFS
    • Composite Response Rate (PSA Decrease,, RECIST)
Assessment Frequency
Assessment Frequency 2

Assessment Frequency Link
Prostate Adenocarcinoma without small cell histology
Dosing Frequency
Control Agents
Study Protocol