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 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). |
| Sacituzumab govitecan-hziy | Trodelvy | IMMU-132|Sactizumab|Sacituzumab govitecan | TROP2 Antibody 13 | 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, in patients with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies, and in patients with locally advanced or metastatic urothelial cancer who received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor (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 |
|---|---|---|---|---|---|---|
| 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/NSABP B-63) | Recruiting | USA | 0 |
| NCT05535218 | Phase II | Pembrolizumab + Sacituzumab govitecan-hziy | Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer (SURE-02) | Enrolling by invitation | ITA | 0 |
| 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 |
| NCT04448886 | Phase II | Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy | Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC | Active, not recruiting | USA | 0 |
| 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) | Recruiting | USA | TUR | ROU | POL | LVA | LTU | ITA | ISR | GRC | GBR | EST | DEU | CAN | BRA | AUS | 9 |
| 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 | ROU | POL | NZL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | ESP | CHE | CAN | BRA | BEL | AUS | ARG | 12 |
| 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 |
| 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) | Recruiting | USA | 0 |
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