Etude : CheckMate 76K / CA209-76K /

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : CheckMate 76K / CA209-76K

Situation thérapeutique : Adjuvant

Traitement : Immunothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 13/12/2021
CIM10 - Localisation(s)
Informations principales
Titre : Étude d’efficacité du nivolumab par rapport au Placebo dans la prévention du mélanome récurrent après résection complète d’un mélanome de stade IIB/C - CA209-76K

Spécialité : Peau
Localisation : C43 - Mélanome malin de la peau
Informations complémentaires
Schéma : L’objectif de cette étude est de déterminer l’efficacité de l’IMMUNOTHÉRAPIE adjuvante par nivolumab par rapport au Placebo chez des participants adultes et pédiatriques après résection complète d’un mélanome de stade IIB/C sans signe de maladie (NED), à haut risque de récidive.

Groupes de l'étude:
- Experimental: Nivolumab (specified dose on specified days)
- Contrôle par Placebo : Placebo (placebo equivalent specified dose on specified days)

Main objective of the trial:
To compare the efficacy, as measured by recurrence free survival (RFS), provided by nivolumab monotherapy versus placebo in participants with completely resected stage IIB/C melanoma with no evidence of disease

Secondary objectives of the trial
- To compare the overall survival (OS) provided by nivolumab monotherapy versus placebo in participants with completely resected stage IIB/C melanoma with no evidence of disease, who are at high risk for recurrence.
- To assess safety and toxicity of nivolumab monotherapy in participants with completely resected stage IIB/C melanoma with no evidence of disease.
- To evaluate distant metastases-free survival (DMFS)
- To evaluate investigator-assessed outcomes on nextline therapies.

Phase : III

Stade : Localisé

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 1) Participants must have been diagnosed with stage IIB/C cutaneous melanoma (AJCC Cancer Staging, 8th edition) and have histologically confirmed melanoma that is completely surgically resected with documented negative margins (per local standard) for disease on resected specimens. All melanomas, except ocular and mucosal melanoma, regardless of primary site of disease will be allowed.
2) Complete resection must be performed within 12 weeks prior to randomization.
Participants must have had a negative sentinel lymph node biopsy. Patients in whom a sentinel lymph node biopsy procedure could not be done or a sentinel lymph node was not detected are not eligible.
3) Participants must have disease-free status documented by a complete physical examination (within 14 days) and imaging studies within 4 weeks (28 days) prior to randomization.
Imaging studies must include CT scans of the chest/abdomen/pelvis or CT scan of the chest and MRI scans of the abdomen and pelvis, and all known sites of resected disease (lymph nodes ≥ 15 mm in short axis). Participants with signs and symptoms consistent with brain metastases should have imaging studies done to rule out the presence of brain metastases.
4) Has not been previously treated for melanoma beyond complete surgical resection of the melanoma lesion.
5) Has recovered adequately from toxicity and/or complications from surgery prior to study start.
6) ECOG performance status of 0 or 1 at the time of enrollment
7) Tumor tissue (minimum of 15 unstained slides or 1 FFPE block) from the resected site of disease must be provided to the central lab prior to randomization

Critères de non-inclusion : 1) History of ocular and mucosal melanoma.
2) Participants with active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
3) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
4) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
5) Women who are pregnant or breastfeeding
6) Participants with serious or uncontrolled medical disorder
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Laurent MORTIER

03 20 44 64 15

Statut de l'essai : CLOS

MAJ : 22/09/2021