CompletedPhase 1

TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma

France33 participantsStarted 2017-10-16

Plain-language summary

This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in patients with advanced melanoma.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 2009), including mucosal melanoma, without evidence of active intra-cranial disease.
✓. Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
✓. Measurable disease per RECIST 1.1
✓. Age ≥18 years and ≤70 years at the time of study entry.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
✓. Life expectancy of at least 3 months.
✓. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures and to comply with the study protocol.
✓. Screening laboratory values must meet the following criteria and should be obtained prior to commencement of treatment:

Exclusion criteria

✕. Patient pregnant, or breast-feeding.
✕. Uveal melanoma.
✕. Active and/or symptomatic intra cranial metastasis (including melanomatous meningitis). Patients with intra cranial metastasis may be eligible if all known lesions have been treated with stereotactic radiotherapy or surgery or both AND there has been no magnetic resonance imaging (MRI) evidence of disease progression in the CNS for ≥ 4 weeks after treatment and within 28 days prior the first dose of study drug administration.
✕. Previous treatment with B-RAF or MEK inhibitors within 12 weeks prior start of treatment.
✕. Hypersensitivity to the drugs of the study.
✕. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of 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.
✕. Clinically significant cardiac dysfunction including congenital, familial, and genetic cardiac disorders, current instable angina, current symptomatic congestive heart failure of NYHA class 2 and higher, current uncontrolled hypertension ≥ grade 3; Left Ventricular Ejection Fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower.
✕. Patient with active malignancy other than melanoma or a history of previous within the past 3 years; except for patients with resected Basal cell carcinoma or resected Spindle cell carcinoma, resected carcinoma in situ of the cervix and resected carcinoma in situ of the breast.

What they're measuring

Dose Limiting Toxicities (DLT) incidence, in part 1 of the study.

Timeframe: 12 weeks per patient (part 1)

Trial details

NCT IDNCT03293784

SponsorInstitut Claudius Regaud

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-06

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