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Monoclonal Antibodies

Dostarlimab for Gestational Trophoblastic Neoplasia

Phase 2
Waitlist Available
Led By Marilyn Huang, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial will test if Dostarlimab is an effective treatment for GTN, a cancer that affects pregnant women.

Eligible Conditions
  • Gestational Trophoblastic Neoplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with successful normalization of beta hCG
Secondary outcome measures
Number of Participants with treatment related-adverse events
Overall survival (OS)
Progression-free survival (PFS)
+1 more

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04409002
80%
Anemia
80%
Fatigue
73%
Abdominal pain
67%
CD4 lymphocytes decreased
67%
Alkaline phosphatase increased
67%
Nausea
60%
Anorexia
60%
Constipation
53%
Platelet count decreased
53%
Hyperglycemia
47%
Thromboembolic event
47%
Weight loss
47%
Anxiety
47%
Hypoalbuminemia
40%
Vomiting
40%
Peripheral motor neuropathy
40%
Blood bilirubin increased
40%
Dyspnea
40%
Hypertension
33%
Edema limbs
33%
Abdominal distension
33%
Aortic valve disease
33%
Back pain
33%
Diarrhea
33%
Fever
33%
Hypocalcemia
33%
Sinus tachycardia
27%
Depression
27%
White blood cell decreased
27%
Chills
27%
Ascites
27%
Hyponatremia
20%
Pain
20%
Urine discoloration
20%
Paresthesia
20%
Sore throat
20%
Delirium
20%
Cough
20%
Dizziness
20%
Lymphocyte count decreased
13%
Insomnia
13%
Palpitations
13%
Thrush
13%
Pain in extremity
13%
Neutrophil count decreased
13%
Confusion
13%
Dehydration
13%
Fall
13%
Cardiac troponin T increased
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Bloating
13%
Dry mouth
13%
Dysphagia
13%
Dysuria
13%
Flatulence
13%
Gastroesophageal reflux disease
13%
Glucosuria
13%
Hiccups
13%
Hypercalcemia
13%
Hyperkalemia
13%
Hypokalemia
13%
Hypophosphatemia
13%
Hypothyroidism
13%
Localized edema
7%
Skin ulceration
7%
Oral pain
7%
Obesity
7%
Oral hemorrhage
7%
Encephalopathy
7%
Generalized muscle weakness
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Osteoporosis
7%
Urinary retention
7%
Papulopustular rash
7%
Skin infection
7%
Endocarditis infective
7%
Erectile dysfunction
7%
Hematuria
7%
Stroke
7%
Thyroid stimulating hormone increased
7%
Hemorrhoidal hemorrhage
7%
Urinary frequency
7%
Superficial thrombophlebitis
7%
Tremor
7%
Eye disorders - Other, specify
7%
Pelvic pain
7%
Prostatic obstruction
7%
Pruritus
7%
Rash acneiform
7%
Rectal pain
7%
Renal calculi
7%
Reproductive system and breast disorders - Other, specify
7%
Wheezing
7%
Portal vein thrombosis
7%
Vaginal dryness
7%
Alopecia
7%
Arthralgia
7%
Arthritis
7%
Bacteremia
7%
Biliary tract infection
7%
Blood lactate dehydrogenase increased
7%
Buttock pain
7%
Dry skin
7%
Dysgeusia
7%
Flank pain
7%
Gastric anastomotic leak
7%
Gastric ulcer
7%
Gastritis
7%
Gastrointestinal disorders - Other, specify
7%
Gastrointestinal pain
7%
Hyperlipidemia
7%
Hypoglycemia
7%
Lethargy
7%
Memory impairment
7%
Mucositis oral
7%
Muscle cramp
7%
Muscle weakness lower limb
7%
Myocarditis
7%
Restlessness
7%
Scleral disorder
7%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Niraparib+Dostarlimab + Radiation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dostarlimab GroupExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 2
~1000

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,452 Total Patients Enrolled
University of MiamiLead Sponsor
898 Previous Clinical Trials
409,651 Total Patients Enrolled
Marilyn Huang, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
53 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is Dostarlimab a secure option for individuals?

"Dostarlimab is estimated to be moderately safe, as it currently sits at a score of 2. This can be attributed to the fact that this drug has gone through Phase 2 trials and there exists limited data suggesting its efficacy."

Answered by AI

Is there an ongoing need for human volunteers in this research endeavor?

"According to information held on clinicaltrials.gov, this trial has concluded participant recruitment and no longer seeks patients. The study was first publicised on March 1st 2023 with the last data update occurring November 4th 2022. However 2378 other trials are still open for enrolment at present."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
University of Miami Sylvester Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia
2023. "Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05405192.
~0 spots leftby Dec 2026
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