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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

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

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Not Recruiting

Mar. 31, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-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

Both

Rectal cancer

Dostarlimab
Dostarlimab will be administered.

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

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

+81-3-3542-2511

Mar. 01, 2023

No

United Kingdom