levoleucovorin calcium / Generic mfg. - LARVOL DELTA

Tislelizumab (Tisle) combined with POFI (irinotecan, paclitaxel, oxaliplatin, and 5-FU/levoleucovorin) as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma (AGC): Update from a single-arm, open-label phase II trial (SYLT-023). (ASCO-GI 2026) - P1/2 | "Clinical Trial Registration Number: NCT05319639 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase II study of FOLFIRI with low-dose irinotecan plus ramucirumab as second-line treatment in Japanese patients with metastatic colorectal cancer (study rindo). (PubMed, Jpn J Clin Oncol) - "FOLFIRI with low-dose irinotecan plus RAM is a feasible second-line treatment in Japanese patients with mCRC."

Journal • P2 data • Cardiovascular • Colorectal Cancer • Hypertension • Neutropenia • Renal Disease • Solid Tumor • EGFR

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) (clinicaltrials.gov) - P3 | N=863 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2027 ➔ Jun 2026

Trial completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

An open-label, multicenter Phase Ib/II clinical study on the safety, tolerability, pharmacokinetics, and efficacy of QLC5508 injection combined therapy in patients with advanced solid tumors (ChiCTR) - P1/2 | N=414 | Not yet recruiting | Sponsor: Shanghai East Hospital; Qilu Pharmaceutical Co.

New P1/2 trial • Solid Tumor

Tislelizumab combined with POFI (irinotecan, paclitaxel, oxaliplatin, and 5-FU/levoleucovorin) as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma (AGC): Preliminary results from a single-arm, open-label phase II trial (SYLT-023) (ESMO 2025) - P1/2 | "Background A phase I study demonstrated that tislelizumab (Tisle) combined with POFI (irinotecan, paclitaxel, oxaliplatin, 5-fluorouracil/levoleucovorin) was tolerable with promising antitumor activity as first-line treatment for HER2-negative, proficient mismatch repair (pMMR)/microsatellite stable (MSS) advanced gastric/gastroesophageal junction adenocarcinoma (AGC) (Lin R, et al. No new safety signals were identified. Conclusions Tisle + POFI showed promising efficacy and a manageable safety profile as first-line treatment for HER2-negative, pMMR/MSS AGC, warranting further investigation."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

BREAKWATER: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=831 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Vitamins, Vascular Health and Disease. (PubMed, Nutrients) - "Therapeutic strategies to address vascular health and prevent hyperhomocysteinemia in order to preclude follow-on disorders include targeted vitamin supplementation, dietary improvements to ensure a sufficient intake of bioavailable nutrient forms, and, in certain clinical contexts, the use of active L-methylfolate or levoleucovorin (a drug product) to bypass metabolic conversion issues. These evidence-based interventions aim to restore endothelial homeostasis, slow disease progression, and improve patient outcomes across a variety of disorders linked to poor vascular health."

Journal • Review • Age-related Macular Degeneration • Alzheimer's Disease • Autism Spectrum Disorder • Cardiovascular • CNS Disorders • Dementia • Genetic Disorders • Macular Degeneration • Metabolic Disorders • Ophthalmology • Peripheral Arterial Disease • Retinal Disorders • Vascular Neurology

KEYMAKER-U06 Substudy 06E: Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) (clinicaltrials.gov) - P1/2 | N=228 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2031 ➔ Jan 2032 | Trial primary completion date: Feb 2031 ➔ Jan 2032

Enrollment open • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

LIGHTBEAM-02A: A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A) (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=130 ➔ 180

Enrollment change • Biliary Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

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) (clinicaltrials.gov) - P3 | N=863 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Jan 2027 ➔ May 2025

Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

Electronic Patient-Reported Outcome Quality of Life Score in Japanese Patients With Pancreatic Cancer on Second-Line Chemotherapy: A Multicenter Observational Study. (PubMed, Cancer Med) - "Patients' QoL score assessment over time by ePRO revealed QoL score trends, which emphasized the importance of QoL management outside of hospital visits for each chemotherapy."

