Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment

Официальное название

A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.

Обзор

The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal/rectal cancer that has spread to other parts of the body and will not respond to standard care.

Вмешательства

• Препарат Pembrolizumab
  Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Pembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.
• Препарат Lenvatinib
  Lenvatinib will be taken once daily, with or without food, at the same time each day.

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: End of treatment up to 2 years]

Вторичные конечные точки (4)

• Disease control rate (DCR) [Срок оценки: End of treatment up to 2 years]
• Progression free survival (PFS) [Срок оценки: 2 years after end of treatment]
• Overall survival (OS) [Срок оценки: 2 years after end of treatment]
• Treatment Percentage [Срок оценки: End of treatment up to 2 years]

Критерии участия

Критерии включения

• Histological confirmation of anorectal squamous cell carcinoma per the American Joint Committee on Cancer 8th edition. NOTE: If archived tissue is not available for diagnostic histological confirmation \[core, incisional, or excisional\], a new biopsy of a tumor lesion prior to tumor irradiation should be obtained.
• Unresectable locally advanced or metastatic anorectal squamous cell carcinoma following progression on first line chemotherapy or chemoradiation therapy. Prior use of immunotherapy with Retifanlimab is allowed but not mandatory.
• Prior chemoradiation therapy with either definitive intent or palliative intent is allowed.
• Measurable disease based on Response Evaluation Criteria In Solid Tumors 1.1 Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions within 28 days prior to registration.

Критерии исключения

• Has received prior therapy with an anti-PD-1, anti- PDL1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) with the exception of Retifanlimab immunotherapy.
• Prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agents including events like pneumonitis, myocarditis, renal failure, Guillain Barre syndrome or myasthenia gravis.
• Active autoimmune disease with ongoing treatment with chronic immunosuppressive therapy such as DMARDs .

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

США · 1 центр

• University of Chicago Medicine Comprehensive Cancer Center — Chicago

Идентификаторы

NCT: NCT06669572 · IRB24-1542

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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