Combining immunotherapy and chemoradiation for advanced cervical cancer
Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer
This study is testing if adding two immunotherapy drugs to standard treatment can help people with advanced cervical cancer live longer without their disease getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | Female |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone, nivolumab, ipilimumab, immunotherapy |
| Locations | 14 sites (Fortaleza, Ceará and 13 other locations) |
| Trial ID | NCT05492123 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women over 18 with locally advanced cervical adenocarcinoma or squamous cell carcinoma who have not received prior chemotherapy or radiation.
Not a fit: Patients with small cell cervical cancer, those requiring fertility-sparing treatments, or with evidence of metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced cervical cancer.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in various cancers, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fortaleza, Ceará and 13 other locations
- CRIO -Centro Regional Integrado de Oncologia — Fortaleza, Ceará, Brazil (Recruiting)
- Clinica AMO — Salvador, Estado de Bahia, Brazil (Recruiting)
- Hospital das Clinicas da UFMG — Belo Horizonte, Minas Gerais, Brazil (Not_yet_recruiting)
- Hospital Erasto Gaertner — Curitiba, Paraná, Brazil (Not_yet_recruiting)
- Multi Oncoclinicas Recife — Recife, Pernambuco, Brazil (Recruiting)
- Hospital São Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil (Not_yet_recruiting)
- Universidade Federal de Roraima — Boa Vista, Roraima, Brazil (Recruiting)
- CEPON - Florianópolis — Florianópolis, Santa Catarina, Brazil (Not_yet_recruiting)
- Hospital de Amor — Barretos, São Paulo, Brazil (Not_yet_recruiting)
- Hospital De Base de São José do Rio Preto - CIP São José — São José do Rio Preto, São Paulo, Brazil (Not_yet_recruiting)
- INCA - Instituto Nacional do Cancer — Rio de Janeiro, Brazil (Not_yet_recruiting)
- AC Camargo Cancer Center — São Paulo, Brazil (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.