Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Brazil
Hospital de Amor
NOT_YET_RECRUITING
Barretos
Hospital das Clinicas da UFMG
NOT_YET_RECRUITING
Belo Horizonte
Universidade Federal de Roraima
RECRUITING
Boa Vista
Hospital Erasto Gaertner
NOT_YET_RECRUITING
Curitiba
CEPON - Florianópolis
NOT_YET_RECRUITING
Florianópolis
CRIO -Centro Regional Integrado de Oncologia
RECRUITING
Fortaleza
Hospital São Lucas - PUCRS
NOT_YET_RECRUITING
Porto Alegre
Multi Oncoclinicas Recife
RECRUITING
Recife
INCA - Instituto Nacional do Cancer
NOT_YET_RECRUITING
Rio De Janeiro
Clinica AMO
RECRUITING
Salvador
Hospital De Base de São José do Rio Preto - CIP São José
NOT_YET_RECRUITING
São José Do Rio Preto
AC Camargo Cancer Center
NOT_YET_RECRUITING
São Paulo
Hospital Israelita Albert Einstein
RECRUITING
São Paulo
Hospital Municipal Vila Santa Catarina
RECRUITING
São Paulo
Contact Information
Primary
Diogo Bugano, MD
diogo.gomes@einstein.br
+55-11-2151-0240
Time Frame
Start Date: 2022-08-30
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 112
Treatments
Active_comparator: 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
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb, Brava
Leads: Hospital Israelita Albert Einstein