Therapy Detail

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 10 Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth (NCI Drug Dictionary). Fluorouracil is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov).
Leucovorin Wellcovorin Calcium folinate|Calcium citrovorum factor|folinic acid Chemotherapy - Antimetabolite 10 Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (NCI Drug Dictionary).
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 (NCI Drug Dictionary). Eloxatin (oxaliplatin) is FDA approved for colorectal cancer (FDA.gov).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 99 PD-L1/PD-1 antibody 51 Keytruda (pembrolizumab) is an antibody against PD-1, resulting in activation of T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved for use in patients with melanoma, small cell lung cancer, HNSCC, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, hepatocellular carcinoma, Merkel cell carcinoma, MSI-H or dMMR solid tumors, PD-L1 expressing NSCLC, gastric cancer, GEJ adenocarcinoma, and cervical cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, in combination with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, and in combination with axitinib for renal cell carcinoma (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
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 Recruiting
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) Completed
NCT02625610 Phase III Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Avelumab Capecitabine + Oxaliplatin Avelumab in First-Line Gastric Cancer (JAVELIN Gastric 100) Active, not recruiting
NCT02319018 Phase I Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Alisertib Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors Completed
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
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 Active, not recruiting
NCT01516216 Phase II Bevacizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Study of Vitamin D in Untreated Metastatic Colorectal Cancer Active, not recruiting
NCT02921256 Phase II Veliparib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Capecitabine + Veliparib Capecitabine Veliparib and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer Recruiting
NCT02046538 Phase II Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Aflibercept Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer Withdrawn
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
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
NCT02545504 Phase III Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab GS-5745 GS-5745 With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Completed
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
NCT01985763 Phase Ib/II Genistein Bevacizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Genistein in Treatment of Metastatic Colorectal Cancer Completed
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 Active, not recruiting
NCT02268825 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Pembrolizumab Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers Terminated
NCT01803282 Phase I GS-5745 Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Carboplatin + Pemetrexed Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Carboplatin + Paclitaxel Paclitaxel Bevacizumab Safety and Tolerability Study in Solid Tumors Completed
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
NCT01652976 Phase II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Dasatinib Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma Active, not recruiting
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 Active, not recruiting
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
NCT01666730 Phase II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Metformin Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer Completed
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 Completed
NCT02375672 Phase II Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer Active, not recruiting
NCT01747551 Phase II Aflibercept Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer Completed
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) Recruiting
NCT01327612 Phase II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Ganitumab Bevacizumab Conatumumab Open Label Extension Study of Conatumumab and AMG 479 Active, not recruiting
NCT01206530 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Bevacizumab Hydroxychloroquine FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer Completed
NCT01571024 Phase I Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Buparlisib BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer Completed
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
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
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
NCT01489865 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Veliparib ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer Active, not recruiting
NCT02912559 Phase III Atezolizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair or Microsatellite Instability Recruiting
NCT03488667 Phase II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Perioperative mFOLFOX Plus Pembrolizumab in Gastroesophageal Junction (GEJ) and Stomach Adenocarcinoma Recruiting
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
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
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 Active, not recruiting


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