Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
ConditionUterine Cervical Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-95
SponsorHospital Israelita Albert Einstein
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nivolumab 40 mg in 4 ml Injection
DrugNivolumab 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
DrugIpilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation
Chemoradiation
RadiationRadiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Standard ChemoradiationActive comparator 1 intervention
Group B: ImmunotherapyExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
3-year progression-free survival
No evidence of disease recurrence/regrowth after 3 years of follow-up
Time frame
3 yearsSecondary outcomes
1
3-year overall survival
Rate of survival 3 years after the end of chemoradiation
Time frame
3 years2
Objective response rate
RECIST response
Time frame
90 days after the end of chemoradiation3
Response duration
Time from maximum response to disease progression
Time frame
Through study completion, an average of 3 year4
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).Sponsors and contacts
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Source ClinicalTrials.gov