^
4d
LAP-NET1: Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P1, N=52, Active, not recruiting, University Hospital, Grenoble | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • NP137 • levoleucovorin calcium
12d
Enrollment open • Trial completion date • Metastases
|
BRAF (B-raf proto-oncogene)
|
Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • Rybrevant (amivantamab-vmjw) • leucovorin calcium • levoleucovorin calcium
27d
Trial completion date • Combination therapy • Metastases
|
Opdivo (nivolumab) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • BMS-986310 • levoleucovorin calcium
1m
EPOC2001: An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib with Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients with Gastric Cancer (clinicaltrials.gov)
P2, N=43, Active, not recruiting, National Cancer Center Hospital East | Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2025 --> Aug 2026
Enrollment closed • Trial primary completion date
|
Keytruda (pembrolizumab) • docetaxel • 5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • levoleucovorin calcium
1m
An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
P1, N=32, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Trial completion date: May 2025 --> Dec 2026 | Trial primary completion date: May 2025 --> Dec 2026
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
2ms
New P3 trial • Metastases
|
BRAF (B-raf proto-oncogene)
|
Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • Rybrevant (amivantamab-vmjw) • leucovorin calcium • levoleucovorin calcium
2ms
A case of MSI-high pancreatic body-tail cancer successfully treated with radical resection after pembrolizumab. (PubMed, Clin J Gastroenterol)
She underwent six courses of gemcitabine + nab-paclitaxel as first-line chemotherapy, 12 courses of oxaliplatin + irinotecan + levofolinate + fluorouracil as second-line chemotherapy, and five courses of albumin-suspended irinotecan + levofolinate + fluorouracil as third-line chemotherapy. She is currently alive without recurrence at 18 months postoperatively. It is extremely rare for patients with unresectable and MSI-high pancreatic cancer to successfully undergo conversion surgery after pembrolizumab treatment.
Journal
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Keytruda (pembrolizumab) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • levoleucovorin calcium
3ms
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours (clinicaltrials.gov)
P1/2, N=91, Recruiting, NuCana plc | Trial primary completion date: Aug 2024 --> Jan 2025
Trial primary completion date • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
Keytruda (pembrolizumab) • docetaxel • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
3ms
LAP-NET1: Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P1, N=52, Recruiting, University Hospital, Grenoble | Trial completion date: Nov 2025 --> Mar 2027 | Trial primary completion date: Nov 2024 --> Mar 2026
Trial completion date • Trial primary completion date • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • NP137 • levoleucovorin calcium
3ms
ONO-7913-04: The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer (clinicaltrials.gov)
P1, N=65, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Trial completion date: Jan 2025 --> Dec 2027 | Trial primary completion date: Jan 2025 --> Dec 2027
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
4ms
A real-world survey on expensive drugs used as first-line chemotherapy in patients with HER2-negative unresectable advanced/recurrent gastric cancer in the stomach cancer study group of the Japan clinical oncology group. (PubMed, Jpn J Clin Oncol)
The regimens with >20-fold cost of conventional chemotherapy were used as first-line chemotherapy in two-thirds of patients and more than half even in the elderly population with HER2-negative AGC. This finding is important for future health economic studies on drug cost-efficacy.
