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Therapy Name | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
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). |
Leucovorin | Wellcovorin | Calcium folinate|Calcium citrovorum factor|folinic acid | Chemotherapy - Antimetabolite 14 | Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554). |
Oxaliplatin | Eloxatin | Diaminocyclohexane Oxalatoplatinum | Chemotherapy - Platinum 7 | Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov). |
Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | 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 |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT02046538 | Phase II | Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Aflibercept | Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer | Withdrawn | USA | 0 |
NCT01571024 | Phase I | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Buparlisib | BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer | Completed | USA | 0 |
NCT01803282 | Phase I | Andecaliximab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Carboplatin + Pemetrexed Disodium Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Carboplatin + Paclitaxel Paclitaxel Bevacizumab | Safety and Tolerability Study in Solid Tumors | Completed | USA | 0 |
NCT06469944 | Phase Ib/II | Capecitabine + Oxaliplatin + Pembrolizumab Capecitabine + Pembrolizumab + SKB264 Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Fluorouracil + Pembrolizumab + SKB264 | Substudy 06C: A Study of Sacituzumab Tirumotecan (MK-2870) With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) | Recruiting | USA | NOR | CHE | 3 |
NCT01747551 | Phase II | Aflibercept Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer | Completed | USA | 0 |
NCT01896531 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Ipatasertib | A Study of GDC-0068 in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer | Completed | USA | ITA | GBR | FRA | ESP | DEU | 5 |
NCT02375672 | Phase II | Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer | Completed | USA | 0 |
NCT01327612 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Ganitumab Bevacizumab Conatumumab | Open Label Extension Study of Conatumumab and AMG 479 | Completed | USA | POL | ESP | 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 |
NCT03374254 | Phase I | Fluorouracil + Irinotecan + Leucovorin + Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Binimetinib + Fluorouracil + Irinotecan + Leucovorin + Pembrolizumab | Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651) | Completed | USA | CAN | 0 |
NCT02545504 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Andecaliximab | GS-5745 With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma | Completed | USA | TUR | ROU | POL | ITA | HUN | GBR | FRA | ESP | DEU | CZE | BEL | AUS | 3 |
NCT01666730 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Metformin | Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer | Completed | USA | 0 |
NCT02141295 | Phase II | Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin RO5520985 Bevacizumab + Fluorouracil + Leucovorin Fluorouracil + Leucovorin + RO5520985 Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | A Study Comparing the Efficacy and Safety of RO5520985 and FOLFOX With Bevacizumab and FOLFOX in Patients With Untreated Metastatic Colorectal Cancer (McCAVE) | Terminated | USA | GBR | FRA | ESP | BEL | AUT | AUS | 0 |
NCT01662869 | Phase III | Onartuzumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic HER2-Negative And Met-Positive Gastroesophageal Cancer (MetGastric) | Completed | USA | TUR | POL | ITA | ISR | GBR | FRA | ESP | DEU | CHE | CAN | BEL | AUS | 11 |
NCT02625610 | Phase III | Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Avelumab Capecitabine + Oxaliplatin | Avelumab in First-Line Gastric Cancer (JAVELIN Gastric 100) | Completed | USA | TUR | ROU | ITA | HUN | GBR | FRA | ESP | DEU | CAN | BRA | AUS | 5 |
NCT01420874 | Phase I | EGFRBi-armed autologous activated T cells Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Anti-CD3 x Anti-Erbitux Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer) | Completed | USA | 0 |
NCT02268825 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Pembrolizumab | Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers | Terminated | USA | 0 |
NCT02358863 | Phase I | Docetaxel + Irinotecan Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Cisplatin + Docetaxel Cisplatin + Irinotecan Docetaxel + Epirubicin Capecitabine + Docetaxel | Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach (mEGA) | Terminated | USA | 0 |
NCT01652976 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Dasatinib | Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma | Completed | USA | 0 |
NCT02213289 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Docetaxel + Fluorouracil Trastuzumab Fluorouracil + Irinotecan + Leucovorin Rilotumumab | PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression | Completed | USA | 0 |
