Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

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.

Eligibility

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

Conditions2

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