A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China

Launched by GLAXOSMITHKLINE · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dostarlimab in people with a specific type of rectal cancer that has not been treated before. The trial focuses on patients in China who have locally advanced rectal cancer that has certain genetic features, making it easier for the medication to target the cancer. The main goal is to see how well dostarlimab works in shrinking or stopping the growth of the cancer.

To be eligible for this trial, participants must have been diagnosed with Stage II to III rectal cancer and their tumors must show specific characteristics that can be confirmed by medical tests. They should not have received any prior treatments like surgery or radiation for their cancer. Participants can expect to receive dostarlimab as their only treatment and will be closely monitored throughout the study. It's important to note that individuals with certain health conditions or previous severe reactions to similar treatments may not be eligible to join the trial.

Gender

ALL

Eligibility criteria

• 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