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|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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ATM W1058* ATM S1993fs gastroesophageal adenocarcinoma predicted - sensitive Fluorouracil + Leucovorin + Oxaliplatin Case Reports/Case Series Actionable In a retrospective analysis, treatment with the combination of Adrucil (fluorouracil), Wellcovorin (leucovorin), and Eloxatin (oxaliplatin) resulted in a partial response and a progression-free survival of 7.2 months in a patient with gastroesophageal adenocarcinoma harboring ATM W1058* and S1993fs (PMID: 37129948). 37129948

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05476796 Phase II Fluorouracil + Leucovorin + Oxaliplatin Nivolumab + Oxaliplatin + Trifluridine-tipiracil hydrochloride Oxaliplatin + Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer (LOGICAN) Recruiting FRA 0
NCT06333314 Phase II Dostarlimab-gxly Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Doxorubicin Gemcitabine Gemcitabine + Nab-paclitaxel Doxorubicin + Trabectedin Fluorouracil + Leucovorin + Oxaliplatin Cisplatin + Etoposide Cisplatin + Gemcitabine Cisplatin + Doxorubicin + Etoposide Capecitabine + Oxaliplatin Doxorubicin + Ifosfamide Carboplatin + Etoposide Carboplatin + Paclitaxel Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin Mitotane Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI (Pan-MSI-ACSE) Not yet recruiting FRA 0
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) Completed 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
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
NCT05713838 Phase II Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Durvalumab Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery Recruiting DEU 0
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) Unknown status ITA 0
NCT05870800 Phase II Atezolizumab + Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Neoadjuvant Chemoimmunotherapy for Resectable Non-Metastatic Proficient Mismatch Repair (PMMR) Colon Cancer Not yet recruiting USA 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) Active, not recruiting USA | GBR | ESP | AUS 3
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 | ITA | GBR | FRA | DEU | CAN | BEL 20
NCT03329248 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin Avelumab + Bevacizumab + ETBX-011 + GI-4000 + Nogapendekin alfa inbakicept 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. Active, not recruiting USA 0
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
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 | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 3
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
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) Completed DEU 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 | NLD | ITA | GBR | FRA | ESP | DEU | AUS 2
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 | AUS 30
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 15
NCT05062889 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients (ERASE-CRC) Recruiting ITA 0
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) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 20
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 NLD | GBR 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 Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW) Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 13
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 | GBR | FRA | ESP | DEU | BEL | AUS 10
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 Active, not recruiting USA | DEU 1
NCT05564377 Phase II Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Olaparib Olaparib + Selumetinib Alpelisib + Olaparib Neratinib Neratinib + Palbociclib Fluorouracil + Leucovorin + Oxaliplatin Ipatasertib + Paclitaxel Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial Recruiting USA 1
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 Completed USA | ESP | AUS 1
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
NCT05564403 Phase II Fluorouracil + Leucovorin + Oxaliplatin Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) Recruiting USA 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 | GBR | FRA | ESP | DEU | CAN | BEL | AUS 11


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