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Therapy Name | Enzalutamide + Pembrolizumab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Enzalutamide | Xtandi | MDV3100|ASP9785 | Hormone - Anti-androgens 42 | Xtandi (enzalutamide) is a second-generation small molecule androgen receptor (AR) inhibitor that inhibits AR signaling, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA approved for use in patients with castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer (FDA.gov). |
Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 109 | 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, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, 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 chemotherapy for patients with esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer (FDA.gov). |
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 |
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NCT03753243 | Phase II | Enzalutamide + Pembrolizumab | Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer | 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 | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 19 |
NCT02312557 | Phase II | Enzalutamide + Pembrolizumab | Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide | Active, not recruiting | 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 | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 20 |
NCT04116775 | Phase II | Enzalutamide + Pembrolizumab | Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer. | 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 | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 12 |