Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of IFx-Hu2.0 as an Adjunctive Therapy to Pembrolizumab in Checkpoint-Inhibitor Naïve Participants With Advanced or Metastatic Merkel Cell Carcinoma

Обзор

This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.

Вмешательства

• Препарат IFx-Hu2.0
  Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional
• Препарат Placebo
  Route of Administration: • Intralesional
• Препарат Pembrolizumab
  Therapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: 12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment]

Вторичные конечные точки (1)

• Progression free survival (PFS) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• At least 18 years of age.
• Life expectancy equal to or greater than six months.
• Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
• Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed Merkel cell carcinoma

• Must have at least one injectable lesion equal to or greater than 3 mm.
• Must have measurable disease as defined by RECIST v1.1.
• Participants should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
• Tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. If archival tissue is not available, then a new biopsy should be performed.
• Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.

Критерии исключения

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements.
• Participants with known active brain metastases with the exception of treated brain metastases that have imaging proving stability at least 4 weeks prior to the start of study treatment, no new metastases, and not requiring steroids.
• Participants with recurrent resectable MCC
• Participants with prior systemic chemotherapy
• Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
• Active, known, or suspected autoimmune disease. Potential Participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. Low-grade autoimmune toxicity is NOT an exclusion under this criterion.
• A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 18 центров

• USC Norris Comprehensive Cancer Center — Los Angeles
• University of California San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco
• Stanford Health Care - Skin Cancer Program — Stanford
• University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora
• Mayo Clinic Comprehensive Cancer Center — Jacksonville
• Sylvester Comprehensive Cancer Center — Miami
• Moffitt Cancer Center — Tampa
• Dana-Farber Cancer Institute — Boston
• … и ещё 10 центров

Идентификаторы

NCT: NCT06947928 · MCC 2021-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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