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Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

NCT05492123 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-01-05

No results posted yet for this study

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.

Conditions

  • Uterine Cervical Neoplasms

Interventions

DRUG

Nivolumab 40 mg in 4 ml Injection

Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation

DRUG

Ipilimumab 200 MG in 40 ML Injection

Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation

RADIATION

Chemoradiation

Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Brava

    collaborator INDUSTRY

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Fernando Maluf, MD · Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2026-12-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05492123 on ClinicalTrials.gov