COL Immunotherapy Before Radiochimio + Ipilimumab

NCT04256213 | Completed DMC

• 2 other identifiers: GINECO-CE108b2019-002271-34
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Cervix Cancer

Keywords

Cervix cancer; Immune combination

Outcome Measures

Primary Outcomes (1)

• CD8+/FOXP3+ relative change of lymphocytes from pre to post treatment biopsies

  Baseline, before RT-CT

Secondary Outcomes (4)

• Adverse events

  Up to 100-days after end of treatment or until initiation of alternative cancer therapy

• Objective Response Rate

  1week before RT-CT, 4 weeks after RT-CT

• Progression Free Survival

  1 year

• Overall Survival

  3 years

Study Arms (1)

Nivolumab + Ipilimumab

EXPERIMENTAL

Drug: Nivolumab and Ipilimumab

Interventions

Nivolumab and Ipilimumab DRUG

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)

Nivolumab + Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or the MDRD formula for patients older than 65 years-old
• General Health as evidenced by PS ≤2

You may not qualify if:

• 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 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 \[PCR\])
• 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)

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead
• Bristol-Myers Squibb: collaborator

Study Sites (8)

Centre François Baclesse

Caen, 14000, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Groupe Hospitalier Diaconesses - Croix Saint-Simon

Paris, 75020, France

Location

Institut Curie

Paris, 75278, France

Location

Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, CARIO-HPCA

Plérin, 22190, France

Location

Institut Jean Godinot

Reims, 51726, France

Location

Institut Claudius Regaud IUCT-O

Toulouse, 31059, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Isabelle RAY-COQUARD, MD, PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: July 2, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 4, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

FR (8)