Therapy Detail
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| Therapy Name | Pembrolizumab + Sacituzumab govitecan-hziy |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| 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). |
| Sacituzumab govitecan-hziy | Trodelvy | IMMU-132|Sactizumab|Sacituzumab govitecan | TROP2 Antibody 18 | Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate (ADC) composed of a monoclonal anti-TROP2 antibody linked to the active metabolite of irinotecan (SN-38), which binds to TROP2 positive cancer cells and induces DNA breakage and apoptosis (PMID: 26541586). Trodelvy (sacituzumab govitecan-hziy) is FDA approved for use in patients with metastatic triple-negative breast cancer who received two or more prior therapies,and in patients with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies (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 |
|---|---|---|---|---|---|---|
| NCT05609968 | Phase III | Pembrolizumab Pembrolizumab + Sacituzumab govitecan-hziy | Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) >=50% (MK-3475-D46) | Active, not recruiting | USA | TUR | ROU | POL | LVA | LTU | ITA | ISR | GRC | GBR | EST | DEU | CAN | BRA | AUS | 10 |
| NCT05675579 | Phase II | Pembrolizumab + Sacituzumab govitecan-hziy | A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC) | Active, not recruiting | USA | 0 |
| NCT06524544 | Phase III | Cisplatin + Gemcitabine Carboplatin + Gemcitabine Pembrolizumab + Sacituzumab govitecan-hziy Paclitaxel Docetaxel | A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Standard of Care in the Treatment of Advanced Urothelial Cancer | Recruiting | USA | 0 |
| NCT05186974 | Phase II | Pembrolizumab + Sacituzumab govitecan-hziy Carboplatin + Pembrolizumab + Sacituzumab govitecan-hziy Cisplatin + Pembrolizumab + Sacituzumab govitecan-hziy | Study of Sacituzumab Govitecan-hziy Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations (EVOKE-02) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 4 |
| NCT06788912 | Phase II | Cisplatin + Gemcitabine + Pembrolizumab Carboplatin + Gemcitabine + Pembrolizumab Pembrolizumab + Sacituzumab govitecan-hziy Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Paclitaxel + Pembrolizumab Cisplatin + Paclitaxel + Pembrolizumab Carboplatin + Pembrolizumab + Pemetrexed Disodium | Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01) | Recruiting | USA | TUR | POL | ITA | HUN | GRC | ESP | 2 |
| NCT05382286 | Phase III | Pembrolizumab + Sacituzumab govitecan-hziy Carboplatin + Gemcitabine + Pembrolizumab Paclitaxel + Pembrolizumab Nab-paclitaxel + Pembrolizumab | Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-04) | Active, not recruiting | USA | TUR | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 9 |
| NCT04468061 | Phase II | Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy | Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC | Recruiting | USA | 0 |
| NCT05633654 | Phase III | Pembrolizumab + Sacituzumab govitecan-hziy Capecitabine + Pembrolizumab Pembrolizumab | Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63) | Recruiting | USA | IRL | GBR | FRA | ESP | DEU | AUS | 1 |
| NCT04448886 | Phase II | Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy | Sacituzumab Govitecan +/- Pembrolizumab in HR+ / HER2 - MBC | Active, not recruiting | USA | 0 |
| NCT06081244 | Phase II | Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy | NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III) (ADAPT-TN-III) | Recruiting | DEU | 0 |
| NCT05535218 | Phase II | Pembrolizumab + Sacituzumab govitecan-hziy | Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer (SURE-02) | Active, not recruiting | ITA | 0 |
| NCT06312176 | Phase III | Paclitaxel Capecitabine Pegylated liposomal doxorubicin Nab-paclitaxel Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy | A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) | Recruiting | USA | TUR | SWE | ROU | POL | NZL | NLD | ITA | ISR | IRL | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUS | ARG | 16 |
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