Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Launched by HOSPITAL ISRAELITA ALBERT EINSTEIN · Aug 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment approaches for women with locally advanced cervical cancer. Specifically, it compares standard treatment with chemoradiation, which involves chemotherapy and radiation, to a new combination of two medications (nivolumab and ipilimumab) followed by the same standard chemoradiation. Researchers want to find out if the new treatment can help patients live without cancer for longer, measured by how many patients are disease-free after three years.

To be eligible for this trial, participants need to be women over 18 years old with specific types of cervical cancer that have not been treated before. They should have a certain performance level, meaning they are generally healthy enough to participate. However, some women may not qualify, such as those who have had previous treatments or certain health conditions. If a woman joins the trial, she can expect to receive either the standard treatment or the new medication approach, and she will be closely monitored by the study team throughout the process. This trial is currently recruiting participants, so it’s a good opportunity for eligible patients to contribute to important cancer research.

Gender

FEMALE

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 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