A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer

Официальное название

A Phase 3b, Open-label Study Investigating the Duration of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer

Обзор

This study is conducted in adults with rectal cancer that has a certain genetic type. The main goal is to find out whether a longer treatment period with dostarlimab can help more participants have a complete response to treatment and avoid standard treatments like chemotherapy, radiation treatment, or surgery. Scans and endoscopy tests will be conducted to see if the tumor disappears and how long the cancer stays under control. The study will also collect information on side effects and health outcomes after dostarlimab.

Вмешательства

• Биопрепарат Dostarlimab
  Dostarlimab will be administered.

Первичные конечные точки

• Percentage of participants who achieve clinical complete response (cCR) amongst participants who receive > 9 cycles (> 6 months) of dostarlimab monotherapy by investigator assessment [Срок оценки: Up to 168 weeks]

Вторичные конечные точки (6)

• Overall cCR rate by investigator assessment [Срок оценки: Up to 171 weeks]
• Number of participants with sustained clinical complete response at 12 months (cCR12) as assessed by investigator [Срок оценки: Up to 171 weeks]
• Objective response rate (ORR) as assessed by investigator [Срок оценки: Up to 171 weeks]
• Number of participants with composite cCR12 and pathologic complete response (pCR) as assessed by investigator [Срок оценки: Up to 171 weeks]
• Time to cCR [Срок оценки: Up to 171 weeks]
• Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), immune-mediated adverse event (imAEs), and AEs leading to death or discontinuation of study intervention by severity [Срок оценки: Up to 171 weeks]

Критерии участия

Критерии включения

• Has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+) locally advanced rectal adenocarcinoma.
• Has radiologically and endoscopically evaluable disease.
• Has a tumor demonstrating the presence of either:

• dMMR status; MMR status must be assessed by immunohistochemistry for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of 1 or more proteins indicates dMMR; MMR status will be determined locally; or
• MSI-H phenotype as determined by polymerase chain reaction or by tissue next generation sequencing; MSI-H will be determined locally.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has adequate organ function.

Критерии исключения

• Has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer.
• Has a tumor that, in the investigator's judgment, is causing symptomatic bowel obstruction or otherwise requires urgent/emergent local intervention. Participants with a history of bowel obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning colostomy). Patients with a history of bowel obstruction in the context of current rectal cancer diagnosis and treated with stenting are not eligible.
• 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.
• Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment.
• Is receiving any other anticancer or experimental therapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07740720 · 308360 · 2026-526683-21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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