Therapy Detail

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Therapy Name Cisplatin + Durvalumab + Gemcitabine
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).
Durvalumab Imfinzi MEDI4736 Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, PMID: 28214651). Imfinzi (durvalumab) is FDA-approved for use in patients with urothelial carcinoma and unresectable, stage III non-small cell lung cancer, in combination with Imjudo (tremelimumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations, in combination with platinum-based chemotherapy as neoadjuvant therapy followed by surgery and adjuvant Imfinzi (durvalumab) in patients with resectable non-small cell lung cancer, in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer, in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma, and in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient endometrial cancer (FDA.gov).
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).

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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
NCT03875235 Phase III Cisplatin + Gemcitabine Cisplatin + Durvalumab + Gemcitabine A Global Phase III Study of Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) Active, not recruiting USA | TUR | POL | ITA | GBR | FRA | BGR | ARG 9
NCT05712356 Phase II CEND-1 + Cisplatin + Durvalumab + Gemcitabine Cisplatin + Durvalumab + Gemcitabine Paclitaxel Docetaxel CEND-1 + Docetaxel CEND-1 + Paclitaxel A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (BOLSTER) Recruiting USA | ESP 0
NCT03775486 Phase II Durvalumab + Olaparib Cisplatin + Durvalumab + Pemetrexed Disodium Durvalumab Carboplatin + Durvalumab + Gemcitabine Carboplatin + Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Nab-paclitaxel Cisplatin + Durvalumab + Gemcitabine Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION) (ORION) Active, not recruiting USA | POL | NLD | HUN | GBR | BEL 6
NCT03732677 Phase III Cisplatin + Gemcitabine Cisplatin + Durvalumab + Gemcitabine Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NIAGARA) Active, not recruiting USA | TUR | POL | NLD | ITA | ISR | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS 7
NCT03682068 Phase III Carboplatin + Durvalumab + Gemcitabine Carboplatin + Durvalumab + Gemcitabine + Tremelimumab Cisplatin + Durvalumab + Gemcitabine Cisplatin + Durvalumab + Gemcitabine + Tremelimumab Cisplatin + Gemcitabine Carboplatin + Gemcitabine Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer (NILE) Active, not recruiting USA | TUR | POL | ITA | ISR | HUN | ESP | CZE | CAN | BRA | BGR | AUS | ARG 9
NCT06282575 Phase III Cisplatin + Durvalumab + Gemcitabine Cisplatin + Gemcitabine + Pembrolizumab Cisplatin + Durvalumab + Gemcitabine + ZW25 Cisplatin + Gemcitabine Cisplatin + Gemcitabine + Pembrolizumab + ZW25 Cisplatin + Gemcitabine + ZW25 Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer Recruiting USA | ITA | ISR | ESP | CAN | ARG 8
NCT06440993 Phase II Cisplatin + Durvalumab + Gemcitabine Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma Recruiting DEU 0
NCT06274879 Phase II Cisplatin + Durvalumab + Gemcitabine Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer (Ablatio) Not yet recruiting CHE 0
NCT06546969 Phase I Cisplatin + Durvalumab + Gemcitabine Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer Not yet recruiting USA 0
NCT03912818 Phase II Cisplatin + Durvalumab + Gemcitabine Cisplatin + Doxorubicin + Durvalumab + Methotrexate + Vinblastine Carboplatin + Durvalumab + Gemcitabine Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer Terminated USA 0
NCT05771480 Phase III Durvalumab + Gemcitabine + Oxaliplatin Cisplatin + Durvalumab + Gemcitabine + Tegafur-gimeracil-oteracil Potassium Durvalumab + Gemcitabine + Tegafur-gimeracil-oteracil Potassium Cisplatin + Durvalumab + Gemcitabine Durvalumab + Gemcitabine Carboplatin + Durvalumab + Gemcitabine Cisplatin + Durvalumab + Gemcitabine + Nab-paclitaxel Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (TOURMALINE) Recruiting USA | ITA | FRA | ESP | DEU 3
NCT06375915 Phase II Cisplatin + Durvalumab + Gemcitabine Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy (PM-CARE) Recruiting ITA 0
NCT06050252 Phase II Cisplatin + Durvalumab + Gemcitabine Durvalumab With Gemcitabine and Cisplatin for the Treatment of High Risk Resectable Liver Cancer Before Surgery Recruiting USA 0
NCT03800134 Phase III Cisplatin + Durvalumab + Gemcitabine Carboplatin + Paclitaxel Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Carboplatin + Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Paclitaxel Cisplatin + Durvalumab + Pemetrexed Disodium Cisplatin + Gemcitabine A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer Active, not recruiting USA | ROU | POL | NLD | ITA | HUN | FRA | ESP | DEU | CAN | BRA | BGR | BEL | AUT | ARG 13
NCT06467357 Phase III Cisplatin + Durvalumab + Gemcitabine Trastuzumab deruxtecan AZD2936 + Trastuzumab deruxtecan Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer (DESTINY-BTC01) Recruiting USA | SVK | POL | NLD | ITA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS 9


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