Therapy Detail

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Therapy Name Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Fluorouracil Adrucil 5-FU Chemotherapy - Antimetabolite 13 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 13 Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554).
Oxaliplatin Eloxatin Diaminocyclohexane Oxalatoplatinum Chemotherapy - Platinum 6 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 135 PD-L1/PD-1 antibody 78 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, 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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01985763 Phase Ib/II Genistein Bevacizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Genistein in Treatment of Metastatic Colorectal 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 6
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
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
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) Active, not recruiting USA | CAN 27
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) Active, not recruiting USA 0
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
NCT02319018 Phase I Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Alisertib Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors Completed 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 7
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
NCT01652976 Phase II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Dasatinib Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma Completed USA 0
NCT01327612 Phase II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Ganitumab Bevacizumab Conatumumab Open Label Extension Study of Conatumumab and AMG 479 Completed USA 2
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
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
NCT01747551 Phase II Aflibercept Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer Completed USA 0
NCT02921256 Phase II Veliparib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Capecitabine + Veliparib Capecitabine Veliparib and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer Active, not recruiting USA 1
NCT01489865 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Veliparib ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer Unknown status 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
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
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 | CAN 22
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
NCT03488667 Phase II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Perioperative mFOLFOX Plus Pembrolizumab in Gastroesophageal Junction (GEJ) and Stomach Adenocarcinoma Recruiting USA 0
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
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 15
NCT02375672 Phase II Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer 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
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
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 Suspended USA 0
NCT01516216 Phase II Bevacizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Study of Vitamin D in Untreated Metastatic Colorectal Cancer Completed 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
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
NCT01571024 Phase I Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Buparlisib BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer Completed USA 0
NCT02625610 Phase III Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Avelumab Capecitabine + Oxaliplatin Avelumab in First-Line Gastric Cancer (JAVELIN Gastric 100) Completed USA | CAN 15
NCT01666730 Phase II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Metformin Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic 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 10
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 3
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) Active, not recruiting USA | CAN 0
NCT01206530 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Bevacizumab Hydroxychloroquine FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer 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


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