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Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

Status
Active
Cancer Type
Prostate Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male
Study Type
Treatment
NCT ID
NCT04848337
Protocol IDs
HCRN GU19-385 (primary)
NCI-2021-06868
Study Sponsor
University of Michigan Rogel Cancer Center

Summary

Eligible patients will be treated with the combination of lenvatinib and pembrolizumab. A
cycle equals 21 days and therapy will continue until radiographic progression, intolerable
toxicity, or patient/physician wishes to discontinue protocol therapy. A maximum of 35 cycles
may be administered. On Day 1, when both pembrolizumab and lenvatinib are administered,
patients should take the lenvatinib per their normal routine.

Eligibility

  1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  2. Age = 18 years at the time of consent.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the date of registration.
  4. The subject has histologically proven prostate cancer with radiologic evidence of metastases and at least one of the following:
  5. Small-cell or NEPC morphology (determined by the enrolling center) on the basis of tissue sample.
  6. Prostate adenocarcinoma with greater than 50% IHC staining for neuroendocrine markers (e.g., chromogranin and synaptophysin).
  7. Presence of visceral metastases or high volume disease (> 4 sites of metastases) with a PSA of = 5.
  8. Serum chromogranin A level = 5× upper limit of normal (ULN) and/or serum neuron specific enolase (NSE) = 2× ULN.
  9. RBI deletions or mutations noted on genomic testing.
  10. Trans-differentiated carcinoma or poorly-differentiated carcinoma.
  11. Subject has adequate organ function as defined in the table below; all screening labs to be obtained within 10 days prior to Cycle 1 Day 1.
  12. Absolute neutrophil count (ANC) = 1500/mm3without colony stimulating factor support
  13. Platelets = 100,000/mm3
  14. Hemoglobin = 9 g/dL. Transfusions are allowed as needed.
  15. Serum creatinine = 1.5 x ULN or creatinine clearance (CrCl) = 30 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used.
  16. Bilirubin = 1.5 x the upper limit of normal (ULN) OR direct bilirubin =ULN for participants with total bilirubin levels >1.5 × ULN. For subjects with known Gilbert's disease, bilirubin = 3.0 mg/dL
  17. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN if no liver involvement, or = 5 and/or ULN with liver involvement
  18. International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT) =1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
  19. Urine protein < 2+ by urine dipstick
  20. A male participant must agree to use of contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
  21. Projected life expectancy of at least 6 months as determined by treating physician.
  22. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
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