Evaluating dostarlimab for untreated locally advanced rectal cancer in China
A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer in China
PHASE2 · GlaxoSmithKline · NCT06640049
This study is testing if a new treatment called dostarlimab can help Chinese patients with untreated locally advanced rectal cancer that has specific genetic features.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GlaxoSmithKline (industry) |
| Drugs / interventions | dostarlimab, immunotherapy, radiation |
| Locations | 8 sites (Chengdu and 7 other locations) |
| Trial ID | NCT06640049 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of dostarlimab, a monoclonal antibody, in treating Chinese participants with untreated locally advanced rectal cancer characterized by mismatch-repair deficiency (dMMR) or microsatellite instability-high (MSI-H). Participants must have histologically confirmed Stage II to III rectal adenocarcinoma and evaluable disease through radiological and endoscopic methods. The study focuses on individuals who have not received prior treatments for their cancer. By targeting specific tumor characteristics, the study seeks to provide insights into the potential of immunotherapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults with untreated, locally advanced rectal adenocarcinoma that is dMMR or MSI-H.
Not a fit: Patients with distant metastatic disease or those who have received prior treatments for rectal cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with locally advanced rectal cancer, potentially improving outcomes and survival rates.
How similar studies have performed: Other studies have shown promise with immunotherapy approaches in similar cancer types, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal adenocarcinoma * Participant has radiologically and endoscopically evaluable disease * Participant has a tumor which can be categorized as dMMR or MSI-H by central assessment Exclusion Criteria: * Participant has distant metastatic disease * Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer * Has a known additional malignancy that progressed or required active treatment within the past 2 years * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3, 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 \[SJS (Stevens-Johnson Syndrome, TEN (Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemic symptoms)\], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary * Has any history of interstitial lung disease or pneumonitis * Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant) * Has a history of severe allergic and/or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients
Where this trial is running
Chengdu and 7 other locations
- GSK Investigational Site — Chengdu, China (RECRUITING)
- GSK Investigational Site — Chongqing, China (RECRUITING)
- GSK Investigational Site — Guangzhou, China (RECRUITING)
- GSK Investigational Site — Guangzhou, China (RECRUITING)
- GSK Investigational Site — Hangzhou, China (RECRUITING)
- GSK Investigational Site — Jinan, China (RECRUITING)
- GSK Investigational Site — Shanghai, China (RECRUITING)
- GSK Investigational Site — Taiyuan, China (RECRUITING)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neoplasms, Rectal, Dostarlimab, GSK4057190A, TSR-042, Rectal cancer, dMMR, MSI-H