Therapy Detail

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Therapy Name Avelumab + Cisplatin + Gemcitabine
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Avelumab Bavencio MSB0010718C Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 Bavencio (avelumab) is a monoclonal antibody binds to human immunosuppressive ligand programmed death-ligand 1 (PD-L1, CD274) and blocks protein signaling, resulting in immune regulation and antitumor immunity (PMID: 26014098). Bavencio (avelumab) is FDA-approved for use in adult and pediatric patients of 12 years or older with metastatic Merkel cell carcinoma, as maintenance therapy in locally advanced or metastatic urothelial carcinoma (UC), in locally advanced or metastatic UC that progressed following chemotherapy, and in combination with axitinib as first-line therapy in advanced renal cell carcinoma (FDA.gov).
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).

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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
NCT03317496 Phase II Avelumab + Cisplatin + Gemcitabine Avelumab + Carboplatin + Pemetrexed Disodium Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies Terminated USA | ITA | HUN | GBR | ESP | CZE | CAN | AUS 0
NCT06225596 Phase II Avelumab + Carboplatin + Gemcitabine Avelumab + Cisplatin + Gemcitabine BT8009 BT8009 + Pembrolizumab Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) Recruiting USA | TUR | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | ARG 5
NCT04887831 Phase II Cisplatin + Gemcitabine + Trilaciclib Avelumab + Trilaciclib Carboplatin + Gemcitabine + Trilaciclib Avelumab + Cisplatin + Gemcitabine Avelumab + Carboplatin + Gemcitabine Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab (PRESERVE3) Terminated USA | HUN | FRA | ESP 1
NCT03674424 Phase II Avelumab + Gemcitabine + Paclitaxel Avelumab + Cisplatin + Doxorubicin + Methotrexate + Vinblastine Avelumab Avelumab + Cisplatin + Gemcitabine Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers (AURA Trial) (AURA) Active, not recruiting FRA | BEL 0
NCT03324282 Phase II Cisplatin + Gemcitabine Avelumab + Cisplatin + Gemcitabine First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma (GCISAVE) Terminated FRA 0


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