Next month, recruiting will begin for a great clinical trial for Keytruda (pembrolizumab), the anti-PD-1 immunotherapy. It’s already approved for melanoma, lung cancer, and head-and-neck cancer. Some of you may remember that this is the drug that Jimmy Carter attributes to his melanoma remission.
The really nice thing about
this trial is that everyone gets Keytruda. This is only for patients with metastatic castration-resistant prostate cancer (mCRPC). There are 3 cohorts. Patients will get Keytruda with a different combination of medicines depending upon which medicines they’ve used before. Cohort A (70 patients): Keytruda + Lynparza (olaparib)
Lynparza has demonstrated efficacy in men with certain genetic deficits that interfere with DNA repair (like mutations in the BRCA 1 and 2 genes). Patients must have already had Taxotere (docetaxel) therapy previously. Prior treatment with Zytiga, Xtandi or both is allowed.Cohort B (70 patients): Keytruda + Taxotere (docetaxel)
This is for patients who have not yet received Taxotere infusions for metastatic PC. Eligible patients must
have received prior Zytiga or Xtandi but not both
. They must have good performance status.Cohort C (70 patients): Keytruda + Xtandi (enzalutamide)
have received prior Zytiga, but not prior Xtandi. They may have received Taxotere for metastatic hormone-sensitive
PC, but not
for metastatic castration-resistant
There does not appear to be any exclusion for prior use of Provenge or any other investigational immunotherapy taken at least 4 weeks prior to starting on the study.
Tumor tissue samples must be provided.
There are other exclusions due to certain co-morbidities, and recent use of other drugs. You can check the exclusion criteria in the following link:/clinicaltrials.gov/ct2/show/NCT02861573
It’s scheduled to start in September, and I hope it will be in multiple locations. It has started recruiting in all locations
. If you think you qualify, you may want to forward the link to your medical oncologist and begin discussions about
it.added recruitment update