Therapy Detail

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Therapy Name Fluorouracil + Leucovorin + Oxaliplatin
Synonyms FOLFOX
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
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).
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).

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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
NCT03611556 Phase Ib/II Gemcitabine + Nab-paclitaxel + Oleclumab Durvalumab + Gemcitabine + Nab-paclitaxel + Oleclumab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study Active, not recruiting USA | ESP 2
NCT04793958 Phase III Adagrasib + Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 19
NCT03329248 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin ALT-803 + Avelumab + Bevacizumab + ETBX-011 + GI-4000 Capecitabine + Cyclophosphamide + Nab-paclitaxel QUILT-3.060: Combination Immunotherapy With High-affinity Natural Killer (haNK) in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy. Unknown status USA 0
NCT05052801 Phase III Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101) Recruiting USA | ITA | FRA | ESP | CAN | BEL 22
NCT05253651 Phase III Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03) Recruiting USA 0
NCT04919226 Phase III Fluorouracil + Leucovorin + Oxaliplatin 177Lu-edotreotide Everolimus Capecitabine + Temozolomide Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE) Recruiting USA | FRA | ESP 4
NCT02912559 Phase III Atezolizumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair Recruiting USA | DEU 1
NCT03844750 Phase II Fluorouracil + Leucovorin + Oxaliplatin Pembrolizumab Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery Recruiting USA 0
NCT04008030 Phase III Nivolumab Fluorouracil + Irinotecan + Leucovorin Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab Ipilimumab + Nivolumab A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Patients With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW)) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 16
NCT03530267 Phase II Fluorouracil + Leucovorin + Oxaliplatin Aflibercept + Fluorouracil + Leucovorin Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer (ELDERLY) Recruiting DEU 0
NCT03504397 Phase III Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Fluorouracil + Leucovorin + Oxaliplatin A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 13
NCT03777813 Phase II Fluorouracil + Leucovorin + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer (ARION) 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) Recruiting USA | ITA | FRA | DEU | CAN | BEL 19
NCT04145193 Phase II Durvalumab + Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Monalizumab + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC Withdrawn 0
NCT03694522 Phase II Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT) Completed USA | ITA | FRA | ESP | DEU | BEL 12
NCT02934464 Phase III Paclitaxel + Ramucirumab Fluorouracil + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers (ARMANI) Recruiting ITA 0
NCT03281369 Phase Ib/II Atezolizumab + Cobimetinib Atezolizumab + Cisplatin + Fluorouracil + Tiragolumab Atezolizumab + Cisplatin + Fluorouracil Atezolizumab + Cobimetinib + Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Linagliptin Atezolizumab + PEGPH20 Atezolizumab + BKT140 Paclitaxel + Ramucirumab Cisplatin + Fluorouracil Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Tiragolumab A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) Recruiting USA | FRA | ESP | DEU 6
NCT01792934 Capecitabine + Oxaliplatin Bevacizumab + Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases (ORCHESTRA) Recruiting 2
NCT05062317 Phase II Capecitabine Leucovorin Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases Recruiting USA 0
NCT02923921 Phase III Fluorouracil + Leucovorin + Oxaliplatin + Pegilodecakin Fluorouracil + Leucovorin + Oxaliplatin Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer Completed USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 5
NCT02563002 Phase III Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Pembrolizumab Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177) Active, not recruiting 0
NCT03647969 Phase II Docetaxel + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Ipilimumab + Leucovorin + Nivolumab + Oxaliplatin Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer Active, not recruiting DEU 0


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