Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2020-07-02
2024-08-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will also assess tolerability, Objective Response Rate, clinical activity and biological (dynamic) changes of the immune micro environment
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nivolumab + Ipilimumab
Nivolumab and Ipilimumab
Nivolumab, IV D1C1 and D15C1 (before RT-CT) at 3 mg/kg Every 28 days at 480 mg during 6 months after RT-CT
Ipilimumab, 1 mg/kg, IV D1C1 (before RT-CT)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab and Ipilimumab
Nivolumab, IV D1C1 and D15C1 (before RT-CT) at 3 mg/kg Every 28 days at 480 mg during 6 months after RT-CT
Ipilimumab, 1 mg/kg, IV D1C1 (before RT-CT)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 or the MDRD formula for patients older than 65 years-old
* 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.
Exclusion Criteria
* 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 Investigator's Brochure
* 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 \[PCR\])
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.)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
ARCAGY/ GINECO GROUP
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabelle RAY-COQUARD, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre François Baclesse
Caen, , France
Centre Léon Bérard
Lyon, , France
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, , France
Institut Curie
Paris, , France
Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, CARIO-HPCA
Plérin, , France
Institut Jean Godinot
Reims, , France
Institut Claudius Regaud IUCT-O
Toulouse, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-002271-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GINECO-CE108b
Identifier Type: -
Identifier Source: org_study_id