Combining immunotherapy and chemoradiation for advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves 112 patients with locally advanced cervical cancer who will be randomly assigned to receive either standard cisplatin-based chemoradiation or a combination of nivolumab and ipilimumab followed by chemoradiation. The study aims to evaluate the effectiveness of this immunotherapy approach in improving disease-free survival rates. Participants will receive four cycles of nivolumab and ipilimumab before undergoing chemoradiation, with the primary outcome being the rate of progression-free survival after three years.

Why it matters

Who can join: the full rules

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

Where it's running

• CRIO -Centro Regional Integrado de Oncologia
  Fortaleza, Ceará, Brazil Recruiting
• Clinica AMO
  Salvador, Estado de Bahia, Brazil Recruiting
• Multi Oncoclinicas Recife
  Recife, Pernambuco, Brazil Recruiting
• Universidade Federal de Roraima
  Boa Vista, Roraima, Brazil Recruiting
• Hospital Municipal Vila Santa Catarina
  São Paulo, Brazil Recruiting
• Hospital Israelita Albert Einstein
  São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Fernando Maluf, MD — Hospital Israelita Albert Einstein
• Study coordinator: Diogo Bugano, MD
• Email: diogo.gomes@einstein.br
• Phone: +55-11-2151-0240

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.