A Phase 2 Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1)

Active, not recruiting

• Conditions: Rectal cancer

• Registration Number: jRCT2031220656
• Lead Sponsor: GlaxoSmithKline K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-23
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

-Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer -Participant has radiologically and endoscopically evaluable disease. -Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment

Exclusion Criteria

-Participant has distant metastatic disease. -Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer. -Participant has any history of interstitial lung disease or pneumonitis -Participant has experienced any of the following with prior immunotherapy: any irAE of Grade >-3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barre Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary. -Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers. -Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with 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) is not considered a form of systemic treatment. -Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
efficacy of dostarlimab		The efficacy of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.

Secondary Outcome Measures

Name	Time	Method
efficacy		The efficacy of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.
safety		The safety of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.
immunogenicity		The immunogenicity of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.
PK		The pharmacokinetics (PK) of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.