Clinical trial · Interventional
Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia
Phase 2 Single Agent Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia (GTN)
NCT05405192CI-TRIAL-00064315withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI is leaving the University.
Summary
Brief summary (as posted)
The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gestational Trophoblastic Neoplasia | Gestational Trophoblastic Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dostarlimab | Drug | Dostarlimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dostarlimab Group
- description
- Participants will receive a total of up to 20 cycles of Dostarlimab: 4 cycles of Dostarlimab at a dose of 500 mg on day 1 of each of the 21-day cycle and 16 cycles of Dostarlimab at a dose of 1000 mg on day 1 of each of the 42-day cycle.
- interventionNames
- Drug: Dostarlimab
Primary outcomes (1)
- measure
- Proportion of patients with successful normalization of beta hCG
- timeFrame
- Up to 24 months
- description
- Proportion of patients with a successful normalized serum human chorionic gonadotropin (hCG) level (complete response) as measured by serum samples.
Secondary outcomes (4)
- measure
- Proportion of patients with objective response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease 2. Female patients \>18 years old. 3. Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient. 4. Patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or fatigue). Exclusion Criteria: 1. Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody 2. Participant must not be simultaneously enrolled in any interventional clinical trial. 3. Participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects. 4. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.