Gestational Trophoblastic NeoplasiaPhase 2NCT05405192
Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia
A Phase 2 study testing Dostarlimab in people with Gestational Trophoblastic Neoplasia, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Trophoblastic Neoplasia
- What is being tested?
- Dostarlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease
- Female patients >18 years old.
- Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient.
- Patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or fatigue).
Who cannot join
- Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody
- Participant must not be simultaneously enrolled in any interventional clinical trial.
- Participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: Phase 2 Single Agent Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia (GTN)
The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).
- Conditions
- Gestational Trophoblastic Neoplasia
- Being tested
- Dostarlimab
- Medical subject headings
- Gestational Trophoblastic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
First four cycles of Dostarlimab will be given intravenously (IV) on day 1 of each of the 21-day cycle at a dose of 500 milligrams (mg). The next 16 cycles of Dostarlimab will be given on day 1 of each of the 42-day cycles at a dose of 1,000 mg.
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab Group | Experimental | 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. Receives: Drug: Dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with successful normalization of beta hCG
Proportion of patients with a successful normalized serum human chorionic gonadotropin (hCG) level (complete response) as measured by serum samples.
Measured: Up to 24 months
Secondary outcomes (4)
Proportion of patients with objective response rate (ORR)
ORR is defined as achieving best response of complete or partial responses (CR or PR) as assessed via Response Evaluated Criteria in Solid Tumors (RECIST)
Measured: Up to 25 months
Number of Participants with treatment related-adverse events
Non-hematological Grade 3 and higher treatment-related adverse events as evaluated by treating physician using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Measured: Up to 25 months
Progression-free survival (PFS)
PFS is the elapsed time from the date of treatment initiation to date of first documentation of progression (or recurrence) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last documented progression-free status.
Measured: Up to 48 months
Overall survival (OS)
OS is the elapsed time from treatment initiation to death. For alive patients, OS will be censored at the date last known to be alive.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Why it stopped: PI is leaving the University.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Trophoblastic NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Marilyn Huang, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405192
- Sponsor's protocol ID
- 20210967
- Status last verified
- Feb 2023
- First submitted
- 26 May 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Single Agent Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia (GTN)
- ClinicalTrials.gov ID
- NCT05405192
- Acronym / sponsor ID
- 20210967
- Conditions
- Gestational Trophoblastic Neoplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is leaving the University.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 6 Jun 2022 (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.
The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab Group | Experimental | Drug: DostarlimabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease
- Female patients >18 years old.
- Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient.
- Patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or fatigue).
Key exclusion criteria (4 listed)
- Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody
- Participant must not be simultaneously enrolled in any interventional clinical trial.
- Participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- 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.
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 |
|---|---|---|
| DostarlimabFirst four cycles of Dostarlimab will be given intravenously (IV) on day 1 of each of the 21-day cycle at a dose of 500 milligrams (mg). The next 16 cycles of Dostarlimab will be given on day 1 of each of the 42-day cycles at a dose of 1,000 mg. | Drug | Dostarlimab Group |
Primary outcome
Proportion of patients with successful normalization of beta hCG
Time frame: Up to 24 months
Proportion of patients with a successful normalized serum human chorionic gonadotropin (hCG) level (complete response) as measured by serum samples.
4 secondary outcomes
Proportion of patients with objective response rate (ORR)
Time frame: Up to 25 months
Number of Participants with treatment related-adverse events
Time frame: Up to 25 months
Progression-free survival (PFS)
Time frame: Up to 48 months
Overall survival (OS)
Time frame: Up to 48 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marilyn Huang, MD principal investigator
University of Miami
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 Gestational Trophoblastic Neoplasia, run by University of Miami at 1 site in United States.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 28 Feb 2023. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with successful normalization of beta hCG (time frame: Up to 24 months). 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 28 Feb 2023.