Journal • Real-world evidence • Real-world • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • Teysuno (gimeracil/oteracil/tegafur) • levoleucovorin calcium
4ms
Enrollment open • Metastases
|
Keytruda (pembrolizumab) • 5-fluorouracil • capecitabine • oxaliplatin • sacituzumab tirumotecan (MK-2870) • levoleucovorin calcium
5ms
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer (clinicaltrials.gov)
P1, N=40, Active, not recruiting, Ono Pharmaceutical Co. Ltd
New P1 trial • Combination therapy • Metastases
|
Opdivo (nivolumab) • Avastin (bevacizumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • BMS-986310 • levoleucovorin calcium
5ms
Enrollment closed • Metastases
|
5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
5ms
New P1 trial • Combination therapy • Metastases
|
Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
5ms
New P1 trial • Combination therapy • Metastases
|
Opdivo (nivolumab) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • BMS-986310 • levoleucovorin calcium
5ms
New P1 trial • Combination therapy • Metastases
|
Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
6ms
Enrollment closed • Metastases
|
BRAF (B-raf proto-oncogene)
|
Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • capecitabine • Braftovi (encorafenib) • oxaliplatin • irinotecan • leucovorin calcium • Khapzory (levoleucovorin) • levoleucovorin calcium
6ms
A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A) (clinicaltrials.gov)
P1/2, N=130, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1/2
Enrollment open • Phase classification • Combination therapy
|
5-fluorouracil • sacituzumab tirumotecan (MK-2870) • levoleucovorin calcium
6ms
New P1/2 trial • Metastases
|
Keytruda (pembrolizumab) • 5-fluorouracil • capecitabine • oxaliplatin • sacituzumab tirumotecan (MK-2870) • levoleucovorin calcium
7ms
New P2 trial
|
5-fluorouracil • sacituzumab tirumotecan (MK-2870) • levoleucovorin calcium
8ms
Enrollment closed
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • levoleucovorin calcium
8ms
Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder (clinicaltrials.gov)
P2, N=56, Active, not recruiting, Southwest Autism Research & Resource Center | Recruiting --> Active, not recruiting | N=134 --> 56 | Trial primary completion date: Jan 2025 --> Apr 2024
Enrollment closed • Enrollment change • Trial primary completion date
|
leucovorin calcium • levoleucovorin calcium
9ms
NuTide:302: A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment (clinicaltrials.gov)
P1/2, N=107, Completed, NuCana plc | Recruiting --> Completed | N=225 --> 107 | Trial completion date: Nov 2023 --> Mar 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600 • KRAS wild-type • RAS wild-type
|
Avastin (bevacizumab) • Erbitux (cetuximab) • Vectibix (panitumumab) • oxaliplatin • irinotecan • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
10ms
Enrollment change • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • Lytgobi (futibatinib) • irinotecan • levoleucovorin calcium
11ms
Efficacy and safety of neoadjuvant sintilimab in combination with FLOT chemotherapy in patients with HER2-negative locally advanced gastric or gastroesophageal junction adenocarcinoma: an investigator-initiated, single-arm, open-label, phase II study. (PubMed, Int J Surg)
The study demonstrated an encouraging efficacy and manageable safety profile of neoadjuvant sintilimab plus FLOT in HER2-negative locally advanced G/GEJ cancer, which suggested a potential therapeutic option for this population.
P2 data • Journal • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
HER-2 negative
|
docetaxel • 5-fluorouracil • Tyvyt (sintilimab) • oxaliplatin • leucovorin calcium • levoleucovorin calcium
11ms
CLIMB: Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab (clinicaltrials.gov)
P2, N=20, Completed, Asan Medical Center | Active, not recruiting --> Completed
Trial completion
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • 5-fluorouracil • oxaliplatin • levoleucovorin calcium
11ms
New P2 trial • Metastases
|
5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
1year
LAP-NET1: Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P1, N=52, Recruiting, University Hospital, Grenoble | Not yet recruiting --> Recruiting | Trial completion date: Nov 2024 --> Nov 2025
Enrollment open • Trial completion date • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • NP137 • levoleucovorin calcium
1year
Trial completion date • Trial primary completion date
|
Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • leucovorin calcium • levoleucovorin calcium
1year
Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer (clinicaltrials.gov)
P2, N=20, Recruiting, Fujian Cancer Hospital | Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Nov 2023
Enrollment open • Trial initiation date • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Kaitanni (cadonilimab) • levoleucovorin calcium
1year
Ramucirumab plus FOLFIRI as second-line treatment for patients with RAS wild-type metastatic colorectal cancer previously treated with anti-EGFR antibody: JACCRO CC-16. (PubMed, ESMO Open)
Our study demonstrated prospectively that RAM plus FOLFIRI is an effective second-line treatment after anti-EGFR antibody-containing first-line therapy in RAS wild-type and left-sided mCRC. Furthermore, the results were similar for patients who were previously treated with triplet regimen.
