A MULTICENTER, SEEKING SIGNAL, RANDOMISED, OPEN-LABEL PHASE II OF RELATLIMAB AND NIVOLUMAB VS NIVOLUMAB ALONE IN LOCALLY ADVANCED CERVICAL CANCERS

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Multicenter, open-label, randomized, seeking signal (non-comparative), Phase II aiming to assess the clinical activity of the combination relatlimab + nivolumab in locally advanced cervical cancer eligible to standard CCRT

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Female patients aged ≥18 years at time of inform consent signature.

• Patients must have histologically confirmed diagnosis of cervical squamous or adenosquamous carcinoma stage IIB to IVA according to FIGO 2018 (Appendix 1) and no evidence of metastatic disease (M0). Note: Nodal staging may be either surgical or by imaging (MRI/PET-CT) with pathological lymph node size defined by a short-axis diameter of ≥10mm (axial plane) or FDG uptake greater than that of the surrounding tissue and corresponding to the LN structure on CT when CT was performed for PETCT analysis.

• Patients must be naïve from prior anti-cancer treatment (all type) and eligible to standard CCRT as per standard practice and investigator' judgement.

• Known HPV status as per local assessment.

• Patient accepting to undergo a new cervix biopsy and with at least one lesion with a diameter ≥10 mm, visible by medical imaging and accessible to percutaneous sampling (needle biopsies 16 gauge or larger) that permit core needle biopsy (ideally 4 cores) without unacceptable risk of a major procedural complication.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix 2).

• Adequate organ and marrow function with following lab values within 7 days before C1D1:

‣ Absolute neutrophil count (ANC) ≥1500/μL

⁃ White blood cell (WBC) \>3000/μL

⁃ Platelets ≥100 000/μL

⁃ Hemoglobin (Hb) ≥9 g/dL

⁃ Total bilirubin ≤1.5× upper limit of normal (ULN) unless due to Gilbert's syndrome

⁃ ASAT /ALAT ≤3 ULN

⁃ Creatinine ≤1.5 within normal limit, or

⁃ Creatinine clearance ≥ 40 mL/min according to CKD-EPI formula (Appendix 3)

⁃ Troponin T or I \< 2 x ULN

• Adequate cardiovascular function documented by:

‣ QTc interval \<450 msec.

⁃ Left ventricular Ejection fraction \> 50% based on screening echocardiogram (ECHO) or multigated acquisition scan (MUGA).

⁃ Controlled blood pressure (BP, \<150/90mmHg), with or without current antihypertensive treatment.

⁃ No congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes).

⁃ No stroke (including transient ischemic attack \[TIA\]), myocardial infarction, or other clinically significant ischemic event within 12 months before first dose.

⁃ No prior history of myocarditis.

• Women of childbearing potential

‣ must have a negative serum pregnancy test within 7 days prior C1D1 and use adequate contraceptive methods (for example, intrauterine device \[IUD\], birth control pills unless clinically contraindicated, or barrier device - see Appendix 4) beginning 2 weeks before the first dose of study drugs and for up to 6 months after the final dose of study drugs (i.e., 30 days \[duration of ovulatory cycle\] plus the time required for relatlimab and nivolumab to undergo approximately five halflives).

⁃ A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal 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).

• Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry.

• Covered by a medical insurance.

Locations
Other Locations
France
ICO Paul Papin
RECRUITING
Angers
Sainte-Catherine Institut du Cancer Avignon-Provence
RECRUITING
Avignon
CHRU Besançon - Hôpital Jean Minjoz
RECRUITING
Besançon
Institut Bergonié
RECRUITING
Bordeaux
CHU de BREST - Hôpital Cavale Blanche
RECRUITING
Brest
Centre François Baclesse
RECRUITING
Caen
Centre Jean Perrin
NOT_YET_RECRUITING
Clermont-ferrand
Centre Hospitalier Intercommunal de Créteil
RECRUITING
Créteil
CHU de Dijon
RECRUITING
Dijon
Soumya.Anane@chicreteil.fr
RECRUITING
Dijon
Centre Oscar Lambret
NOT_YET_RECRUITING
Lille
CHRU Lille - Hôpital Jeanne de Flandre
NOT_YET_RECRUITING
Lille
CHU de Limoges - Hôpital Dupuytren
RECRUITING
Limoges
Centre Léon Bérard
RECRUITING
Lyon
Institut Paoli Calmettes
RECRUITING
Marseille
ICM Val d'Aurelle
WITHDRAWN
Montpellier
Centre Antoine Lacassagne
RECRUITING
Nice
Groupe Hospitalier Diaconesses - Croix Saint-Simon
RECRUITING
Paris
Institut Curie
RECRUITING
Paris
Centre Hospitalier Lyon Sud
NOT_YET_RECRUITING
Pierre-bénite
Centre CARIO - HPCA
RECRUITING
Plérin
CHU de Poitiers - Hôpital de la Milétrie
NOT_YET_RECRUITING
Poitiers
Centre Eugène Marquis
RECRUITING
Rennes
CHU Saint-Etienne - Pôle de Cancérologie
RECRUITING
Saint-etienne
ICO - Centre René Gauducheau
RECRUITING
Saint-herblain
ICANS - Institut de cancérologie Strasbourg Europe
RECRUITING
Strasbourg
Oncopole Claudius Regaud
NOT_YET_RECRUITING
Toulouse
CHRU de Tours - Hôpital Bretonneau - Centre Henry Kaplan
WITHDRAWN
Tours
Recherche Oncologique Clinique 37 (ROC 37)
RECRUITING
Tours
ICL - Centre Alexis Vautrin
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Latifa BOUDALI
lboudali@arcagy.org
+33184852042
Backup
Pr Isabelle RAY-COQUARD, Investigator coordinator
isabelle.ray-coquard@lyon.unicancer.fr
Time Frame
Start Date: 2024-12-11
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 77
Treatments
Experimental: Arm A: Nivolumab and relatlimab
Other: Arm B: Nivolumab only
Related Therapeutic Areas
Sponsors
Leads: ARCAGY/ GINECO GROUP

This content was sourced from clinicaltrials.gov