neoplasmata maligne en niet-gespecificeerd van de borst, maagdarmstelsel, lever- en galwegen en endocriene organen mesothelin expressing advanced or recurrent malignancies multi-indication
Conditions
Interventions
Monotherapy indications: NSCLC adenocarcinoma, TNBC, gastric adenocarcinoma
including GEJ cancer, thymic carcinoma
a) Anetumab ravtansine 6.5 mg/kg every 21 days (1 cycle)
Chemotherapy combination i
cancer
mesothelin overexpression
solid tumors
Sponsors
Bayer
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Availability of tumor tissue for mesothelin expression testing - Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria) - At least one measurable lesion according to either RECIST 1.1 or ITMIG modified RECIST 1.1 as applicable - Adequate bone marrow, liver, renal and coagulation function - LVEF * 50% of the lower limit of normal (LLN) according to local institutional ranges - ECOG 0 or 1 - Availability of additional tumor tissue for further biomarker analysis
Exclusion criteria
Exclusion criteria: - More than one prior anti-tubulin/microtubule agent - Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition - Symptomatic CNS metastases and/or carcinomatous meningitis - Contraindication to both CT and MRI contrast agents - Active hepatitis B or C infection - Pregnant or breast-feeding patients - Tumor type specific exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Maximum tolerated dose (MTD) of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine in patients with mesothelin-expressing cholangiocarcinoma and pancreatic adenocarcinoma. Timeframe of Measurement: At least 3 weeks after the last patient starts treatment. 2) Objective response rate (ORR) of anetumab ravtansine for monotherapy and combination therapy in mesothelin expressing advanced solid tumors. Timeframe of measurement: 18 weeks after last patient starts treatment. Durable Disease Control Rate (DDCR) as dual primary variables in pancreatic and gastric cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number of serious and non-serious adverse events (AEs) of the respective anetumab ravtansine monotherapy or combination treatments in the respective indications of mesothelin expressing advanced solid tumors. Timeframe of Measurement: 18 weeks after last patient starts treatment. 2) Disease control rate (DCR). Timeframe of Measurement: 18 weeks after last patient starts treatment. 3) Duration of response (DOR). Timeframe of Measurement: Approximately 24 months after last patient starts treatment. 4) Durable response rate (DRR). Timeframe of Measurement: Approximately 24 months after last patient starts treatment. 5) Progression free survival (PFS). Timeframe of Measurement: Approximately 24 months after last patient starts treatment. | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Korea (the Republic of), Netherlands, Singapore, Spain, Switzerland, United Kingdom, United States of America
Outcome results
None listed