Actively Recruiting
Dostarlimab, Cisplatin and Etoposide Combined With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma (DICER Trial) by Taiwanese Gynecologic Oncology Group
Led by Chang Gung Memorial Hospital · Updated on 2026-01-14
45
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of dostarlimab to chemoradiation with etoposide, cisplatin, and radiotherapy for treating small cell neuroendocrine cervical carcinoma (SCNECC). This phase 2 trial aims to improve progression-free survival compared to historical treatments of chemoradiation alone. The study focuses on female patients with untreated SCNECC, exploring whether the combined approach improves outcomes. Participants will receive dostarlimab at a dose of 500 mg every 3 weeks during the chemoimmunotherapy phase. This treatment is combined with cisplatin, etoposide, and radiotherapy given in a sandwich sequence. The dosing schedule is based on existing data supporting these doses for adults across tumor types. The study treatment will be administered over a planned period with careful monitoring. During the study, participants will undergo evaluations including performance status assessments and tumor biopsies. Researchers will monitor progression-free survival over 2 years, defined from the start of chemotherapy with dostarlimab to disease progression per RECIST 1.1 criteria. Safety and treatment effects will be tracked, with participants followed closely throughout the treatment and observation periods, which may extend up to several years.
CONDITIONS
Brief Title
Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 20 to 70 years at the time of informed consent
- Histologically confirmed diagnosis of previously untreated small cell neuroendocrine cervical carcinoma (SCNECC) stages IB2-IV or IB1 with lymphovascular space invasion or IVB with limited metastasis
- Not pregnant or breastfeeding and either not a woman of childbearing potential or agrees to follow contraceptive guidance
- Provided archival or newly obtained tumor tissue sample for analysis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first treatment dose
You will not qualify if you...
- Positive pregnancy test within 72 hours prior to allocation
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor targeted agents
- Prior systemic anti-cancer therapy for SCNECC including investigational treatments
- Previous pelvic radiotherapy or radical surgery for cervical cancer
- Receipt of live or live-attenuated vaccine within 30 days before first study drug dose
- Participation in another investigational study within 4 weeks before first dose
- Diagnosis of immunodeficiency or use of immunosuppressive therapy within 7 days before first dose
- Active or progressing additional malignancy requiring treatment in past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to dostarlimab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known history of HIV infection
- Untreated Hepatitis B or active Hepatitis C infection without confirmed cure
- Conditions or abnormalities that could interfere with study participation
- History of severe allergic reactions contraindicating participation
- Prior allogenic tissue or organ transplant
- Cirrhosis or unstable liver or biliary disease as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 19 months (588 days) from start of chemotherapy
Participants receive dostarlimab combined with cisplatin, etoposide, and radiotherapy in a sandwich sequence to treat small cell neuroendocrine cervical carcinoma.
Visits every 3 weeks during chemoimmunotherapy phase
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan, Taiwan, 333
Actively Recruiting
Research Team
C
CHYONG-HUEY CHL LAI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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