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 147 PD-L1/PD-1 antibody 117 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 SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemotherapy in NSCLC, 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 CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, and in combination with chemoradiation for cervical cancer (FDA.gov).
Sacituzumab govitecan-hziy Trodelvy IMMU-132|Sactizumab|Sacituzumab govitecan TROP2 Antibody 7 Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate 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
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) Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 18
NCT04448886 Phase II Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Active, not 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
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
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 | ITA | GBR | DEU | CAN | AUS 18
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
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) Recruiting USA 0
NCT04468061 Phase II Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC Recruiting USA 0


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