Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Recruiting Phase 2 Interventional Study
Uterine Cervical Neoplasms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 95
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
112 (estimated)
Sponsor
Hospital Israelita Albert Einstein · Other
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 sta…
Contacts

Diogo Bugano, MD

+55-11-2151-0240

diogo.gomes@einstein.br

CONTACT