Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Phase 2RecruitingNCT05492123

Hospital Israelita Albert Einstein112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Uterine Cervical Neoplasms

Interventions

Nivolumab 40 mg in 4 ml InjectionDRUG

Nivolumab 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 InjectionDRUG

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

ChemoradiationRADIATION

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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 status of 0-1 * At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline. Exclusion Criteria: * 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. * History of allogeneic organ transplantation * Active or prior documented autoimmune or inflammatory disorders * Uncontrolled intercurrent illness * History of another primary malignancy and active primary immunodeficiency * Patients with active infection Laboratory values that fall into: 1. WBC count (WBC) \< 2000/μL ; 2. Neutrophil count \< 1500/μL; 3. Platelet count \< 100 x 103/μL; 4. Hemoglobin level \< 9.0 g/dL; 5. 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); 6. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): \> 3.0 x ULN; 7. Total bilirubin \> 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0 x ULN); 8. 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). * Participants with a condition requiring systemic treatment or with corticosteroids (\>10 mg daily of a prednisone equivalent) or other immunosuppressive drugs within 14 days of initiating study treatment. * Pregnant or breastfeeding woman

Locations (14)

CRIO -Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

RECRUITING

Clinica AMO

Salvador, Estado de Bahia, Brazil

Outcomes

Primary Outcomes

3-year progression-free survival

No evidence of disease recurrence/regrowth after 3 years of follow-up

Time frame: 3 years

Secondary Outcomes

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).

Central Contacts

Diogo Bugano, MD

CONTACT

+55-11-2151-0240 diogo.gomes@einstein.br

Data from ClinicalTrials.gov

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