Actively Recruiting
SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)
Led by Queensland Centre for Gynaecological Cancer · Updated on 2024-12-03
10
Participants Needed
3
Research Sites
204 weeks
Total Duration
On this page
Sponsors
Q
Queensland Centre for Gynaecological Cancer
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions. Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks. This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.
CONDITIONS
Official Title
SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participant aged 18 years or older at the time of consent
- Histologically or cytologically confirmed Stage 1, FIGO grade 1 or 2, MMR deficient endometrioid endometrial adenocarcinoma
- Desire to preserve uterus or not suitable for hysterectomy
- ECOG performance status of 2 or less
- No evidence of disease outside the uterus based on clinical and imaging assessments
- Adequate organ and bone marrow function (specific blood count and liver, kidney, coagulation parameters)
- Potential for one rescreen if clinical or lab abnormalities are present but deemed safe by investigator
- Women of child-bearing potential must have negative pregnancy test and use effective contraception during and 4 months after treatment
- Post-menopausal status confirmed by follicle-stimulating hormone levels for amenorrhoeic women
- Well-controlled type I or II diabetes with HbA1c below 8.5% and willingness to monitor blood glucose
- Normal or controlled blood pressure
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- Non-endometrioid histology such as sarcomas or high-risk types (papillary serous, clear cell)
- Pregnant, breastfeeding, or planning pregnancy during the trial
- History of allogeneic tissue or solid organ transplant
- Uncontrolled hypertension or severe cardiovascular disease, including recent arrhythmias or heart failure
- Poor medical risk due to uncontrolled disorders or active infections requiring recent IV antibiotics
- Immunodeficiency or recent use of significant systemic steroids or immunosuppressants
- Active autoimmune disease requiring systemic treatment in past 2 years
- Recent COVID-19 or influenza infection within 3 months
- Blood transfusion within 21 days before first dose
- Major surgery within 4 weeks before consent
- Prior severe immune-related adverse events from immunotherapy
- Participation in another investigational trial within 30 days or 5 half-lives except hormonal IUD
- Concomitant malignancy or prior non-endometrial invasive malignancy unless disease-free for 5 years
- Known HIV infection or positive test at screening
- Active Hepatitis B or C without complete cure
- Hypersensitivity to study drug or excipients
- History or current diagnosis of interstitial lung disease
- Receipt or planned receipt of live vaccine within 30 days before or during treatment and up to 180 days after last dose
- Unable or unwilling to follow protocol or attend follow-up visits
- Any condition contraindicating required tumor or blood sampling procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Not Yet Recruiting
2
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Actively Recruiting
3
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
S
Sara Baniahmadi
CONTACT
V
Vanessa Behan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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