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New treatment option for Uterine Cervical Neoplasms
Official title Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
ClinicalTrials.gov ID: NCT05492123
What this study is testing
What is Nivolumab 40 mg in 4 ml Injection?
Nivolumab 40 mg in 4 ml Injection is an investigational medicine, being studied as a potential treatment for uterine cervical neoplasms.
Also referred to as Opdivo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 95, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- History of allogeneic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders
See the full eligibility 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.
- 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:
- WBC count (WBC) \< 2000/μL ;
- Neutrophil count \< 1500/μL;
- Platelet count \< 100 x 103/μL;
- Hemoglobin level \< 9.0 g/dL;
- 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);
- Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): \> 3.0 x ULN;
- Total bilirubin \> 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0 x ULN);
- 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-...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fortaleza, Ceará, Brazil
- Salvador, Estado de Bahia, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Curitiba, Paraná, Brazil
- Recife, Pernambuco, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Boa Vista, Roraima, Brazil
- Florianópolis, Santa Catarina, Brazil
- Barretos, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fortaleza, Ceará, Brazil; Salvador, Estado de Bahia, Brazil; Belo Horizonte, Minas Gerais, Brazil; Curitiba, Paraná, Brazil; Recife, Pernambuco, Brazil; Porto Alegre, Rio Grande do Sul, Brazil and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.