levoleucovorin calcium / Generic mfg. - LARVOL DELTA

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) (clinicaltrials.gov) - P3 | N=895 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

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

Exploratory biomarkers for oxaliplatin-induced nivolumab responsiveness in metastatic microsatellite-stable colorectal cancer (Nature) - "The median tumour mutational burden (TMB; in mutations/megabase) was 8 (range, 1–13). The experimental-arm patients with TMB ≥9 or BRAF-V600E mutation (n = 17) achieved median PFS of 19.8 months (95% confidence interval, 11.3–28.3), longer (p = 0.0090) than experimental-arm patients with TMB < 9 not BRAF-V600E (n = 19) and control-arm patients with either TMB and BRAF status combination (n = 31). With TMB ≥9 or BRAF-V600E and normal, non-inflammatory level of C-reactive protein when starting nivolumab (n = 11), median PFS was 35.0 months (95% confidence interval, 6.8–63.0; p < 0.0001)."

P2 data • pMMR • Colorectal Adenocarcinoma • Colorectal Cancer

A clinical study of MK-1084 with targeted therapy and chemotherapy in people with colorectal cancer (MK-1084-012). (clinicaltrialsregister.eu) - P2/3 | N=141 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2/3 trial • Colorectal Cancer • Oncology • Solid Tumor • KRAS

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer (clinicaltrials.gov) - P3 | N=614 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

UC-GIG-2408: Study evaluating two treatment strategies for rectal cancer in patients ?75 years old (clinicaltrialsregister.eu) - P2/3 | N=160 | Not yet recruiting | Sponsor: Unicancer

New P2/3 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

UC-GIG-2411: Testing ivonescimab in combination with standard chemotherapy in advanced or metastatic gastric and gastroesophageal adenocarcinoma patients (clinicaltrialsregister.eu) - P1/2 | N=88 | Recruiting | Sponsor: Unicancer

New P1/2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

OrigAMI-2: A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2032 ➔ Jan 2032

Trial completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS • NRAS • RAS

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 | "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. 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 • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

A Study to Confirm the Safety of ASP3082, and if it Delays Tumor Growth in People With Pancreatic Cancer, When Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies (clinicaltrials.gov) - P3 | N=614 | Not yet recruiting | Sponsor: Astellas Pharma Global Development, Inc.

New P3 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Comparative Cost-Effectiveness Analysis of Multiple First-Line Treatments for HER2-Negative Unresectable Advanced or Recurrent Gastric Cancer in Japan. (PubMed, Pharmacoecon Open) - "At a willingness-to-pay threshold of USD 100,000/QALY (Japan's HTA upper reference), SOX was identified as the most cost-effective first-line treatment for HER2-negative unresectable advanced or recurrent GC in Japan."

HEOR • Journal • Gastric Cancer • Oncology • Solid Tumor • HER-2

Safety and Efficacy of Concomitant Administration of Nanoliposomal Irinotecan + 5-Fluorouracil/Levo-Leucovorin for Pancreatic Cancer. (PubMed, Cancer Rep (Hoboken)) - "Concomitant administration of Levo-LV with nal-IRI may not increase adverse events or impact efficacy compared to sequential administration."

Journal • Oncology • Pancreatic Cancer • Solid Tumor

KEYMAKER-06C: Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2029 ➔ Sep 2029 | Trial primary completion date: Jan 2027 ➔ Sep 2029

Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • ERBB3 • HER-2

LAP-NET1: Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: University Hospital, Grenoble | Active, not recruiting ➔ Completed

Trial completion • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CA 19-9

Bevacizumab plus FOLFIRI after failure of platinum-etoposide first-line chemotherapy in patients with advanced neuroendocrine carcinoma (PRODIGE 41-BEVANEC): a randomised, multicentre, non-comparative, open-label, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "The addition of bevacizumab did not seem to increase the benefit of FOLFIRI with regard to overall survival. FOLFIRI could be considered as a standard second-line treatment in patients with gastroenteropancreatic neuroendocrine carcinoma."

Journal • Metastases • P2 data • Cardiovascular • Endocrine Cancer • Hematological Disorders • Ischemic stroke • Neuroendocrine Tumor • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

Oxaliplatin Added to Fluoropyrimidine/Bevacizumab as Initial Therapy for Unresectable Metastatic Colorectal Cancer in Older Patients: A Multicenter, Randomized, Open-Label Phase III Trial (JCOG1018). (PubMed, J Clin Oncol) - "No benefit of adding OX to FP + BEV as first-line treatment was demonstrated in older patients with MCRC. FP + BEV is recommended for this population."

Journal • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Tislelizumab (Tisle) combined with POFI (irinotecan, paclitaxel, oxaliplatin and 5-FU/levoleucovorin) as first-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma (AGC): OS analysis results of the SYLT-023. (ASCO-GI 2025) - P1/2 | "The combination of Tisle + XELOX/FP is a first-line treatment of AGC in China... Tisle+POFI was well tolerated and showed preliminary antitumor activity in AGC. A phase II study is ongoing."

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

KEYMAKER-U06 Substudy 06E: Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) (clinicaltrials.gov) - P1/2 | N=298 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=228 ➔ 298

Enrollment change • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

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) - P3 | "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."

Journal • Metastases • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Prognostic value of the modified Glasgow Prognostic Score in patients with metastatic pancreatic cancer: An exploratory analysis of JCOG1611. (ASCO-GI 2026) - "In this exploratory analysis of JCOG1611, a randomized phase II/III trial comparing gemcitabine plus nab-paclitaxel (GnP), modified 5-fluorouracil, levofolinate, irinotecan, and oxaliplatin (mFFX), and S-1, irinotecan, and oxaliplatin (S-IROX), we evaluated whether mGPS can predict prognosis of patients with metastatic pancreatic cancer. mGPS showed a trend toward prognostic significance in patients with metastatic pancreatic cancer treated with GnP or mFFX, and suggested potential prognostic relevance in those treated with S-IROX."

Clinical • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CRP

A fully validated HPLC-UV detection method associated with color variation control for the evaluation of the long term stability of calcium levofolinate solutions in polyolefin infusion bags and in polypropylene syringes in dose banding conditions. (PubMed, J Oncol Pharm Pract) - "Microbiological tests performed were negative.ConclusionsA simple, accurate and stability-indicating HPLC method was developed to determine calcium levofolinate concentrations in dose-banding conditions associated with color variation investigation. This study supports a centralized production of calcium levofolinate in accordance with the studied conditions."

Journal

Successful re-administration after nano-liposomal irinotecan-induced severe hypersensitivity reaction: a case report. (PubMed, J Pharm Health Care Sci) - "The novelty of this report lies in presenting, for the first time, the detailed course and process by which treatment was successfully continued in a patient experiencing severe HSR upon initial nal-IRI administration, through enhanced supportive care tailored to the characteristics of the drug and stepwise dose adjustment."

Journal • Allergy • CNS Disorders • Epilepsy • Immunology • Oncology • Pancreatic Cancer • Solid Tumor

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 primary completion date: Aug 2029 ➔ Mar 2029

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

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