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Therapy Name Cisplatin + Gemcitabine + Pembrolizumab + Zanidatamab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cisplatin Platinol CDDP Chemotherapy - Platinum 7 Platinol (cisplatin) is a platinum based chemotherapeutic, which is FDA approved for bladder, ovarian, and testicular cancers (NCI Drug Dictionary).
Gemcitabine Gemzar Difluorodeoxycytidine Hydrochlorothiazide|LY-188011 Chemotherapy - Antimetabolite 14 Gemzar (gemcitabine) is converted in cells to difluorodeoxycytidine di- and triphosphate (dFdCDP, dFdCTP), which act to inhibit ribonucleoside reductase and as a deoxynucleotide analog respectively, resulting in DNA strand termination and apoptosis (NCI Drug Dictionary).
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).
Zanidatamab Ziihera ZW-25|ZW25|Zanidatamab-hrii HER2 (ERBB2) Antibody 80 Ziihera (zanidatamab) is a bispecific antibody targeting ERBB2 (HER2), which induces anti-tumor immune response against Erbb2 (Her2)-expressing tumors (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 255P, PMID: 32054397). Ziihera (zanidatamab) is FDA-approved for use in patients with unresectable or metastatic ERBB2 (HER2)-positive (IHC 3+) biliary tract cancer (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
NCT06282575 Phase III Cisplatin + Durvalumab + Gemcitabine Cisplatin + Gemcitabine + Pembrolizumab Cisplatin + Durvalumab + Gemcitabine + Zanidatamab Cisplatin + Gemcitabine Cisplatin + Gemcitabine + Pembrolizumab + Zanidatamab Cisplatin + Gemcitabine + Zanidatamab Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer Recruiting USA | TUR | SWE | ROU | ITA | ISR | GBR | FRA | FIN | ESP | DEU | CZE | CAN | BRA | BEL | ARG 9


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