Trial · NCT06278857
SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)
NCT06278857, Phase 2, Recruiting, Queensland Centre for Gynaecological Cancer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr). Trials, record NCT06278857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06278857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)
- NCT number
- NCT06278857
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Conditions
- Endometrial Cancer Stage I, Mmr Deficiency, Endometrioid Endometrial Adenocarcinoma, Immune-related Adverse Event
- Interventions
- Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]
- First posted
- 2024-02-26
- Last updated
- 2024-12-03
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab. | Week 27 (Month 6) | Number of participants achieving investigator-assessed pathological complete response (pCR). |
| Secondary | Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma. | From Cycle 1 /Day 1 to 30 days post last dose, 9 and 12months. | Safety analyses including incidence of treatment-emergent adverse events (TEAEs), immune-related AEs of interest (irAEIs), and serious adverse events (SAEs), toxicities graded 3-5 as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0). |
| Secondary | TEAEs/irAEIs Leading to Study Drug Discontinuation | Screening to Cycle 7 (Week 25) | Explore the frequency and severity of TEAEs/irAEIs that lead to discontinuation of the study drug. |
| Secondary | TEAEs/irAEIs Leading to Study Withdrawal | From Screening to Week 27 (6 months) 9 and 12months. | Investigate and assess the frequency and severity of TEAEs/irAEIs resulting in the withdrawal of participants from the study. |
| Secondary | Clinically Significant Changes in Haematology | From Screening to Week 27 (6 months) 9 and 12months to End of Study. | Assess the number of participants with clinically significant changes in Haematology |
| Secondary | Clinically Significant Changes in Clinical Chemistry | From Screening to Week 27 (6 months) 9 and 12months to End of Study. | Assess the number of participants with clinically significant changes in Clinical Chemistry |
| Secondary | Clinically Significant Changes in Thyroid Function | From Screening to Week 27 (6 months) | Assess the number of participants with clinically significant changes in Thyroid Function (Measure thyroid-stimulating hormone (TSH), free thyroxine (FT4), and triiodothyronine (T3) levels.) |
| Secondary | Abnormal Vital Signs | From Screening to Week 27 (6 months) 9 and 12months. | Assess the number of participants with abnormal vital signs pre and post treatment. |
| Secondary | Abnormal Electrocardiogram (ECG) Parameters | Screening, Week 12 (3 months) and Week 27 (6 months) | Asses the number of participants with abnormal ECG parameters. |
| Secondary | Clinically Significant Abnormal Physical Examination | From screening visit to Week 27 (6 months), 9 and 12 months | Assess the number of participants with clinically significant abnormal physical examinations. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39955187 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06278857
GET https://conductscience.org/api/trials/v1/NCT06278857/registered?page=2