Therapy Detail

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Therapy Name Cisplatin + Fluorouracil + Pembrolizumab
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).
Fluorouracil Adrucil 5-FU|5-Fluorouracil Chemotherapy - Antimetabolite 14 Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov).
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).

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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
NCT04210115 Phase III Cisplatin + Fluorouracil + Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Cisplatin + Fluorouracil Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) Active, not recruiting USA | ITA | GBR | FRA | DEU | CAN | BEL 20
NCT02335411 Phase II Cisplatin + Fluorouracil + Pembrolizumab Pembrolizumab A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059) Completed 0
NCT04675333 Phase II Carboplatin + Evorpacept + Fluorouracil + Pembrolizumab Cisplatin + Fluorouracil + Pembrolizumab Carboplatin + Fluorouracil + Pembrolizumab Cisplatin + Evorpacept + Fluorouracil + Pembrolizumab ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) Recruiting USA | ESP | BEL | AUS 0
NCT04428333 Phase III Carboplatin + Fluorouracil + Pembrolizumab Cisplatin + Fluorouracil + GSK3359609 + Pembrolizumab Cisplatin + Fluorouracil + Pembrolizumab Carboplatin + Fluorouracil + GSK3359609 + Pembrolizumab Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Terminated USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 11
NCT04949256 Phase III Cisplatin + Fluorouracil + Pembrolizumab Cisplatin + Fluorouracil + Lenvatinib + Pembrolizumab Fluorouracil + Lenvatinib + Leucovorin + Oxaliplatin + Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014) Recruiting USA | ITA | GBR | FRA | ESP | CAN 19
NCT03189719 Phase III Cisplatin + Fluorouracil Cisplatin + Fluorouracil + Pembrolizumab First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590) Completed USA | GBR | FRA | ESP | DEU | CAN | AUS 19
NCT03675737 Phase III Capecitabine + Oxaliplatin Capecitabine + Oxaliplatin + Pembrolizumab Cisplatin + Fluorouracil + Pembrolizumab Cisplatin + Fluorouracil Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859) Active, not recruiting USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUS 24
NCT04854499 Phase II Carboplatin + Fluorouracil + Pembrolizumab Docetaxel + Hu5F9-G4 Cisplatin + Fluorouracil + Pembrolizumab Hu5F9-G4 + Pembrolizumab Carboplatin + Fluorouracil + Hu5F9-G4 + Pembrolizumab Cisplatin + Fluorouracil + Hu5F9-G4 + Pembrolizumab Study of Magrolimab Combination Therapy in Participants With Head and Neck Squamous Cell Carcinoma Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | BEL | AUS 3
NCT03221426 Phase III Capecitabine + Cisplatin Capecitabine + Cisplatin + Pembrolizumab Cisplatin + Fluorouracil + Pembrolizumab Cisplatin + Fluorouracil Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) Active, not recruiting USA | ITA | GBR | FRA | DEU | CAN | BEL 17
NCT06236425 Phase I Cisplatin + Pembrolizumab Aldesleukin Carboplatin + Fluorouracil + Pembrolizumab TBio-4101 Cyclophosphamide + Fludarabine Cisplatin + Fluorouracil + Pembrolizumab TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC Recruiting USA 0
NCT05721755 Phase III Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab Cisplatin + Fluorouracil + Pembrolizumab Carboplatin + Fluorouracil + Pembrolizumab Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck Recruiting USA 0


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