Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Low dose Nivolumab, Neoadjuvant Carboplatin, Neoadjuvant Paclitaxel, Concurrent Chemoradiation: 20mg Nivolumab two doses three week apart with neoadjuvant chemotherapy.
Neoadjuvant che
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1 Histologically confirmed FIGO stage IIIC-IVa squamous, adeno or adenosquamous carcinoma of the cervix 2 Deemed suitable and fit for radical chemoradiation. 3 Medically fit to receive carboplatin and paclitaxel. 4 ECOG performance status 0 – 1 5 Aged 18 and over
Exclusion criteria
Exclusion criteria: 1 Presence of locally advanced disease who is not fit for radical chemoradiation 2 Participants with more than or equal to Grade 2 peripheral neuropathy 3 Participants with an active, known or suspected autoimmune disease 4 Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment 5 Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 To determine the overall response rate to neoadjuvant chemoimmunotherapy according to RECIST 1.1.Timepoint: 12 weeks after completion of all treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To assess response rates 12 weeks after completing all treatment 2 Patterns of first relapse 3 To determine the Progression Free survival and overall survival. 4 To determine adverse events according to CTCAEv5.0. 5 To assess the Quality of Life Timepoint: 12 weeks after completing all treatment | — |
Countries
India
Contacts
Public ContactDr Saurabh Sharma
AIIMS, New Delhi
Outcome results
None listed