Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Last updated: January 3, 2024
Sponsor: Hospital Israelita Albert Einstein
Overall Status: Active - Recruiting

Phase

2

Condition

Uterine Disorders

Cervical Cancer

Treatment

Ipilimumab 200 MG in 40 ML Injection

Nivolumab 40 mg in 4 ml Injection

Chemoradiation

Clinical Study ID

NCT05492123
BRAVA- Cervical - SGPP 5031-21
  • Ages 18-95
  • Female

Study Summary

A total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. The primary outcome will be 3-year disease-free survival.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female participants older than 18 years
  • Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO StageIB2-IB3 node positive or Stage IIB-IVA
  • No prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervicalcancer
  • WHO/ECOG performance status of 0-1
  • At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TargetLesion at baseline.

Exclusion

Exclusion Criteria:

  • Diagnosis of small cell (neuroendocrine) histology cervical cancer
  • Intent to administer a fertility-sparing treatment regimen
  • Undergone a previous hysterectomy
  • Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (shortaxis) above the L1 cephalad body or outside the planned radiation field.
  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness
  • History of another primary malignancy and active primary immunodeficiency
  • Patients with active infection Laboratory values that fall into:
  1. WBC count (WBC) < 2000/μL ;
  2. Neutrophil count < 1500/μL;
  3. Platelet count < 100 x 103/μL;
  4. Hemoglobin level < 9.0 g/dL;
  5. Serum creatinine > 1.5 x upper limit of normal (ULN) unless creatinine clearance is ≥ 40 mL/min (measured or calculated using the Cockcroft-Gault formula);
  6. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): > 3.0 x ULN;
  7. Total bilirubin > 1.5 x ULN (except participants with Gilbert Syndrome who must have atotal bilirubin level of < 3.0 x ULN);
  8. Any positive test result for hepatitis B virus or hepatitis C virus that indicates thepresence of the virus, for example, positive Hepatitis B surface antigen (HBsAg,Australia antigen) or Hepatitis C antibodies (anti- HCV) positive (unless the HCV-RNAis negative).
  • Participants with a condition requiring systemic treatment or withcorticosteroids (>10 mg daily of a prednisone equivalent) or otherimmunosuppressive drugs within 14 days of initiating study treatment.
  • Pregnant or breastfeeding woman

Study Design

Total Participants: 112
Treatment Group(s): 3
Primary Treatment: Ipilimumab 200 MG in 40 ML Injection
Phase: 2
Study Start date:
August 30, 2022
Estimated Completion Date:
March 31, 2028

Study Description

Patients with adenocarcinoma or squamous cell carcinoma of the cervix, FIGO Stage IB2-IB3 node positive or Stage IIB-IVA will be randomized to conventional cisplatin-based chemo-radiation or to 4 cycles of induction immunotherapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks, followed by cisplatin chemo-radiation with concurrent nivolumab 240mg every 2 weeks. Primary outcome will be 3-year progression-free survival.

Connect with a study center

  • Clinica AMO

    Salvador, Bahia 41810-011
    Brazil

    Active - Recruiting

  • CRIO -Centro Regional Integrado de Oncologia

    Fortaleza, Ceará 60335-480
    Brazil

    Active - Recruiting

  • Hospital das Clinicas da UFMG

    Belo Horizonte, Minas Gerais 30130-100
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner

    Curitiba, Paraná 81520-060
    Brazil

    Site Not Available

  • Multi Oncoclinicas Recife

    Recife, Pernambuco 50070-460
    Brazil

    Active - Recruiting

  • Hospital São Lucas - PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-001
    Brazil

    Site Not Available

  • Universidade Federal de Roraima

    Boa Vista, Roraima 69310-000
    Brazil

    Active - Recruiting

  • CEPON - Florianópolis

    Florianópolis, Santa Catarina 88034-000
    Brazil

    Site Not Available

  • Hospital de Amor

    Barretos, São Paulo 14784-400
    Brazil

    Site Not Available

  • Hospital De Base de São José do Rio Preto - CIP São José

    São José Do Rio Preto, São Paulo 15090-000
    Brazil

    Site Not Available

  • INCA - Instituto Nacional do Cancer

    Rio De Janeiro, 20230-130
    Brazil

    Site Not Available

  • AC Camargo Cancer Center

    São Paulo, 01509-001
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900
    Brazil

    Active - Recruiting

  • Hospital Municipal Vila Santa Catarina

    São Paulo, 04378-500
    Brazil

    Active - Recruiting

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