Actively Recruiting
Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Led by Hospital Israelita Albert Einstein · Updated on 2024-01-05
112
Participants Needed
14
Research Sites
291 weeks
Total Duration
On this page
Sponsors
H
Hospital Israelita Albert Einstein
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants older than 18 years
- Diagnosis of cervical adenocarcinoma or squamous carcinoma at 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 one lesion qualifying as a RECIST 1.1 target lesion at baseline that has not been previously irradiated
You will not qualify if you...
- Diagnosis of small cell (neuroendocrine) histology cervical cancer
- Intention to undergo fertility-sparing treatment
- Previous hysterectomy
- Evidence of metastatic disease including lymph nodes ≥15 mm above the L1 vertebral body or outside the planned radiation field
- History of allogeneic organ transplantation
- Active or prior autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness
- History of another primary malignancy or active primary immunodeficiency
- Active infection
- Laboratory abnormalities: WBC count < 2000/μL; neutrophils < 1500/μL; platelets < 100,000/μL; hemoglobin < 9.0 g/dL; serum creatinine > 1.5 x ULN unless creatinine clearance ≥ 40 mL/min; AST/ALT > 3.0 x ULN; total bilirubin > 1.5 x ULN (except Gilbert Syndrome with bilirubin < 3.0 x ULN)
- Positive test for hepatitis B or C virus indicating presence of infection
- Use of systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressive drugs within 14 days before treatment
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
CRIO -Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil, 60335-480
Actively Recruiting
2
Clinica AMO
Salvador, Estado de Bahia, Brazil, 41810-011
Actively Recruiting
3
Hospital das Clinicas da UFMG
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Not Yet Recruiting
4
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil, 81520-060
Not Yet Recruiting
5
Multi Oncoclinicas Recife
Recife, Pernambuco, Brazil, 50070-460
Actively Recruiting
6
Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil, 90610-001
Not Yet Recruiting
7
Universidade Federal de Roraima
Boa Vista, Roraima, Brazil, 69310-000
Actively Recruiting
8
CEPON - Florianópolis
Florianópolis, Santa Catarina, Brazil, 88034-000
Not Yet Recruiting
9
Hospital de Amor
Barretos, São Paulo, Brazil, 14784-400
Not Yet Recruiting
10
Hospital De Base de São José do Rio Preto - CIP São José
São José do Rio Preto, São Paulo, Brazil, 15090-000
Not Yet Recruiting
11
INCA - Instituto Nacional do Cancer
Rio de Janeiro, Brazil, 20230-130
Not Yet Recruiting
12
AC Camargo Cancer Center
São Paulo, Brazil, 01509-001
Not Yet Recruiting
13
Hospital Municipal Vila Santa Catarina
São Paulo, Brazil, 04378-500
Actively Recruiting
14
Hospital Israelita Albert Einstein
São Paulo, Brazil, 05652-900
Actively Recruiting
Research Team
D
Diogo Bugano, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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