Add-on dostarlimab to chemoradiation with etoposide and cisplatin and radiotherapy can improve progression-free survival (PFS) compared with historical controls who were treated with chemoradiation alone in SCNECC
Female participants who are 20-70 years of age on the day of signing informed consent with histologically confirmed diagnosis of Previously untreated SCNECC IB2-IV or IB1 with LVSI or IVB with oligometastasis (only in one distant organ not more than 2 nodules which can be encompassed by RT) will be enrolled in this study.
Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
A WOCBP who agrees to participate this trial should be informed that after the protocol treatment the ovarian function and child-bearing potential will be permanently lost and she has to follow the contraceptive guidance in Appendix 3 after enrollment through neoadjuvant chemoimmuntherapy period till external beam radiotherapy (EBRT) commences.
Have provided archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archival tissue. At least 5 punch biopsiesdof 3mm in diameter.
A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Has received prior systemic anti-cancer therapy for SCNECC including investigational agents prior to enrollment.
Has received prior pelvic radiotherapy.
Single group
Dostarlimab
DrugThe planned dose of dostarlimab for this study is 500 mg every 3 weeks (Q3W) during chemoimmunotherapy phase. Based on the totality of data generated in the dostarlimab development program, either 500 mg Q3W or 1000 mg Q6W is the appropriate dose of dostarlimab for adults across all indications and regardless of tumor type.
Dostarlimab, with radiotherapy in sandwich sequence for small cell neuroendocrine cervical carcinoma. PFS at 2 years (from 57% to 75%) PFS is defined the date of starting chemotherapy with dostarlimab to the date of progression defined with RECIST 1.1
Add-on dostarlimab to chemoradiation with etoposide and cisplatin can prolong OS with acceptable tolerability and maintaining quality of life (QOL).
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Chang Gung Memorial Hospital
Lead sponsor
Taiwanese Gynecologic Oncology Group
Collaborator
