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Tests treatment safety and results for Endometrial Cancer Stage I
Official title SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)
ClinicalTrials.gov ID: NCT06278857
What this study is testing
What is Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]?
Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI] is an investigational medicine, given as an once-weekly, being studied as a potential treatment for endometrial cancer stage i.
Also referred to as JEMPERLI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female participant is at least 18 years of age (at the time of informed consent).
- Participant has: i. histologically or cytologically proven Stage 1, FIGO grade 1 or 2, MMR deficient (Absence of at least one MMR protein (MLH1...
- Participant has an ECOG performance status of ≤ 2
- Participant demonstrates no evidence of extrauterine disease assessed from all available clinical evidence (physical examination findings) and...
- Participants must have adequate organ and bone marrow function defined as: i. absolute neutrophil count 1.5 x 109/L ii. platelets 100 x 109/L iii...
You likely can't join if
- Participant has a histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high-risk endometrial e.g., papillary serous, clear...
- Participant is pregnant, breastfeeding, or planning to become pregnant during the trial period.
- Participant has had an allogeneic tissue/solid organ transplant.
- Participants with uncontrolled hypertension, history of hypertension crisis, history of hypertensive encephalopathy, QTc\>450 at baseline, other...
- Participant is considered a poor medical risk due to an uncontrolled medical disorder, non-malignant systemic disease, or active infection...
- Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or...
See the full eligibility criteria
Who can join
- Female participant is at least 18 years of age (at the time of informed consent).
- Participant has: i. histologically or cytologically proven Stage 1, FIGO grade 1 or 2, MMR deficient (Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry.) endometrioid endometrial...
- Participant has an ECOG performance status of ≤ 2
- Participant demonstrates no evidence of extrauterine disease assessed from all available clinical evidence (physical examination findings) and medical imaging including standard of care diagnostic CT, MRI, ultrasound...
- Participants must have adequate organ and bone marrow function defined as: i. absolute neutrophil count 1.5 x 109/L ii. platelets 100 x 109/L iii. haemoglobin ≥9 g/dL Adequate liver function: iv. total bilirubin \ 30...
- A potential participant with a clinical abnormality or laboratory parameters outside the normal reference range for the population being studied may be rescreened once, at the Investigator's discretion, and may be...
- Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at enrolment prior to each treatment cycle and use a highly effective contraceptive method including; oral contraceptive pills [OCPs]...
- Post-menopausal females. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (≥ 40 IU/mL) at screening for amenorrhoeic (≥ 12 months) female participants.
- Participants with confirmed Type I or Type II diabetes mellitus must be well controlled by medication and/or diet and have glycated haemoglobin (HBAc1) \< 8.5% at screening and be willing to monitor blood glucose levels...
- Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension.
- Participant is able to provide written informed consent and are willing to participate for the duration of the study and to follow study procedures.
What rules you out
- Participant has a histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high-risk endometrial e.g., papillary serous, clear cell).
- Participant is pregnant, breastfeeding, or planning to become pregnant during the trial period.
- Participant has had an allogeneic tissue/solid organ transplant.
- Participants with uncontrolled hypertension, history of hypertension crisis, history of hypertensive encephalopathy, QTc\>450 at baseline, other severe cardiovascular diseases including cerebrovascular accident (CVA)...
- Participant is considered a poor medical risk due to an uncontrolled medical disorder, non-malignant systemic disease, or active infection (including, r acute pelvic inflammatory disease), requiring intravenous...
- Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days...
- Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy...
- Participant with severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2; COVID-19) influenza A/B within 3 months of screening.
- Participant received a transfusion of blood products (including platelets or red blood cells) within 21 days prior to the first dose of the study drug.
- Participant has undergone major surgery in the 4 weeks prior to consent.
- Participant has -experienced any of the following with prior immunotherapy: any immune-related AE (irAE) of Grade 3 or higher, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia...
- Participant has taken part in a clinical trial of an investigational medical product or device within 30 days or 5 half-lives before study start, whichever comes later. [except hormonal IUD]
- Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for ≤5 years since end of treatment for the malignancy Non-melanoma skin cancer and...
- Participant has a known history of Human Immunodeficiency Virus (HIV), or a positive test at screening.
- Known active Hepatitis B or C, complete curative treatment and have no detectable viral RNA.
- Participants are known to be hypersensitive to the active substance or any of the excipients.
- Participant has a history or current diagnosis of interstitial lung disease.
- Participant has received or is scheduled to receive, a live vaccine within 30 days before the first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study...
- Unwilling or unable to follow protocol requirements, including attendance at follow-up visit/s.
- Participant has any condition contraindicated with tumor /blood sampling procedures required by the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.