Phase 3 study of perioperative dostarlimab in participants with untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer
- Conditions
- Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon CancerMedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2MedDRA version: 20.0Level: PTClassification code: 10001167Term: Adenocarcinoma of colon Class: 100000004864MedDRA version: 20.0Level: HLTClassification code: 10010023Term: Colorectal neoplasms malignant Class: 10029104MedDRA version: 20.0Level: HLGTClassification code: 10017991Term: Gastrointestinal neoplasms malignant and unspecified Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503265-27-00
- Lead Sponsor
- Glaxosmithkline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 710
Is at least 18 years of age., Has an ECOG- PS of 0 or 1., Has adequate organ function., Has untreated pathologically confirmed colon adenocarcinoma., Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III., Has radiologically evaluable disease., Has a tumor demonstrating the presence of either a dMMR status or MSI-H phenotype., Participants who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) or EPCAM gene may be eligible to participate., Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of colon cancer., Is willing to use adequate contraception., Can provide a signed informed consent.
Has distant metastatic disease., Is immunocompromised., Has documented presence of HBsAg at Screening or within 3 months prior to randomization., 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-mediated 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, TEN, or DRESS syndrome), or myocarditis of any grade., Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment., Has a history of congenital long QT syndrome., Has a history of or evidence of cardiac abnormalities., Is receiving any other anticancer or experimental therapy., Is receiving immunosuppressive medication., Has received systemic corticosteroids (>10 mg daily prednisone or equivalent) within 7 days of first dose of study intervention., Has received any live vaccine within 30 days of enrollment., Has a positive HCV antibody test result at Screening Visit or within 3 months prior to randomization., Has a positive HCV RNA test result at Screening Visit or within 3 months prior to randomisation., Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 9 months after the last dose of study intervention., Has any condition that would exclude the patient from chemotherapy with FOLFOX or CAPEOX., Has any history of interstitial lung disease or pneumonitis. Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice., Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate., Has a history of allogenic stem cell transplantantion or organ transplantation., Has received prior medical therapy, radiation therapy or surgery for management of colon cancer., Has a tumor that is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery., Has a tumor that is not amenable to surgery or has any other contraindication to surgery., Has a known additional malignancy that progressed or required active treatment within the past 2 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method