Trial Title:
Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
NCT ID:
NCT05492123
Condition:
Uterine Cervical Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
Nivolumab
Ipilimumab
Conditions: Keywords:
Uterine Cervical Neoplasms
Nivolumab
Ipilimumab
Chemoradiation
Anti-PD1
Anti-PDL1
Anti-CTLA4
Immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective randomized trial, stratified by center, disease stage and type of radiation
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nivolumab 40 mg in 4 ml Injection
Description:
Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks
with concurrent radiation
Arm group label:
Immunotherapy
Other name:
Opdivo
Intervention type:
Drug
Intervention name:
Ipilimumab 200 MG in 40 ML Injection
Description:
Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation
Arm group label:
Immunotherapy
Other name:
Yervoy
Intervention type:
Radiation
Intervention name:
Chemoradiation
Description:
Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent
weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w
Arm group label:
Immunotherapy
Arm group label:
Standard Chemoradiation
Other name:
Cisplatin-based chemoradiation
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female participants older than 18 years
- Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage
IB2-IB3 node positive or Stage IIB-IVA
- No prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervical
cancer
- WHO/ECOG performance status of 0-1
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target
Lesion at baseline.
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 (short
axis) 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
a total bilirubin level of < 3.0 x ULN);
8. Any positive test result for hepatitis B virus or hepatitis C virus that indicates
the presence of the virus, for example, positive Hepatitis B surface antigen (HBsAg,
Australia antigen) or Hepatitis C antibodies (anti- HCV) positive (unless the
HCV-RNA is negative).
- Participants with a condition requiring systemic treatment or with
corticosteroids (>10 mg daily of a prednisone equivalent) or other
immunosuppressive drugs within 14 days of initiating study treatment.
- Pregnant or breastfeeding woman
Gender:
Female
Minimum age:
18 Years
Maximum age:
95 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinica AMO
Address:
City:
Salvador
Zip:
41810-011
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Aknar Calabrich
Phone:
+55(71)3021-8735
Email:
aknar@clinicaamo.com.br
Investigator:
Last name:
Aknar Calabrich
Email:
Principal Investigator
Facility:
Name:
CRIO -Centro Regional Integrado de Oncologia
Address:
City:
Fortaleza
Zip:
60335-480
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Eduardo Cronemberger
Phone:
+55(85)3286-5934
Email:
cronmeberger.eduardo@gmail.com
Investigator:
Last name:
Eduardo Cronemberger, MD
Email:
Principal Investigator
Facility:
Name:
Hospital das Clinicas da UFMG
Address:
City:
Belo Horizonte
Zip:
30130-100
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Angélica Nogueira
Phone:
+55(31)3307-9255
Email:
angélica.onco@uol.com.br
Investigator:
Last name:
Angélica Nogueira, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Erasto Gaertner
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Reitan Ribeiro
Phone:
+55(41)3361-5195
Email:
reitanribeiro@hotmail.com
Investigator:
Last name:
Reitan Ribeiro, MD
Email:
Principal Investigator
Facility:
Name:
Multi Oncoclinicas Recife
Address:
City:
Recife
Zip:
50070-460
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Carla Rameri
Phone:
+55(81)2122-4792
Email:
carla.rameri.de.azevedo@gmail.com
Investigator:
Last name:
Carla Rameri, MD
Email:
Principal Investigator
Facility:
Name:
Hospital São Lucas - PUCRS
Address:
City:
Porto Alegre
Zip:
90610-001
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Fernanda Damian
Phone:
+55(51)3320-3039
Email:
fernandadamian@yahoo.com.br
Investigator:
Last name:
Fernanda Damian
Email:
Principal Investigator
Facility:
Name:
Universidade Federal de Roraima
Address:
City:
Boa Vista
Zip:
69310-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Allex Jardim
Phone:
+55(95)3224-4712
Email:
allex.j.fonseca@gmail.com
Investigator:
Last name:
Allex Jardim, MD, PhD
Email:
Principal Investigator
Facility:
Name:
CEPON - Florianópolis
Address:
City:
Florianópolis
Zip:
88034-000
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Anne Schmitz
Phone:
+55(48)3331-1553
Email:
anneschmitz@uol.com.br
Investigator:
Last name:
Anne Schmitz, MD
Email:
Principal Investigator
Facility:
Name:
Hospital de Amor
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Maria Fernanda Biazzotto
Phone:
+55(17)3321-6638
Email:
nandabiazotto@hotmail.com
Investigator:
Last name:
Maria Fernanca Biazzotto, MD
Email:
Principal Investigator
Facility:
Name:
Hospital De Base de São José do Rio Preto - CIP São José
Address:
City:
São José Do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
João Daniel
Phone:
+55(17)3201-5054
Email:
joaodcguedes@gmail.com
Investigator:
Last name:
João Daniel, MD
Email:
Principal Investigator
Facility:
Name:
INCA - Instituto Nacional do Cancer
Address:
City:
Rio De Janeiro
Zip:
20230-130
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Adriana Melo
Phone:
+55(21)3207-2985
Email:
andreia.melo@inca.gov.br
Investigator:
Last name:
Andreia Melo, MD
Email:
Principal Investigator
Facility:
Name:
AC Camargo Cancer Center
Address:
City:
São Paulo
Zip:
01509-001
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Natasha Carvalho
Phone:
+55(11)2189-5021
Email:
natasha.pandolfi@accamargo.org.br
Investigator:
Last name:
Natasha Carvalho, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Municipal Vila Santa Catarina
Address:
City:
São Paulo
Zip:
04378-500
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Ana Lucia Neves
Phone:
2151-1223
Phone ext:
0
Email:
ana.neves@einstein.br
Investigator:
Last name:
Henrique A Helber, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Israelita Albert Einstein
Address:
City:
São Paulo
Zip:
05652-900
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Fernando Maluf
Contact backup:
Last name:
Diogo Bugano
Email:
diogo.gomes@einstein.br
Investigator:
Last name:
Fernando Maluf
Email:
Principal Investigator
Start date:
August 30, 2022
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Hospital Israelita Albert Einstein
Agency class:
Other
Collaborator:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
Brava
Agency class:
Industry
Source:
Hospital Israelita Albert Einstein
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05492123
