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 | 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 151 PD-L1/PD-1 antibody 98 | 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, NSCLC and CD274 (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 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 first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CD274 positive | esophageal cancer | sensitive | Cisplatin + Fluorouracil + Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) in combination with first-line chemotherapy including Adrucil (fluorouracil) and Platinol (cisplatin), is included in guidelines as preferred first-line therapy for patients with esophageal cancer expressing PD-L1 (CD274, CPS>=10), and without ERBB2 (HER2) overexpression (category 1), and as first-line therapy for patients with PD-L1 expression (CD274, CPS <10) and without ERBB2 (HER2) overexpression (category 2B) (NCCN.org). | detail... |
| CD274 positive | esophagus squamous cell carcinoma | sensitive | Cisplatin + Fluorouracil + Pembrolizumab | Phase III | Actionable | In a Phase III trial (KEYNOTE-590), addition of Keytruda (pembrolizumab) to cisplatin and fluorouracil significantly improved overall survival (13.9 vs 8.8 mo, HR=0.57, p<0.0001) and progression-free survival (6.3 vs 5.8 mo, HR=0.65, p<0.0001) in patients with metastatic or locally advanced esophageal squamous cell carcinoma expressing PD-L1 (CPS>=10) (Ann Oncol. 31, no. 4_suppl (Sep 2020) S1192-S1193; NCT03189719). | detail... |
| CD274 positive | gastroesophageal junction adenocarcinoma | sensitive | Cisplatin + Fluorouracil + Pembrolizumab | Phase III | Actionable | In a Phase III trial (KEYNOTE-590), addition of Keytruda (pembrolizumab) to cisplatin and fluorouracil significantly improved overall survival (13.5 vs 9.4 mo, HR=0.62, p<0.0001) and progression-free survival (7.5 vs 5.5 mo, HR=0.51, p<0.0001) in patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma expressing PD-L1 (CPS>=10) (Ann Oncol. 31, no. 4_suppl (Sep 2020) S1192-S1193; NCT03189719). | detail... |
| CD274 positive | gastroesophageal junction adenocarcinoma | sensitive | Cisplatin + Fluorouracil + Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) in combination with first-line chemotherapy including Adrucil (fluorouracil) and Platinol (cisplatin), is included in guidelines as preferred first-line therapy for patients with esophagogastric junction adenocarcinoma expressing PD-L1 (CD274, CPS>=10), and without ERBB2 (HER2) overexpression (category 1), and as first-line therapy for patients with PD-L1 expression (CD274, CPS <10) and without ERBB2 (HER2) overexpression (category 2B) (NCCN.org). | detail... |
| CD274 positive | head and neck squamous cell carcinoma | sensitive | Cisplatin + Fluorouracil + Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) in combination with platinum and Adrucil (fluorouracil) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with CD274 (PD-L1)-positive (CPS >/=1) recurrent or metastatic head and neck squamous cell carcinoma (PMID: 34844180; ESMO.org). | detail... 34844180 |
| CD274 positive | esophageal carcinoma | sensitive | Cisplatin + Fluorouracil + Pembrolizumab | Phase III | Actionable | In a Phase III trial (KEYNOTE-590), addition of Keytruda (pembrolizumab) to cisplatin and fluorouracil significantly improved overall survival (13.5 vs 9.4 mo, HR=0.62, p<0.0001) and progression-free survival (7.5 vs 5.5 mo, HR=0.51, p<0.0001) in patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma expressing PD-L1 (CPS>=10) (Ann Oncol. 31, no. 4_suppl (Sep 2020) S1192-S1193; NCT03189719). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | |
| 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 | FRA | ESP | CAN | 15 |
| 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 | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 12 |
| 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 | 1 |
| 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 | FRA | ESP | DEU | CAN | 21 |
| 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 | FRA | DEU | CAN | BEL | 18 |
| 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 | ITA | FRA | ESP | DEU | CAN | 27 |
| 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 | ITA | FRA | DEU | CAN | BEL | 19 |
| 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 | Recruiting | USA | ITA | FRA | ESP | DEU | BEL | 4 |
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