Combined Therapy of Nivolumab and Adoptive T Cell Therapy in Metastatic Melanoma Patients

  • STATUS
    Recruiting
  • End date
    Mar 12, 2023
  • participants needed
    11
  • sponsor
    Nantes University Hospital
Updated on 23 January 2021
metastatic melanoma
cancer
immunosuppressant
prednisone
interleukin-2
gilbert's syndrome
BRAF
metastasis
neutrophil count
tumor cells
brain metastases
mitomycin
nivolumab
aldesleukin
braf inhibitor
vitiligo
braf v600 mutation
ocular melanoma

Summary

To improve the efficacy of immunotherapy for cancer, recent studies focused on specific targets to redirect the immune network toward eradicating a variety of tumors and ameliorating the self-destructive process.

A clinically relevant immune escape mechanism in melanoma is the activation of the Programmed cell Death-1 (PD-1) receptor on infiltrating T cells. By blocking PD-1 receptors with anti-PD-1 monoclonal antibodies (mAbs), T-cells are unaffected by the PD-L1 expressed on tumor cells and the patients T cells are free to respond to melanoma antigens and attack tumor cells. So the objective of this trial is to evaluate the safety and the efficacy of a combined therapy Nivolumab and adoptive T cell therapy in metastatic melanoma patients.

Details
Condition melanoma, Malignant Melanoma, Metastatic Melanoma, melanoma, skin cancer, skin cancer, Metastatic Melanoma, Malignant Melanoma
Treatment TIL + IL-2 + Nivolumab
Clinical Study IdentifierNCT03374839
SponsorNantes University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

to 75 years with a weight 40 kg
Patients must have signed informed consent
Patients with stage IIIb, IIIc or IV metastatic melanoma (AJCC 6th edition) with at least two lesions (lymph nodes relapse, or in transit metastasis, or unresectable cutaneous metastases, or visceral metastases except bone and brain metastases) including one easily accessible and no more than 2 lines of treatment of melanoma at the metastatic stage
Patients with a melanoma expressing a Braf V600 mutation can be included only in case of targeted biotherapy (BRAF inhibitor +/- mitogen-activated protein kinase kinase enzymes (MEK) inhibitor) failure
Measurable/assessable disease in 28 days which precede the first administration of the treatment
A negative pregnancy test for women with childbearing potential
Eastern Cooperative Oncology Group (ECOG) of 0-1, Karnofsky > 80%
Laboratory results
Haemoglobin 10 g/dl or 6,25 mmol/l; Neutrophils 1500/l; Leukocytes 4000/l
Lymphocytes 700/l; Blood platelet 100.000/l; Serum creatinine 1.5 x superior
normal value or creatinine clearance (CrCl) 40 mL/min (if using the Cockcroft-
Gault formula); Serum bilirubin 2.0 mg/dl or 34.2 mol/l; Total bilirubin 1.5 x
superior normal value (except subjects with Gilbert Syndrome, who can have
total bilirubin < 3mg/dL); Aspartate aminotransferase (AST) and Alanine
aminotransferase (ALT) 2 x superior normal value; Lactate dehydrogenase (LDH)
5 x superior normal value
Subjects affiliated to an appropriate health insurance
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception during the clinical trial. Furthermore WOCBP will be instructed to adhere to contraception for a period of 5 months after the last dose of Nivolumab
Men who are sexually active with WOCBP will be instructed to adhere to contraception during the clinical trial and for a period of 7 months after the last dose of Nivolumab
Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
Non inclusion Criteria
Brain or bone metastases
Ocular melanoma
Chemotherapy or radiotherapy within 4 weeks before baseline (6 weeks for nitroso-ureas and mitomycin C)
Contraindication for the use of vasopressor agents
For female: the patient is pregnant or breastfeeding or not using contraception
For men: the patient is sexually active with WOCBP and not using contraception
History or current manifestations of severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, serious rhythm disorders or ECG signs of previous myocardial infarction)
Patients should be excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
History of allergies and Adverse Drug Reaction
Hypersensitivity to human albumin, TIL excipient
Hypersensitivity to Nivolumab or related excipients
History of severe hypersensitivity reaction to any monoclonal antibody
Hypersensitivity to aldesleukin or to one of Proleukin excipients
History of chronic autoimmune disease (Addison's disease, multiple sclerosis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, etc) except patient with active vitiligo or a history of vitiligo
History of uveitis or melanoma-associated retinopathy
History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea
Presence of a second active cancer, with the exception of an in situ cervical cancer or a skin cancer different from the treated melanoma
Unchecked thyroid dysfunction
Any serious, acute or chronic illness id est active infection asking for antibiotics administration, coagulation's disorders, or any state asking for an unauthorized concomitant treatment described in this study
Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of nonautoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted
Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")

Exclusion Criteria

Positive viral serology for HIV (human immunodeficiency virus) 1/2, p24 Ag, HTLV1, HTLV2, B and C hepatitis or syphilis
Clear my responses

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