CTRI/2024/07/071051
Not yet recruiting
Phase 2
ow dose Nivolumab in combination with Neoadjuvant Chemotherapy followed by concurrent Chemoradiation in advanced Carcinoma Cervix: A phase II study - NI
ICMR0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Sponsor
- ICMR
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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