Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 imAE of 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 (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.
Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).
Clareo Health | A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