Journal • Metastases
|
RAS (Rat Sarcoma Virus)
|
RAS wild-type
|
Erbitux (cetuximab) • 5-fluorouracil • Cyramza (ramucirumab) • irinotecan • leucovorin calcium • levoleucovorin calcium
1year
Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder (clinicaltrials.gov)
P2, N=134, Recruiting, Southwest Autism Research & Resource Center | Active, not recruiting --> Recruiting | Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Jul 2023 --> Jan 2025
Enrollment open • Trial completion date • Trial primary completion date
|
leucovorin calcium • levoleucovorin calcium
over1year
High vs. low-dose leucovorin in regimens with fluorouracil in colorectal cancer therapy. (PubMed, Ceska Slov Farm)
In 17 cases, the departments for the preparation of cytostatics in the Czech Republic had to accept restrictions on administering the full dose of leucovorin. These restrictions consisted of reducing the dose of the injectable form of leucovorin, changing the chemotherapy regimen, administering the oral form of calcium folinate, forcing a therapeutic break, or a combination of these approaches.
Journal
|
5-fluorouracil • leucovorin calcium • levoleucovorin calcium
over1year
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors (clinicaltrials.gov)
P2, N=26, Recruiting, Taiho Oncology, Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • Lytgobi (futibatinib) • levoleucovorin calcium
over1year
Parallel administration of nanoliposomal irinotecan and levo-leucovorin for pancreatic cancer. (PubMed, BMC Cancer)
The parallel administration of nal-IRI and Levo-LV is clinically safe and not inferior in efficacy. Moreover, parallel administration may offer convenience to patients and healthcare workers by reducing administration time.
Journal
|
5-fluorouracil • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
over1year
New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • Lytgobi (futibatinib) • levoleucovorin calcium
over1year
NuTide:302: A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment (clinicaltrials.gov)
P1/2, N=225, Recruiting, NuCana plc | Trial completion date: Jun 2023 --> Nov 2023 | Trial primary completion date: Jun 2023 --> Nov 2023
Trial completion date • Trial primary completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600 • KRAS wild-type • RAS wild-type
|
Avastin (bevacizumab) • Erbitux (cetuximab) • Vectibix (panitumumab) • oxaliplatin • irinotecan • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
over1year
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours (clinicaltrials.gov)
P1/2, N=91, Recruiting, NuCana plc | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
Keytruda (pembrolizumab) • docetaxel • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
over1year
Levoleucovorin inhibits LOXL2 (lysyl oxidase like-2) to control breast cancer proliferation: a repurposing approach. (PubMed, J Biomol Struct Dyn)
Levoleucovorin controlled cell proliferations in MDM-MB 231 and MCF-7 cells with GI50 values of 55.91 μM and 79.20 μM respectively. Further, a dose dependent inhibition of cancer cell migration was noted along with apoptosis induction in these cells with levoleucovorin treatment.Communicated by Ramaswamy H. Sarma.
Journal
|
levoleucovorin calcium
over1year
Posterior reversible encephalopathy syndrome triggered by FLOT (5-fluorouracil, oxaliplatin, docetaxel, and calcium levofolinate) chemotherapy and thrombocytopenia (docetaxel and cisplatin) chemotherapy. (PubMed, J Oncol Pharm Pract)
Posterior reversible encephalopathy syndrome is a clinical and imaging syndrome characterized by endothelial dysfunction, blood-brain barrier disruption, and vasogenic edema. This is the first report that posterior reversible encephalopathy syndrome is caused by a thrombocytopenia regimen, and our case highlights the pathogenic role of a thrombocytopenia regimen in posterior reversible encephalopathy syndrome. However, the association between the thrombocytopenia regimen and previous fluorouracil, leucovorin, oxaliplatin, and docetaxel regimens needs further study.
Journal
|
cisplatin • docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • levoleucovorin calcium
over1year
Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. (PubMed, Lancet)
Targeting CLDN18.2 with zolbetuximab significantly prolonged progression-free survival and overall survival when combined with mFOLFOX6 versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Zolbetuximab plus mFOLFOX6 might represent a new first-line treatment in these patients.
P3 data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
|
HER-2 negative • CLDN18.2 positive • EGFR positive
|
5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb) • levoleucovorin calcium