A phase I/II study with adoptive TIL-therapy in combination with anti-PD1 (Nivolumab) in patients with metastatic skin melanoma

Phase 1

• Conditions: Metastatic melanoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004426-41-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-29
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age = 18 years.
2.Histologically or cytologically proven metastatic skin melanoma.
3.Melanoma must be at one of the following AJCC 2009 stages:
-Unresectable (or residual) regional metastatic melanoma, i.e. in terms of AJCC 2009 classification unresectable 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 :
Lab ParameterRange
Hemoglobin= 6,0 mmol/l
Granulocytes= 1,500/µl
Lymphocytes= 700/µl
Platelets= 100,000/µl
Creatinine clearance= 60 min/ml
Serum bilirubin= 40 mol/l
ASAT and ALAT= 5 x the normal upper limit
LDH= 2 x the normal upper limit
9.Viral tests:
-Negative for HIV type 1/2, HTLV and TPHA
-No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum
-No antibodies against HCV (hepatitis C virus) in the serum
10.Able and willing to give valid written informed consent.
11.Prior treatment is allowed, including anti-PD1 treatment, but systemic therapy must have been discontinued for at least four weeks before study entry. Radiotherapy and targeted therapy should be discontinued for at least two weeks before study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified