SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)

NCT06278857 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: QCGC-001/2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

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

Endometrial Cancer Stage I; Mmr Deficiency; Endometrioid Endometrial Adenocarcinoma; Immune-related Adverse Event

Keywords

Endometrial Cancer Stage I; Mmr Deficiency; Immunotherapy drug; Anti-programmed death receptor - 1(PD-1)

Outcome Measures

Primary Outcomes (1)

• Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab.

  Number of participants achieving investigator-assessed pathological complete response (pCR).

  Week 27 (Month 6)

Secondary Outcomes (10)

• Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma.

  From Cycle 1 /Day 1 to 30 days post last dose, 9 and 12months.

• TEAEs/irAEIs Leading to Study Drug Discontinuation

  Screening to Cycle 7 (Week 25)

• TEAEs/irAEIs Leading to Study Withdrawal

  From Screening to Week 27 (6 months) 9 and 12months.

• Clinically Significant Changes in Haematology

  From Screening to Week 27 (6 months) 9 and 12months to End of Study.

• Clinically Significant Changes in Clinical Chemistry

  From Screening to Week 27 (6 months) 9 and 12months to End of Study.

Other Outcomes (14)

• Study Feasibility Outcome: Recruitment Rate

  2 Years

• Study Feasibility Outcome: Rationale for Treatment Discontinuation

  through study completion, an average of 2 year

• Study Feasibility Outcome: Study Withdrawal Rate

  through study completion, an average of 2 year

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Drug: Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]

Interventions

Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI] DRUG

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.

Also known as: JEMPERLI

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, PMS2, MSH2, MSH6) by immunohistochemistry.) endometrioid endometrial adenocarcinoma, and
• ii. wish to preserve the uterus or are not a suitable candidate for hysterectomy.
• 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, or X-ray and screening gadolinium contrast pelvic MRI
• 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
• 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.

You may not qualify if:

• 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), 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.
• 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).
• 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.
• 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.
• 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 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 definitively treated in-situ carcinomas is allowed.
• 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.

Sponsors & Collaborators

• Queensland Centre for Gynaecological Cancer: lead
• GlaxoSmithKline: collaborator

Study Sites (3)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

NOT YET RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Related Publications (1)

• Obermair A, Gebski V, Goh J, Kuchel A, Brand A, Mak B, McNally O, Baxter E, Jobling T, Mileshkin L. Phase 2b, open-label, single-arm, multicenter pilot study of the efficacy, safety, and tolerability of dostarlimab in women with early-stage mismatch repair-deficient endometrioid endometrial adenocarcinoma. Int J Gynecol Cancer. 2025 Apr;35(4):101644. doi: 10.1016/j.ijgc.2025.101644. Epub 2025 Jan 16.

  PMID: 39955187 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Turcot syndrome

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Andreas Obermair, Professor

  Queensland Centre for Gynaecological Cancer (QCGC) Research

  STUDY CHAIR

Central Study Contacts

Sara Baniahmadi

CONTACT

07 3346 5073; s.baniahmadi@uq.edu.au

Vanessa Behan

CONTACT

07 3346 5590; v.behan@uq.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a non-randomised, prospective, pilot, open-label, single arm study. Participation in this trial 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.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 26, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)