HEOR • Journal • Observational data • Oncology • Pancreatic Cancer • Solid Tumor

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors (clinicaltrials.gov) - P2 | N=53 | Active, not recruiting | Sponsor: Taiho Oncology, Inc. | Trial primary completion date: Jul 2025 ➔ Mar 2026

Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • PD-L1

A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) (clinicaltrials.gov) - P3 | N=477 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor • KRAS

A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) (clinicaltrials.gov) - P3 | N=477 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2031 ➔ Oct 2030

Trial completion date • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor • KRAS

An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: National Cancer Center Hospital East | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

NuTide:303: NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=19 | Terminated | Sponsor: NuCana plc | N=91 ➔ 19 | Trial completion date: Dec 2025 ➔ May 2025 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ May 2025; The NuTide:303 study was terminated at NuCana's discretion due to refinement of the pipeline strategy. The overall risk benefit assessment of NUC-3373 remains positive and future NUC-3373 studies are under consideration.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Classical Hodgkin Lymphoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Hormone Receptor Positive Breast Cancer • Lung Cancer • Lymphoma • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Pleural Mesothelioma • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • MSI

Effect of pretreatment vascular endothelial growth factor inhibitor use on the safety and efficacy of trifluridine/tipiracil plus bevacizumab in patients with metastatic colorectal cancer. (PubMed, Int J Clin Oncol) - "Different pretreatment VEGF inhibitors did not affect the efficacy and safety of FTD/TPI plus BEV."

Journal • Colorectal Cancer • Hematological Disorders • Neutropenia • Oncology • Renal Disease • Solid Tumor

Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced: a Multicenter, Open-label, Randomized Phase III Studyunresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=269 | Recruiting | Sponsor: Fujian Cancer Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

LIBImAb: Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB (clinicaltrials.gov) - P3 | N=280 | Recruiting | Sponsor: Azienda USL Reggio Emilia - IRCCS | Trial completion date: Apr 2024 ➔ May 2026 | Trial primary completion date: Apr 2023 ➔ May 2025

Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF

An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=26 | Not yet recruiting | Sponsor: National Cancer Center Hospital East

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Drug-eluting beads loaded with irinotecan-transarterial chemoembolization (DEBIRI-TACE) combined with hepatic artery infusion chemotherapy and regorafenib in colorectal liver metastases refractory to second-line and above standard systemic therapy: A single-center, phase II clinical trial (DREAM). (ASCO 2025) - P=N/A | "All of the patients received at least once DEBIRI-TACE and FOLFOX-HAIC (Oxaliplatin 85mg/m2 2h + Calcium Levofolinate 200mg/m2 2h + Fluorouracil 2400mg/m2 46h) plus oral regorafenib 80/120/160 mg once daily during weeks 1-3 of each 4-week cycle until disease progression or unacceptable toxicity... DEBIRI-TACE combined with HAIC and regorafenib is feasible, safe and shows promising efficacy in treating the patients with CRLM, even after second-line and above systemic chemotherapy."

Clinical • P2 data • Hepatology • Liver Failure • Oncology • Pain • KRAS

Long-term safety and efficacy of sotorasib plus panitumumab and FOLFIRI for previously treated KRAS G12C-mutated metastatic colorectal cancer (mCRC): CodeBreaK 101 (phase 1b). (ASCO 2025) - P1, P3 | "Discontinuation of sotorasib, panitumumab, or FOLFIRI (5-FU, irinotecan, or leucovorin/levoleucovorin) due to AEs was observed in 1 (2.5%), 1 (2.5%), and 16 (40.0%) patients, respectively... Sotorasib plus panitumumab and FOLFIRI showed promising long-term safety and efficacy in pretreated KRAS G12C-mutated mCRC. AEs were consistent with the safety profile of the drugs administered. The ongoing phase 3 study, CodeBreaK 301 (NCT06252649), aims to evaluate this combination against standard of care in first-line patients with KRAS G12C-mutated mCRC."

Clinical • Metastases • P1 data • Colorectal Cancer • Dental Disorders • Dermatitis • Dermatology • Immunology • Oncology • Solid Tumor • Stomatitis • KRAS

A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) (clinicaltrials.gov) - P3 | N=477 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor • KRAS

LIGHTBEAM-02A: A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A) (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Dec 2028 ➔ Oct 2029 | Trial primary completion date: Dec 2028 ➔ Oct 2029

Monotherapy • Trial completion date • Trial primary completion date • Biliary Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Comparison of dose rounding and drug vial optimization for reducing anticancer drug waste. (PubMed, J Oncol Pharm Pract) - " Patients who received bevacizumab, ramucirumab, gemcitabine, or levofolinate between January and December 2023 at Kanagawa Prefectural Ashigarakami Hospital (Ashigarakami) and Ogaki Municipal Hospital (Ogaki) were included in this study. Compared with DVO, DR is not influenced by the number of patients treated or the volume of anticancer drugs administered, making it feasible for implementation across a wide range of institutions and a highly effective strategy for minimizing waste. DR should be advocated as a key approach for reducing drug costs in Japan in the future."

Journal • Oncology