A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684 Based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Primary:
- Safety Lead-in: To evaluate the safety and tolerability, and to establish a RP2D, of treatment combinations that have not been evaluated in a separate study.
- Efficacy Phase: To evaluate the safety and tolerability for each treatment arm.
- Efficacy Phase: To estimate the PSA response rate for each treatment arm.
Secondary:
- Efficacy Phase: To estimate the ORR per PCWG Modified RECIST 1.1, as assessed by BICR, for each treatment arm.
- Efficacy Phase: To evaluate rPFS per PCWG Modified RECIST 1.1, as assessed by BICR, for each treatment arm.
- Efficacy Phase: To evaluate OS for each treatment arm.
- Efficacy Phase: To evaluate the DOR as assessed by BICR for each treatment arm.
- Efficacy Phase: To evaluate the TFST for each treatment arm.
- Efficacy Phase: To evaluate the TTPP for each treatment arm.
DOCETAXEL
MK-5684
Olaparib
Chemotherapy single agent systemic
- Rutgers University
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the
prostate without small cell histology.
- Prostate cancer progression and received androgen deprivation therapy (ADT) or post
bilateral orchiectomy within 6 months before screening.
- Evidence of disease progression from either, >4 weeks from last flutamide treatment,
or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first
generation anti-androgen therapy as last treatment therapy.
- Current evidence of metastatic disease.
- Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or
metastatic, hormone-sensitive prostate cancer or castration-resistant prostate
cancer and have disease progression during or after treatment.
- Treatment with bone resorptive therapy (including, but not limited to,
bisphosphonate or denosumab) must have been on stable doses for >4 weeks before
randomization.
- Participants who experienced adverse events (AEs) due to previous anticancer
therapies must have recovered to
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.