Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 2: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Paclitaxel + Carboplatin: Paclitaxel 60 mg/m IV weekly + Carboplatin AUC 2 IV weekly for 6 weeks
Intervention2: Paclitaxel, Carboplatin, Nivolumab: Participants in the experimental arm
Sponsors
Indian council of Medical research
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix FIGO 2018 stage III or IVA disease, without evidence of distant metastases beyond para aortic lymph nodes Female patients aged 18 to 70 years ECOG performance status 0 to 1 Adequate organ function defined as: ANC at least 1.5 x 10^9 per L, Platelet count at least 100 x 10^9 per L, Hemoglobin at least 9 g per dL, Total bilirubin not more than 1.5 x ULN, AST and ALT not more than 2.5 x ULN, Creatinine clearance at least 50 mL per min by Cockcroft Gault, Serum magnesium at least 1.5 mg per dL At least one measurable pelvic lesion or measurable nodal disease as per RECIST version 1.1 Negative pregnancy test at screening for women of childbearing potential Willingness to use effective contraception during study treatment and for 5 months after last nivolumab dose and 6 months after last chemotherapy or cisplatin dose Ability to provide written informed consent Willingness to comply with study procedures including providing tumour tissue and blood samples for translational research
Exclusion criteria
Exclusion criteria: Prior systemic therapy, radiotherapy, or major surgery for current cervical cancer Presence of distant metastatic disease beyond para aortic lymph nodes Active autoimmune disease requiring systemic treatment within past 2 years, history of pneumonitis, or active interstitial lung disease Known immunodeficiency or requirement for chronic systemic corticosteroids more than 10 mg prednisone equivalent daily or other immunosuppressive therapy Uncontrolled infection including active tuberculosis, uncontrolled hepatitis B or hepatitis C, or uncontrolled HIV infection (patients with HIV may be enrolled if on stable antiretroviral therapy, CD4 count more than 200 cells per microliter, and undetectable viral load as per local policy) Clinically significant cardiovascular disease including uncontrolled arrhythmia or myocardial infarction within past 6 months Pregnant or breastfeeding women Any other medical or psychiatric condition which in the opinion of the investigator would compromise the patient s ability to participate in the study or affect study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate superiority of the experimental strategy versus control by assessment of PFS.Timepoint: AT BASELINE, EVERY 3 MONTHS AFTER COMPLETION OF TREATMENT FOR 2 YEARS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: Time from randomisation to death from any cause. | — |
Countries
India
Contacts
Public ContactDrSachin Khurana
All India Insitute of Medical Sciences new Delhi
Outcome results
None listed