Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT07336147
Phase
PHASE2
Status
Recruiting
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Conditions

  • Female

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    The 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.

Study Details

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

Key Dates

Start date
Dec 22, 2025
Status verified
Jan 2026
Primary completion
Dec 22, 2027
Completion
Dec 22, 2030

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: dostarlimab
    The 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.

Primary Outcome Measure

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 [ Time Frame: 588 DAYS ]

Central Contacts

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