Combined Therapy of Nivolumab and Adoptive T Cell Therapy in Metastatic Melanoma Patients (Nivo-TIL)

STATUS

Recruiting
End date

Jan 11, 2024
participants needed

11
sponsor

Nantes University Hospital

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Updated on 11 May 2022

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metastatic melanoma

cancer

immunosuppressant

prednisone

interleukin-2

gilbert's syndrome

BRAF

metastasis

neutrophil count

tumor cells

brain metastases

mitomycin

nivolumab

aldesleukin

braf inhibitor

vitiligo

immunomodulators

braf v600 mutation

immunologic adjuvant

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
Treatment	TIL + IL-2 + Nivolumab
Clinical Study Identifier	NCT03374839
Sponsor	Nantes University Hospital
Last Modified on	11 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	over 18 years old 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
	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/μl; Leukocytes ≥ 4000/μl
	Lymphocytes ≥ 700/μl; Blood platelet ≥ 100.000/μl; 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) ≤ 1.5 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
	Non inclusion Criteria
	during the clinical trial and for a period of 7 months after the last dose of
	Brain or bone metastases
	Nivolumab
	Ocular melanoma
	Women who are not of childbearing potential (ie, who are postmenopausal or surgically
	sterile) as well as azoospermic men do not require contraception
	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
	Chemotherapy or radiotherapy within 4 weeks before baseline (6 weeks for nitroso-ureas
	and mitomycin C)
	History of allergies and Adverse Drug Reaction
	Hypersensitivity to human albumin, TIL excipient
	Hypersensitivity to Nivolumab or related excipients
	History or current manifestations of severe progressive heart disease (congestive
	History of severe hypersensitivity reaction to any monoclonal antibody
	heart failure, coronary artery disease, uncontrolled arterial hypertension, serious
	Hypersensitivity to aldesleukin or to one of Proleukin excipients
	rhythm disorders or ECG signs of previous myocardial infarction)
	Patients should be excluded if they have had prior treatment with an anti-PD-1
	History of uveitis or melanoma-associated retinopathy
	anti-PD-L1, anti-PD-L2, anti-CTLA4 antibody, or any other antibody or drug
	specifically targeting T-cell costimulation or immune checkpoint pathways except in
	Unchecked thyroid dysfunction
	the context of adjuvant or neoadjuvant
	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 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
	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

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Study Definition

Wikipedia

Combined Therapy of Nivolumab and Adoptive T Cell Therapy in Metastatic Melanoma Patients (Nivo-TIL)