advanced MSI-H colorectal cancer MedDRA version: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: micoryx
Pharmaceutical Form: Powder for solution for injection
Sponsors
Oryx GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically confirmed, surgically resected colorectal cancer of advanced stage (UICC stage III/UICC stage IV). This comprises patients with lymph node metastases (UICC stage III), metastasis to one distant organ (UICC IV, M1a), to more than one distant organ, or patients with peritoneal carcinosis (M1b) •Detection of high level microsatellite instability (MSI-H) in the resected tumor sample according to the international consensus criteria (multiplex PCR of quasi-monomorphic microsatellite markers BAT25, BAT26, CAT25), see Appendix 1. •Prior adjuvant standard therapy (chemotherapy with 5-fluorouracil/folinic acid, oxaliplatin, irinotecan or combinations of these) OR Prior palliative standard therapy in the first, second and third line (chemotherapy with 5-fluorouracil, oxaliplatin, irinotecan or combinations of these and/or treatment with anti-EGFR antibodies cetuximab or panitumumab alone or in combination with chemotherapy) with either complete or partial remission, stable disease, or disease progression under therapy; OR Patient has refused adjuvant or palliative standard therapy (chemotherapy using 5-fluorouracil, oxaliplatin, or regimens combining these). •Expected survival of at least six months. •Full recovery from surgery or radiation therapy •ECOG performance status 0, 1 or 2. •The following laboratory results: Neutrophil count > 1.5 x 109/L Lymphocyte count > 0.5 x 109/L Platelet count > 100 x 109/L Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: •Prior treatment with FSPs AIM2(-1), HT001(-1) and TAF1B(-1) •Clinically significant heart disease (NYHA Class IV). •Other serious illnesses, eg, serious infections requiring antibiotics or bleeding disorders. •History of immunodeficiency disease or autoimmune disease. •Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available. •HBV, HCV or HIV positivity. •Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry •Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted. •Participation in any other clinical trial •Pregnancy or lactation. •Women of childbearing potential who are not using a medically acceptable means of contraception. Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). •Psychiatric or addictive disorders that may compromise the ability to give informed consent. •Lack of availability of a patient for immunological and clinical follow-up assessment. •Brain metastases (symptomatic and non-symptomatic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I Part: Safety of the vaccine Phase IIa Part: Immune response against the FSP mix;Secondary Objective: Phase I Part: Immune response against the FSP mix Tumor response Phase IIa Part: Safety of the vaccine Tumor response ;Primary end point(s): • Safety of the vaccine administration as assessed by the number and severity of adverse events categorized according to CTC criteria version 4.0 and the probability of the induction of immune tolerance. Immune tolerance is defined as a significant and sustained decline of antigen-specific cellular immune responses after vaccination (weeks 9, 17 and 25, or weeks 17 and 25) compared to the antigen-specific cellular immune response measured before vaccination (week 1), as assessed by IFN-gamma ELISpot using assay-specific cut-off values. A minimum observation period of 9 weeks is required for patients that do not complete the entire vaccination schedule. In these patients tolerance is defined as significant decline of cellular immune response in week 9 compared to the immune response in week 1.;Timepoint(s) of evaluation of this end point: at every visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Immune response against FSP peptides. A positive immune response is defined as positive DTH response against at least one of the peptides or a humoral (ELISA for the detection of FSP-specific IgG/IgM/IgA) and/or CD8 and/or CD4 cellular (IFN gamma ELISpot for the detection of FSP-specific T cells) immune response exceeding the assay specific cut-off values for a positive response against at least one of the three peptides. • Tumor response as assessed by CT or MRI scans according to RECIST (applies for stage IV patients only) ;Timepoint(s) of evaluation of this end point: Immune response: humoral immune response at weeks 1, 3, 9, 11, 17, 19, 25 cellular immune response and DTH: weeks 1, 9, 17, 25. tumor response: every 8 weeks | — |
Countries
Germany
Contacts
Public ContactInstitut für Klin.-Onkol. Forschung
Krankenhaus Nordwest
Outcome results
None listed