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 58 | 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 150 PD-L1/PD-1 antibody 136 | 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, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and 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, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium cancer (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 |
|---|---|---|---|---|---|---|
| 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 | TUR | POL | NZL | NLD | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | AUT | AUS | ARG | 8 |
| NCT02312557 | Phase II | Enzalutamide + Pembrolizumab | Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide | Active, not recruiting | USA | 0 |
| NCT04116775 | Phase II | Enzalutamide + Pembrolizumab | Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant 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 | TUR | POL | NZL | NLD | ITA | ISR | IRL | GBR | FRA | FIN | ESP | DNK | DEU | CHE | CAN | BRA | AUT | AUS | 10 |
| NCT03753243 | Phase II | Enzalutamide + Pembrolizumab | Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer | Unknown status | 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 | TUR | SWE | POL | NZL | NLD | ITA | IRL | GBR | FRA | ESP | DNK | CAN | AUS | 1 |
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