NCT02730546 | Phase Ib/II | Carboplatin + Paclitaxel Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Pembrolizumab | Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery | Completed | USA | 0 |
NCT00602329 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Bevacizumab | MRI in Predicting Response in Patients Receiving Combination Chemotherapy and Bevacizumab For Advanced or Metastatic Colorectal Cancer | Terminated | USA | 0 |
NCT02319018 | Phase I | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Alisertib | Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors | Completed | USA | 0 |
NCT01206530 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Bevacizumab Hydroxychloroquine | FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer | Completed | USA | 0 |
NCT01516216 | Phase II | Bevacizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Study of Vitamin D in Untreated Metastatic Colorectal Cancer | Completed | USA | 0 |
NCT02024607 | Phase Ib/II | Capecitabine + Oxaliplatin Bevacizumab + Napabucasin Napabucasin + Regorafenib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Napabucasin Fluorouracil + Irinotecan + Leucovorin | A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer | Completed | USA | CAN | 0 |
NCT02921256 | Phase II | Veliparib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Capecitabine + Veliparib Capecitabine | Veliparib and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer | Completed | USA | 1 |
NCT02413853 | Phase II | Bevacizumab PRI-724 Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Combination Chemotherapy and Bevacizumab With or Without PRI-724 in Treating Patients With Newly Diagnosed Metastatic Colorectal Cancer | Withdrawn | USA | 0 |
NCT01260415 | Phase II | Panitumumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Fluorouracil + Irinotecan + Leucovorin | A Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver Metastases | Completed | CAN | 0 |
NCT01489865 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Veliparib | ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer | Unknown status | USA | 0 |
NCT02344810 | Phase Ib/II | AMG 337 Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | C-Met Inhibitor AMG 337, Oxaliplatin, Leucovorin Calcium, and Fluorouracil in Treating Patients With Advanced Stomach or Esophageal Cancer | Withdrawn | USA | 0 |
NCT03488667 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Perioperative mFOLFOX Plus Pembrolizumab in Gastroesophageal Junction (GEJ) and Stomach Adenocarcinoma | Active, not recruiting | USA | 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 | TUR | ROU | ITA | HUN | GBR | FRA | ESP | DNK | CAN | ARG | 14 |
NCT02943603 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | A Study of Perioperative mFOLFOX6 Plus Pembrolizumab in Patients With Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) and Stomach | Withdrawn | USA | 0 |
NCT01362374 | Phase I | Enzalutamide Paclitaxel Docetaxel Ipatasertib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Safety and Pharmacology Of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors | Completed | USA | GBR | FRA | ESP | 0 |
NCT01985763 | Phase Ib/II | Genistein Bevacizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Genistein in Treatment of Metastatic Colorectal Cancer | Completed | USA | 0 |
NCT02574663 | Phase I | Gemcitabine + Nab-paclitaxel Bevacizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Umbralisib | TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors | Completed | USA | 0 |
NCT01586611 | Phase III | Gemcitabine Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | A Study to See if hENT1 Testing on Tumour Tissue Can Predict Response to Treatment With Gemcitabine Chemotherapy and if a Different Chemotherapy Called FOLFOX is Better Than Gemcitabine in Metastatic Pancreas Cancer | Unknown status | CAN | 0 |
NCT05268510 | Phase II | Olaparib + Pembrolizumab Capecitabine + Oxaliplatin + Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib as Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma | Active, not recruiting | DEU | 0 |
NCT02872116 | Phase III | Capecitabine + Oxaliplatin Ipilimumab + Nivolumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab | Efficacy Study of Nivolumab Plus Ipilimumab Against Chemotherapy Standard of Care in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649) | Completed | USA | TUR | ROU | POL | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | AUS | ARG | 12 |
NCT02009449 | Phase I | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Pembrolizumab Carboplatin Gemcitabine Docetaxel Pazopanib Capecitabine Paclitaxel Cisplatin Pegilodecakin Nab-paclitaxel | A Phase 1 Study of AM0010 in Patients With Advanced Solid Tumors | Active, not recruiting | USA | 0 |