C00-C97
Conditions
Interventions
Group 1: (Combination) cancer immunotherapy
Sponsors
National Center for Tumor Diseases (NCT)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - informed consent - Hemoglobin = 8g/dl - Patient age = 18 years - Main diagnosis belongs to C00-C97 according to ICD-10 (2016), Advanced and/or inoperable and/or metastatic (M1 according to TNM 8th edition, AJCC) - Measurable disease according to RECIST 1.1 (14) - Undergoing an immunotherapy in monotherapy or in combination with other cancer-specific therapies. - complete sampling status (blood samples obtained before starting IT (baseline) and 1-7 weeks after therapy initiation) will be included in the final analysis. Patients may not have discontinued immunotherapy between baseline sample and 1-7 weeks sampling. - Complete response evaluation: imaging studies by computed tomography or magnetic resonance imaging performed <6 weeks before start of the immune combination therapy (baseline) and 6-14 weeks after initiation. For inclusion in response analysis, patients may not have discontinued immunotherapy between the imaging studies used for response evaluation. Death from any cause will be considered progressive disease and may be used for response evaluation.
Exclusion criteria
Exclusion criteria: - Adoptive effector cell therapies o Including adoptive T/NK cell therapy, chimeric antigen receptor T cells or NK cells, tumor infiltrating leukocyte infusions) o Not including adoptive dendritic cell transfers (dendritic cell based vaccines)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is radiological response to therapy for which a biomarker-based prediction model will be developed based on the immune cell composition and serum proteome and metabolome of these patients. The model will be trained and validated in the training cohort and tested in the testing cohort. The purpose of the project is to better understand the relationship between therapy response and immune response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the immune cell composition, serum proteome and metabolome under IT and at disease progression, grade =3 adverse events (Common Terminology Criteria of Adverse Events v5.0) and infections, as well as progression-free and overall survival. Select leukocyte subsets will be tested for cytotoxicity, migration, proliferation, metabolic function and cytokine production and differentiation properties in vitro and in xenograft mouse models. The effects of patient serum factors on these properties will also be investigated. | — |
Countries
Germany
Contacts
Public ContactThomas Walle
National Center for Tumor Diseases (NCT)
Outcome results
None listed