Etude : CheckMate 76K / CA209-76K /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CheckMate 76K / CA209-76K

Nom :

Traitement : Adjuvant

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 05/02/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma

Spécialité : Peau
Localisation : C43 - Mélanome malin de la peau
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Study arms:
- Experimental: Nivolumab (specified dose on specified days)
- Placebo Comparator: 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

1
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
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04099251
Promoteur :
BRISTOL MYERS SQUIBB
Type de sponsor : Industriel
BRISTOL MYERS SQUIBB - BRISTOL MYERS SQUIBB
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Laurent MORTIER

TEC / ARC / IDE :
Benoît MINART
benoit.minart@
chru-lille.fr
03 20 44 64 15

Statut de l'essai : OUVERT

MAJ : 21/01/2020