Therapy Detail

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Therapy Name Enzalutamide + Pembrolizumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Enzalutamide Xtandi MDV3100|ASP9785 Hormone - Anti-androgens 49 Xtandi (enzalutamide) is a second-generation small molecule inhibitor of androgen receptor, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA-approved for use in patients with castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (FDA.gov).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 148 PD-L1/PD-1 antibody 117 Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04116775 Phase II Enzalutamide + Pembrolizumab Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer. Unknown status USA 0
NCT02312557 Phase II Enzalutamide + Pembrolizumab Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide Active, not recruiting USA 0
NCT02861573 Phase I Dexamethasone + Docetaxel + Pembrolizumab + Prednisone Olaparib + Pembrolizumab Enzalutamide + Pembrolizumab Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) Recruiting USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 9
NCT03834493 Phase III Enzalutamide + Pembrolizumab Enzalutamide Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) Active, not recruiting USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 17
NCT03753243 Phase II Enzalutamide + Pembrolizumab Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer Unknown status USA 0
NCT04191096 Phase III Enzalutamide + Pembrolizumab Enzalutamide Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Active, not recruiting USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 18


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