Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
NCT ID: NCT05492123
Last Updated: 2024-01-05
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
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RECRUITING
PHASE2
112 participants
INTERVENTIONAL
2022-08-30
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Chemoradiation
Traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week or carboplatin AUC 2/week
Chemoradiation
Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w
Immunotherapy
4 cycles of induction therapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks followed by traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week (or carboplatin AUC 2/week) with concurrent nivolumab 240mg every 2 weeks.
Nivolumab 40 mg in 4 ml Injection
Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation
Ipilimumab 200 MG in 40 ML Injection
Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation
Chemoradiation
Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w
Interventions
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Nivolumab 40 mg in 4 ml Injection
Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation
Ipilimumab 200 MG in 40 ML Injection
Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation
Chemoradiation
Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
95 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Brava
INDUSTRY
Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Principal Investigators
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Fernando Maluf, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Israelita Albert Einstein
Locations
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CRIO -Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Clinica AMO
Salvador, Estado de Bahia, Brazil
Hospital das Clinicas da UFMG
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Multi Oncoclinicas Recife
Recife, Pernambuco, Brazil
Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Federal de Roraima
Boa Vista, Roraima, Brazil
CEPON - Florianópolis
Florianópolis, Santa Catarina, Brazil
Hospital de Amor
Barretos, São Paulo, Brazil
Hospital De Base de São José do Rio Preto - CIP São José
São José do Rio Preto, São Paulo, Brazil
INCA - Instituto Nacional do Cancer
Rio de Janeiro, , Brazil
AC Camargo Cancer Center
São Paulo, , Brazil
Hospital Municipal Vila Santa Catarina
São Paulo, , Brazil
Hospital Israelita Albert Einstein
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Fernando Maluf
Role: primary
References
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Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.
Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, Lopez-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN. Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial. J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.
Santin AD, Deng W, Frumovitz M, Buza N, Bellone S, Huh W, Khleif S, Lankes HA, Ratner ES, O'Cearbhaill RE, Jazaeri AA, Birrer M. Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002). Gynecol Oncol. 2020 Apr;157(1):161-166. doi: 10.1016/j.ygyno.2019.12.034. Epub 2020 Jan 7.
Other Identifiers
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BRAVA- Cervical - SGPP 5031-21
Identifier Type: -
Identifier Source: org_study_id
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