FemalePhase 2NCT07336147
Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma
A Phase 2 study testing Dostarlimab in people with Female, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Female
- What is being tested?
- Dostarlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Dec 2025to 22 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
- 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.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
Who cannot join
- 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.
- Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
- 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.
- Has received radical surgery for cervical cancer.
Show all 24Show fewer
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- Has severe hypersensitivity (≥Grade 3) to dostarlimab and/or any of its excipients.
- Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.
- Has a known history of untreated Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection (for those with anti-HCV+, patients who ever HCV RNA positive should undergo 8-12 weeks direct acting agents (DAA) treatment and confirmed with HCV cure, defined as HCV RNA negative at week 12 post end-of-treatment). Note: Testing for Hepatitis B and Hepatitis C is required but the patient is eligible if well controlled.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Allergy: Participant cannot have history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies or fusion proteins, sensitivity to any of the study treatments or components thereof, or a history of drug or other allergy that contraindicates their participation.
- Has had an allogenic tissue/solid organ transplant.
- Participant has received a live vaccine within 30 days of planned start of study therapy. COVID-19 vaccines that do not contain live viruses are allowed. Note: mRNA and adenoviral-based COVID-19 vaccines are considered non-live.
- Participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
- Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan, 333
CHYONG-HUEY CHL LAI, M.D., +88633281200#8254, laich46@cgmh.org.tw
About this study
Official title: Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma (DICER Trial): Taiwanese Gynecologic Oncology Group (TGOG) 1012
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
- Conditions
- Female
- Being tested
- Dostarlimab
- Keywords
- dostarlimab, cisplatin, etoposide, cervical carcinoma
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
Also called etoposide, cisplatin, radiotherapy
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 group | Role | What they receive |
|---|---|---|
| dostarlimab | Experimental | 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. Receives: Drug: Dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 588 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start22 Dec 2025
- Primary completion22 Jun 2028 (estimated)
- Study completion22 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwanese Gynecologic Oncology Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336147
- Sponsor's protocol ID
- 202501489A0
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma (DICER Trial): Taiwanese Gynecologic Oncology Group (TGOG) 1012
- ClinicalTrials.gov ID
- NCT07336147
- Acronym / sponsor ID
- 202501489A0
- Conditions
- Female
- Keywords
- dostarlimab, cisplatin, etoposide, cervical carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Taiwanese Gynecologic Oncology Group
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 22 Jun 2028 (estimated)
- Study completion
- 22 Dec 2030 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dostarlimab | Experimental | Drug: DostarlimabThe 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
- 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.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
Key exclusion criteria (24 listed)
- 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.
- Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabAlso: etoposide, cisplatin, radiotherapyThe 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. | Drug | dostarlimab |
Primary outcome
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
Add-on dostarlimab to chemoradiation with etoposide and cisplatin can prolong OS with acceptable tolerability and maintaining quality of life (QOL).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Related trials for Female
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dostarlimab in people with Female, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHYONG-HUEY CHL LAI (+88633281200#8254, laich46@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.