Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
ID06278857

A Phase 2b, Open-label, Single Arm Study of Dostarlimab in Women With Early-stage MMR Deficient Endometrioid Endometrial Adenocarcinoma

Led by Queensland Centre for Gynaecological Cancer · Updated on 2024-12-03

10

Participants Needed

3

Research Sites

104 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

Researchers are evaluating dostarlimab, an immunotherapy drug, as a potential alternative to surgery for women with early-stage endometrial cancer that has Mismatch Repair deficiency, a genetic cause found in 20-30% of cases. This Phase 2b study aims to determine the effectiveness and safety of dostarlimab in treating this specific type of cancer, especially for women who cannot or prefer not to have surgery, including those wishing to preserve fertility or those with other health concerns. Participants will receive seven sessions of dostarlimab over 12 months. The treatment schedule includes four cycles every three weeks, followed by a three-week break, then three cycles every six weeks. This single-arm, open-label study will test this regimen's ability to eliminate endometrial cancer without surgery, exploring a less invasive treatment option. During the study, participants will undergo clinical evaluations, imaging scans, laboratory tests, and monitoring for immune-related adverse events. Researchers will assess cancer absence at six months, safety and tolerability throughout treatment and follow-up at 9 and 12 months, and longer-term changes in clinical and laboratory parameters. The study also includes participant feedback and explores fertility outcomes. Total participation lasts about one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participant at least 18 years old at the time of consent
  • Histologically or cytologically proven Stage 1, FIGO grade 1 or 2, MMR deficient endometrioid endometrial adenocarcinoma
  • Participant wishes to preserve the uterus or is not suitable for hysterectomy
  • ECOG performance status of 2 or less
  • No evidence of extrauterine disease based on clinical exam and imaging
  • Adequate organ and bone marrow function as defined in protocol
  • Women of child-bearing potential must have negative pregnancy test and use effective contraception or be abstinent
  • Post-menopausal females confirmed by hormone testing
  • Well-controlled Type I or II diabetes with HbA1c less than 8.5%
  • Normal or controlled blood pressure
  • Able to provide informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Histological type other than endometrioid adenocarcinoma (e.g., sarcomas, high-risk types)
  • Pregnant, breastfeeding, or planning pregnancy during trial
  • History of allogeneic tissue or organ transplant
  • Uncontrolled hypertension or severe cardiovascular diseases within past 6 months
  • Poor medical risk due to uncontrolled medical disorders or active infections
  • Immunodeficiency or recent immunosuppressive therapy
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Recent COVID-19 or influenza infection within 3 months
  • Recent blood transfusions within 21 days before first dose
  • Major surgery within 4 weeks prior to consent
  • Prior severe immune-related adverse events from immunotherapy
  • Participation in another investigational trial within 30 days or 5 half-lives
  • Concomitant malignancies or prior non-endometrial invasive malignancy less than 5 years disease-free
  • Known HIV or active Hepatitis B or C infection
  • Hypersensitivity to dostarlimab or its components
  • History or current diagnosis of interstitial lung disease
  • Recent live vaccine within 30 days before first dose and up to 180 days after last dose
  • Unwilling or unable to follow protocol requirements
  • Conditions contraindicating tumor or blood sampling procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive seven dostarlimab treatment sessions over 12 months according to the study protocol.

7 treatment sessions: 4 cycles every 3 weeks, followed by a 3-week break, then 3 cycles every 6 weeks

Follow-up

Duration - Up to 12 months post-treatment

Participants are monitored for safety, tolerability, and clinical outcomes up to 12 months after treatment.

Visits at 9 and 12 months post-treatment for assessments

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

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Research Team

S

Sara Baniahmadi

V

Vanessa Behan

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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Frequently Asked Questions

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Published Research Related To This Trial

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.

Andreas Obermair, Val Gebski, Jeffrey Goh...

https://pubmed.ncbi.nlm.nih.gov/39955187