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 6 | Platinol (cisplatin) is a platinum based chemotherapeutic, which is FDA approved for bladder, ovarian, and testicular cancers (NCI Drug Dictionary). |
| Fluorouracil | Adrucil | 5-FU | Chemotherapy - Antimetabolite 12 | 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 98 PD-L1/PD-1 antibody 68 | 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 squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, PD-L1 expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast cancer, in combination 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 in RCC, and with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | head and neck squamous cell carcinoma | not applicable | Cisplatin + Fluorouracil + Pembrolizumab | FDA approved | Actionable | In a Phase III trial (KEYNOTE-048) that supported FDA approval, Keytruda (pembrolizumab) in combination with platinum and Adrucil (fluorouracil) significantly improved overall survival compared to Erbitux (cetuximab) plus chemotherapy (13.0 vs 10.7 months, HR=0.77, p=0.0067) in patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (J Clin Oncol 37, no. 15_suppl (May 20 2019) 6000-6000; NCT02358031). | detail... detail... |
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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) | Recruiting | USA | CAN | 23 |
| 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) | Active, not recruiting | 0 | |
| NCT03189719 | Phase III | Cisplatin + Fluorouracil Cisplatin + Fluorouracil + Pembrolizumab | First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590) | Active, not recruiting | USA | CAN | 24 |
| 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) | Recruiting | USA | CAN | 31 |
| 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 | CAN | 22 |
| 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 | Recruiting | USA | CAN | 17 |
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