A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China (China AZUR-1)

GlaxoSmithKline (GSK)

Status and phase

Active, not recruiting

Phase 2

Conditions

Neoplasms, Rectal

Treatments

Biological: Dostarlimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06640049

221972

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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