Etude : COLIBRI /



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
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : COLIBRI

Situation thérapeutique : Néoadjuvant / Adjuvant / Métastatique ou localement avancé

Traitement : Immunothérapie

Cadre réglementaire : RIPH2

Dernière MÀJ : 05/08/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude pilote multicentrique évaluant l’impact immunitaire et la sécurité de la combinaison nivolumab et ipilimumab avant le traitement initial par radio-chimiothérapie dans le cancer du col de l’utérus

Spécialité : Seins, organes génitaux de la femme
Localisation : C53 - Tumeur maligne du col de l'utérus
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is a multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy

Phase : NA

Stade : Localisé à Métastatique

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 : - Histologically confirmed diagnosis of cervical squamous cell carcinoma stage IB3 to IVa, (FIGO 2018)
- Patients requiring RT-CT therapy as standard of care
- Age ≥18
- Patient accepting to undergo a new cervix biopsy
- Adequate marrow function:
-> White blood cell (WBC) >2000/mm3 (stable off any growth factor within 4 weeks of first study drug administration)
-> Neutrophils >1500/ mm3 (stable off any growth factor within 4 weeks of first study drug administration)
-> Platelets > 100× 103/mm3 (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
-> Hemoglobin > 8 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
- Adequate other organ functions:
-> ALT and AST < 3× institutional ULN
-> Total bilirubin < 1.5× institutional ULN (except subjects with Gilbert's Syndrome who must have normal direct bilirubin)
-> Normal thyroid function, subclinical hypothyroidism (thyroid-stimulating hormone [TSH] < 10 mIU/mL) or have controlled hypothyroidism on appropriate thyroid supplementation
-> Serum creatinine < 2× ULN or creatinine clearance (CrCl) > 40 mL/min (measured using the Cockcroft-Gault formula below):
Female CrCl = (140 - age in years) × weight in kg × 0.85 72 × serum creatinine in mg/dL Etude COLIBRI_Version n°1.1 du 15/11/2019 vii
- General Health as evidenced by PS ≤2
- Covered by a medical insurance
- Signed and dated informed consent form prior to any study-specific procedure.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Women of childbearing potential must have a negative serum or urine pregnancy test For females of reproductive potential: use of highly effective contraception and for at least 5 months after administration of the last dose of nivolumab. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmeno-pausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus).
- All subjects must consent to allow the acquisition of blood samples, FFPE tumor tissue, either a block or 15 to 20 unstained slides, and fresh tumor for performance of correlative studies.

Critères de non-inclusion : - Pregnant or breastfeeding women.
- Patient concurrently using other approved or investigational antineoplastic agents.
- Patient candidate for neo adjuvant CT before RT-CT
- Any contraindication to nivolumab or ipilimumab treatments as per Nivolumab and Ipilimumab SPC
- Prior therapy with an immune checkpoint inhibitor
- Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years.
- Immune-deficient status (patients with HIV, immunosuppressive treatment, haematological malignancies, and previous organ transplantation)
- History of any chronic hepatitis as evidenced by:
-> Positive test for hepatitis B surface antigen
-> Positive test for qualitative hepatitis C viral load (by polymerase chain reaction [PCR]) Etude COLIBRI_Version n°1.1 du 15/11/2019 viii Note: Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible. History of resolved hepatitis A virus infection is not an exclusion criterion
- Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
-> Myocardial infarction or stroke/transient ischemic attack within the past 6 months
-> Uncontrolled angina within the past 3 months
-> History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, or myocarditis)
-> Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
-> QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation > 480 msec
-> Cardiovascular disease-related requirement for daily supplemental oxygen therapy
- Subjects with known or suspected CNS metastases, untreated CNS metastases, are excluded.
Note: However, subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms.
• Patients requiring concomitant treatment with therapeutic doses of anticoagulants will not be eligible for this clinical trial.
Note: Patients treated with low dose of anticoagulants for thrombo-embolic events prophylaxis are allowed.
• Any major surgery within 4 weeks of study drug administration. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study drug.
Note: Pelvic and aortic dissection is not considered as traumatic surgery, and therefore can be performed if clinically indicated.
- Subjects with active, known or suspected autoimmune disease. Note: Subjects with skin disorders (such as vitiligo, psoriasis or alopecia), type I diabetes mellitus, hypothyroidism only requiring hormone, replacement or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
Note: Inhaled or topical steroids, and adrenal replacement doses are permitted in the absence of active autoimmune disease.)
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04256213
Promoteur :
ARCAGY-GINECO
Type de sponsor : Institutionnel
75004 PARIS 04

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Florence JOLY

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Statut de l'essai : CLOS

MAJ : 05/08/2021