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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06278857




Registration number
NCT06278857
Ethics application status
Date submitted
18/01/2024
Date registered
26/02/2024

Titles & IDs
Public title
SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)
Scientific title
A Phase 2b, Open-label, Single Arm, Multicentre, Pilot Study of the Efficacy, Safety and Tolerability of Dostarlimab in Women With Early-stage MMR Deficient Endometrioid Endometrial Adenocarcinoma.
Secondary ID [1] 0 0
QCGC-001/2023
Universal Trial Number (UTN)
Trial acronym
SATELLITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer Stage I 0 0
Mmr Deficiency 0 0
Endometrioid Endometrial Adenocarcinoma 0 0
Immune-related Adverse Event 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]

Experimental: Single Arm - Participation involves seven dostarlimab sessions over 12 months, with a treatment protocol of four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.


Treatment: Drugs: Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]
The dosing regimen follows standard clinical care protocol comprising of 4 cycles every 3-weeks, a rest period of 34 weeks followed by 3 cycles every 6 weekly for a total of 7 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab.
Timepoint [1] 0 0
Week 27 (Month 6)
Secondary outcome [1] 0 0
Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma.
Timepoint [1] 0 0
From Cycle 1 /Day 1 to 30 days post last dose, 9 and 12months.
Secondary outcome [2] 0 0
TEAEs/irAEIs Leading to Study Drug Discontinuation
Timepoint [2] 0 0
Screening to Cycle 7 (Week 25)
Secondary outcome [3] 0 0
TEAEs/irAEIs Leading to Study Withdrawal
Timepoint [3] 0 0
From Screening to Week 27 (6 months) 9 and 12months.
Secondary outcome [4] 0 0
Clinically Significant Changes in Haematology
Timepoint [4] 0 0
From Screening to Week 27 (6 months) 9 and 12months to End of Study.
Secondary outcome [5] 0 0
Clinically Significant Changes in Clinical Chemistry
Timepoint [5] 0 0
From Screening to Week 27 (6 months) 9 and 12months to End of Study.
Secondary outcome [6] 0 0
Clinically Significant Changes in Thyroid Function
Timepoint [6] 0 0
From Screening to Week 27 (6 months)
Secondary outcome [7] 0 0
Abnormal Vital Signs
Timepoint [7] 0 0
From Screening to Week 27 (6 months) 9 and 12months.
Secondary outcome [8] 0 0
Abnormal Electrocardiogram (ECG) Parameters
Timepoint [8] 0 0
Screening, Week 12 (3 months) and Week 27 (6 months)
Secondary outcome [9] 0 0
Clinically Significant Abnormal Physical Examination
Timepoint [9] 0 0
From screening visit to Week 27 (6 months), 9 and 12 months
Secondary outcome [10] 0 0
Concomitant Medications
Timepoint [10] 0 0
From Screening to 12 months.

Eligibility
Key inclusion criteria
1. Female participant is at least 18 years of age (at the time of informed consent).
2. 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 adenocarcinoma, and

ii. wish to preserve the uterus or are not a suitable candidate for hysterectomy.
3. Participant has an ECOG performance status of = 2
4. 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, or X-ray and screening gadolinium contrast pelvic MRI
5. 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 < 1.5x institutional upper limit normal (ULN) v. AST/ALT < 2. 5 - 3x ULN

Adequate renal function as defined by:

vi. Creatinine < 1.5x institutional upper limits OR creatinine clearance > 30 ml/min

Adequate coagulation profile:

vii. INR or PT = 1.5 x ULN unless the participant is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulants viii. aPTT = 1.5 x ULN unless the patient is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulant
6. 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 included only if the Investigator considers that the finding is unlikely to introduce additional risk factors to the participant and will not interfere with the study procedures.
7. 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], or an intrauterine hormone device [IUD]) from screening until at least 4 months following the last dose of dostarlimab. Females who are abstinent from heterosexual intercourse as part of their usual lifestyle do not need to use contraception.
8. 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.
9. 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 at home during study participation.
10. Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension.
11. Participant is able to provide written informed consent and are willing to participate for the duration of the study and to follow study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant has a histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high-risk endometrial e.g., papillary serous, clear cell).
2. Participant is pregnant, breastfeeding, or planning to become pregnant during the trial period.
3. Participant has had an allogeneic tissue/solid organ transplant.
4. Participants with uncontrolled hypertension, history of hypertension crisis, history of hypertensive encephalopathy, QTc>450 at baseline, other severe cardiovascular diseases including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, New York Heart Association (NYHA) class III and IV heart failure and uncontrolled arrhythmia within the past 6 months. Rate-controlled arrhythmia may be eligible at the discretion of the Investigator.
5. 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 antibiotics within the past 2 weeks. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
6. 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 before the study start.
7. 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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed.
8. Participant with severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2; COVID-19) influenza A/B within 3 months of screening.
9. 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.
10. Participant has undergone major surgery in the 4 weeks prior to consent.
11. 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 gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.)
12. 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]
13. 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 definitively treated in-situ carcinomas is allowed.
14. Participant has a known history of Human Immunodeficiency Virus (HIV), or a positive test at screening.
15. Known active Hepatitis B or C, complete curative treatment and have no detectable viral RNA.
16. Participants are known to be hypersensitive to the active substance or any of the excipients.
17. Participant has a history or current diagnosis of interstitial lung disease.
18. 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 treatment.
19. Unwilling or unable to follow protocol requirements, including attendance at follow-up visit/s.
20. Participant has any condition contraindicated with tumor /blood sampling procedures required by the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GlaxoSmithKline Research & Development Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair, Professor
Address 0 0
Queensland Centre for Gynaecological Cancer (QCGC) Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sara Baniahmadi
Address 0 0
Country 0 0
Phone 0 0
07 3346 5073
Fax 0 0
Email 0 0
s.baniahmadi@uq.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06278857