NL-OMON37167
Recruiting
Not Applicable
Adoptive T cell therapy plus vaccination in metastatic melanoma patients - ACT in melanoma.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>\= 18 years.
- •2\. Histologically proven melanoma.
- •3\. Melanoma must be at one of the following AJCC 2009 stages:
- •\-Irresectable (or residual) regional metastatic melanoma, i.e. in terms of AJCC 2009 classification irresectable stage III melanoma, or
- •\-Stage IV melanoma, i.e. distant metastatic disease (any T, any N, M1a, M1b or M1c), and normal LDH.
- •4\. Patients with brain metastases have to be neurologically stable for at least 2 months and should not use dexamethasone.
- •5\. Presence of measurable progressive disease according to RECIST version 1\.1\.
- •6\. Expected survival of at least 3 months.
- •7\. WHO performance status \<\=1\.
- •8\. Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified :
Exclusion Criteria
- •Patients will be excluded from the study for any of the following reasons:;1\. Patients with brain metastases who are neurologically unstable and/or on use of dexamethasone.
- •2\. Clinically significant heart disease (NYHA Class III or IV).
- •3\. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
- •4\. Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
- •5\. Other malignancy within 2 years prior to entry into the study, except for treated non\-melanoma skin cancer and in situ cervical carcinoma.
- •6\. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •7\. Lack of availability for follow\-up assessments.
- •8\. Pregnancy or breastfeeding.
Outcomes
Primary Outcomes
Not specified
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