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 54 | 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 149 PD-L1/PD-1 antibody 121 | 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 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, 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 |
|---|---|---|---|---|---|---|
| NCT02312557 | Phase II | Enzalutamide + Pembrolizumab | Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide | Active, not recruiting | USA | 0 |
| 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 |
| NCT04116775 | Phase II | Enzalutamide + Pembrolizumab | Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer. | Unknown status | USA | 0 |
| 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 | FIN | ESP | DNK | DEU | CAN | AUS | 2 |
| 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 |
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