About this trial
This phase 1b trial is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) and pembrolizumab in patients with metastatic castration resistant prostate cancer (mCRPC).
Eligibility criteria
Qualifiers
Patient must have provided written informed consent using the LumOnate Patient Information and Consent Form (PICF)
Patient must be ≥ 18 years of age at Screening
Willing and able to comply with treatment schedule, laboratory testing, and other requirements of the study
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation
Disqualifiers
Prior chemotherapy for mCRPC. Prior docetaxel is permitted if given in the setting of hormone sensitive disease
Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax < 10
Extensive marrow disease defined by a "Super Scan" on bone scintigraphy or diffuse marrow infiltration on PSMA PET
Active brain metastases or leptomeningeal metastases
Trial design
Treatments tested in this trial
- Olaparib (300 mg BID)
- Pembrolizumab
- 177Lu-PSMA-I&T