Status and phase
Conditions
Treatments
About
This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. :
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Contra-indication to Nivolumab and /or Vinblastin
Subjects with active interstitial pneumonitis
Subjects with active infectious disease
Subjects with active, known or suspected autoimmune disease. Are permitted to enroll: subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Any serious active disease, severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment (according to the investigator's decision)
Any of the following abnormal laboratory values (unless due to underlying HL) :
Any history of cancer evolution requiring therapy during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if :
Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
Adult person under legal protection
Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
Subjects with know Human Immunodeficiency Virus (HIV) positivity
Subjects with known active hepatitis B (HB) infection (positive Ag HB s or positive DNA polymerase chain reaction (PCR) or positive antibody anti-HB c with lack of antibody against HBs) or active hepatitis C infection (patients with positive HCV serology are eligible only if PCR is negative for known hepatitis C virus (HCV RNA)
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease.
Primary purpose
Allocation
Interventional model
Masking
64 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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