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
Qualifiers
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
Treatments tested in this trial
- Nivolumab 40 mg in 4 ml Injection
- Ipilimumab 200 MG in 40 ML Injection
- Chemoradiation
Treatment groups
112 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov