A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China

Last updated: March 14, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Colon Cancer

Rectal Cancer

Treatment

Dostarlimab

Clinical Study ID

NCT06640049
221972
  • Ages > 18
  • All Genders

Study Summary

The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment.

Eligibility Criteria

Inclusion

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 centralassessment

Exclusion

Exclusion Criteria:

  • Participant has distant metastatic disease

  • Participant has received prior radiation therapy, systemic therapy, or surgery formanagement of rectal cancer

  • Has a known additional malignancy that progressed or required active treatmentwithin the past 2 years

  • Has an active autoimmune disease that has required systemic treatment in the past 2years

  • Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3,immune-related severe neurologic events of any-grade (e.g., myasthenicsyndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transversemyelitis), exfoliative dermatitis of any grade [SJS (Stevens-Johnson Syndrome, TEN (Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemicsymptoms)], or myocarditis of any grade. Non-clinically significant laboratoryabnormalities 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 donorstem 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 itsexcipients

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: Dostarlimab
Phase: 2
Study Start date:
October 17, 2024
Estimated Completion Date:
April 15, 2031

Connect with a study center

  • GSK Investigational Site

    Changsha, 410013
    China

    Site Not Available

  • GSK Investigational Site

    Chengdu, 610041
    China

    Active - Recruiting

  • GSK Investigational Site

    Chongqing, 400010
    China

    Active - Recruiting

  • GSK Investigational Site

    Guangzhou, 510060
    China

    Active - Recruiting

  • GSK Investigational Site

    Hangzhou,
    China

    Active - Recruiting

  • GSK Investigational Site

    Harbin, 150000
    China

    Site Not Available

  • GSK Investigational Site

    Jinan, 250117
    China

    Active - Recruiting

  • GSK Investigational Site

    Kunming, 650106
    China

    Site Not Available

  • GSK Investigational Site

    Shanghai, 200032
    China

    Active - Recruiting

  • GSK Investigational Site

    Taiyuan, 030013
    China

    Active - Recruiting

  • GSK Investigational Site

    Zhengzhou, 450052
    China

    Site Not Available

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