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Therapy Name | Cisplatin + Fluorouracil + Pembrolizumab |
Synonyms | |
Therapy Description | |
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 149 PD-L1/PD-1 antibody 122 | 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, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, 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 chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
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 | esophagus squamous cell carcinoma | 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 locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma expressing PD-L1 (CD274) with CPS >/= 10 (category 1) and for patients with CPS <10 (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 | esophagus 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 locally advanced, recurrent, or metastatic ERBB2 (HER2) overexpression-negative esophageal adenocarcinoma expressing PD-L1 (CD274) with CPS >/= 10 (category 1) or with CPS >/= 1 and <10 (category 2B) (NCCN.org). | 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 locally advanced, recurrent, or metastatic ERBB2 (HER2) overexpression negative gastroesophageal junction adenocarcinoma expressing PD-L1 (CD274) with CPS >/= 10 (category 1) or with CPS >/=1 and <10 (category 2B) (NCCN.org). | 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 | 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... |
CD274 positive | gastric adenocarcinoma | sensitive | Cisplatin + Fluorouracil + Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) in combination with a fluoropyrimidine (Adrucil (fluorouracil) or Xeloda (capecitabine)) and platinum-containing chemotherapy (Platinol (cisplatin) or Eloxatin (oxaliplatin)) is included in guidelines as a preferred first-line therapy for patients with locally advanced, unresectable, or metastatic gastric adenocarcinoma expressing CD274 (PD-L1, CPS>/=10; category 1) or CD274 (PD-L1, CPS>/=1 and <10; category 2B) and without ERBB2 (HER2) overexpression (NCCN.org). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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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 |
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 | Terminated | USA | POL | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 2 |
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 | POL | LVA | LTU | ITA | ISR | GBR | FRA | EST | DEU | CAN | BRA | BEL | 11 |
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 | TUR | POL | NZL | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | AUS | ARG | 14 |
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 |
NCT06557889 | Phase II | Carboplatin + Fluorouracil + Pembrolizumab Cisplatin + Fluorouracil + Pembrolizumab | Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas (REDUCE) | Recruiting | FRA | 0 |
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 | TUR | ROU | ITA | HUN | GBR | FRA | EST | DNK | DEU | CZE | CAN | BRA | BEL | ARG | 12 |
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 | TUR | ROU | GBR | FRA | ESP | DNK | DEU | CAN | BRA | AUS | ARG | 14 |
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 | SWE | ROU | POL | ITA | IRL | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL | AUS | ARG | 3 |
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 | TUR | ROU | ITA | HUN | GBR | FRA | ESP | DNK | CAN | ARG | 14 |
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) | Active, not recruiting | USA | NLD | GBR | ESP | BEL | AUS | 2 |
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 |