A Phase 2 interventional study of Nivolumab 40 mg in 4 ml Injection and Ipilimumab 200 MG in 40 ML Injection in Uterine Cervical Neoplasms, sponsored by Hospital Israelita Albert Einstein. Recruiting at 14 sites in Brazil. Open to female participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Hospital Israelita Albert Einstein · Phase 2, Interventional, and Treatment
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 112 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laboratory values that fall into:
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);
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).
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
Radiation: Chemoradiation
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.
Drug: Nivolumab 40 mg in 4 ml Injection · Drug: Ipilimumab 200 MG in 40 ML Injection · Radiation: Chemoradiation
Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation
Also known as: Opdivo
Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation
Also known as: Yervoy
Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w
Also known as: Cisplatin-based chemoradiation
3-year progression-free survival
No evidence of disease recurrence/regrowth after 3 years of follow-up
Time frame: 3 years
3-year overall survival
Rate of survival 3 years after the end of chemoradiation
Time frame: 3 years
Objective response rate
RECIST response
Time frame: 90 days after the end of chemoradiation
Response duration
Time from maximum response to disease progression
Time frame: Through study completion, an average of 3 year
To evaluate health related quality of life (HRQoL): defined as the change from baseline of disease-related symptoms and quality of life of patients undergoing treatment Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Evaluate health related quality of life using the instrument EORTC QLQ-C30 v3 based on European Organization for Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 v3 questionnaire, consisting of 30 questions covering 15 domains, divided into three distinct scales: state scale global health and quality of life (it has only one domain, global health measure); functional scale (physical function, role performance, emotional function, cognitive function and social function domains); and symptom scale (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea and financial difficulties). The scores on each scale range from 0 - 100. The global and functional health scales indicate better quality of life as their score approaches 100. For the symptoms scale, the analysis is inverse, with better performance for quality of life when the scores approach the score minimum (zero).
Time frame: Baseline (time from screening - before starting treatment) and at the end of treatment (56 days after the last dose of radiotherapy).
Evaluate health related quality of life using supplemental cervical cancer module (EORTC CX24) to evaluate patients submitted to treatment with Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer.
The EORTC - CX24 questionnaire contains 24 questions, divided into three multiple-item scales and six single-item scales, of which 11 refer to symptoms (questions 31-37, 39 and 41-43), three about body image. (questions 45-47), four questions on sexual/vaginal function (questions 50-53), one on lymphedema (question 38), one for evaluation of peripheral neuropathy (question 40), one for evaluation of menopausal symptoms (question 44) ), one on sexual concerns (question 48), one on sexual activity (question 49) and one on sexual pleasure (question 54). The answers are transformed into a score from 0 - 100 and calculated separately for each scale.
Time frame: Baseline (time from screening - before starting treatment) and at the end of treatment (56 days after the last dose of radiotherapy).
Treatment-related toxicity
Treatment-related toxicity according to CTCAE version 4.0 (Common Toxicity Criteria for Adverse Events )
Time frame: Through study completion, an average of 3 year
Plan to share: No
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Hospital Israelita Albert Einstein