A Phase 2 Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1)
- Conditions
- Rectal cancer
- Registration Number
- JPRN-jRCT2031220656
- Lead Sponsor
- Ishibashi Hideyasu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
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
-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
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.
- Secondary Outcome Measures
Name Time Method The efficacy, safety, immunogenicity and PK of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.