A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)

Официальное название

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC)

Обзор

The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)

Вмешательства

• Препарат Pumitamig
  Specified dose on specified days
• Препарат Ipilimumab
  Specified dose on specified days
• Препарат Cabozantinib
  Specified dose on specified days

Первичные конечные точки

• Number of participants with adverse events (AEs) [Срок оценки: Up to approximately 2 years from end of treatment]
• Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) [Срок оценки: Up to approximately 2 years from end of treatment]
• Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [Срок оценки: Up to day 21 from first dose]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to approximately 2 years from end of treatment]
• Number of participants with AEs leading to death [Срок оценки: Up to approximately 2 years from end of treatment]
• Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment [Срок оценки: Up to approximately 2 years from end of treatment]

Вторичные конечные точки (7)

• Number of participants with AEs [Срок оценки: Up to approximately 2 years from end of treatment]
• Number of participants with SAEs (as per CTCAE v5) [Срок оценки: Up to approximately 2 years from end of treatment]
• Number of participants with treatment-related adverse events (TRAEs) [Срок оценки: Up to approximately 2 years from end of treatment]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to approximately 2 years from end of treatment]
• Number of participants with AEs leading to death [Срок оценки: Up to approximately 2 years from end of treatment]
• Progression-free survival (PFS) by RECIST v1.1 per investigator assessment [Срок оценки: Up to 4 years from randomization]
• Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment [Срок оценки: Up to approximately 2 years from end of treatment]

Критерии участия

Критерии включения

• Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC).
• Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants with ccRCC.
• Participants may have favorable, intermediate or poor risk disease categories.
• Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions:

i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.

ii) For Part 1A participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received any therapy targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) (e.g., ipilimumab).

iii) For Part 1B participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib.

\- Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Критерии исключения

• Participants must not have any untreated known CNS metastases.
• Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1).
• Participants must not have a history of interstitial lung disease or pneumonitis.
• Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures.
• Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to C1D1, uncontrolled hypertension (≥ 150 systolic, ≥ 90 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
• Participants must not have a urine protein ≥ 2+ and 24 hour urine protein ≥ 1 g at baseline.
• Participants must not have evidence of major coagulation disorders.
• Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 6 months prior to C1D1.
• Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months.
• Participants must not have had a major surgery or trauma within 28 days prior to C1D1.
• Other protocol-defined Inclusion/Exclusion criteria apply.

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

Открытое

Основная цель

Лечение

Центры проведения

США · 18 центров

• Local Institution - 0178 — Palo Alto
• Local Institution - 0117 — New Haven
• Sibley Memorial Hospital — Washington D.C.
• Local Institution - 0177 — Miami
• Local Institution - 0126 — Orlando
• Local Institution - 0175 — Atlanta
• Local Institution - 0170 — Fort Wayne
• Local Institution - 0124 — Iowa City
• … и ещё 10 центров

Великобритания · 8 центров

Список центров уточняется — проверьте первичный протокол.

Китай · 7 центров

• Local Institution - 0143 — Пекин
• Local Institution - 0157 — Пекин
• Local Institution - 0182 — Гуанчжоу
• Local Institution - 0183 — Changsha Shi
• Local Institution - 0184 — Нанкин
• Local Institution - 0188 — Shanghai Shi
• Local Institution - 0144 — Пекин

Япония · 6 центров

• Local Institution - 0180 — Kobe
• Local Institution - 0179 — Shiwa-gun Yahaba-cho
• The Cancer Institute Hospital of JFCR — Koto-ku
• Local Institution - 0078 — Toyoma
• Kyushu University Hospital — Fukuoka
• Local Institution - 0181 — Niigata

Мексика · 6 центров

• Local Institution - 0046 — Monterrey
• Local Institution - 0048 — Oaxaca City
• Local Institution - 0122 — Puebla City
• Local Institution - 0049 — Tlalpan
• Local Institution - 0108 — Tlalpan
• Local Institution - 0118 — Tlalpan

Австралия · 5 центров

• Macquarie University — North Ryde
• GenesisCare St Leonards — St Leonards
• Local Institution - 0011 — Herston
• Local Institution - 0074 — South Brisbane
• Local Institution - 0003 — Malvern

Германия · 4 центра

• Local Institution - 0025 — Jena
• Local Institution - 0026 — Hamburg
• Local Institution - 0014 — Herne
• Local Institution - 0027 — München

Румыния · 4 центра

• Local Institution - 0103 — Cluj-Napoca
• Local Institution - 0161 — Craiova
• Local Institution - 0100 — Iași
• Local Institution - 0101 — Sibiu

Канада · 3 центра

• Local Institution - 0007 — Calgary
• Local Institution - 0109 — Montreal
• Local Institution - 0009 — Montreal

Чили · 3 центра

• Local Institution - 0105 — Santiago
• Bradfordhill — Santiago
• Local Institution - 0163 — Santiago

Чехия · 3 центра

• Local Institution - 0147 — Prague
• Local Institution - 0149 — Brno
• Local Institution - 0150 — Hradec Králové

Финляндия · 3 центра

• Local Institution - 0044 — Helsinki
• Local Institution - 0029 — Turku
• Local Institution - 0060 — Vantaa

Франция · 3 центра

• Local Institution - 0083 — Lille
• Local Institution - 0080 — Boredeaux
• Local Institution - 0028 — Villejuif

Италия · 3 центра

• Local Institution - 0139 — Verona
• Local Institution - 0073 — Milan
• Local Institution - 0087 — Napoli Campania

South Korea · 3 центра

• Local Institution - 0112 — Seoul
• Local Institution - 0017 — Seoul
• Local Institution - 0167 — Seoul

Испания · 3 центра

• Local Institution - 0013 — Madrid
• Local Institution - 0091 — Madrid
• Local Institution - 0043 — Seville

Швейцария · 3 центра

Список центров уточняется — проверьте первичный протокол.

Аргентина · 2 центра

• Instituto Medico Especializado Alexander Fleming — Buenos Aires
• Local Institution - 0156 — Buenos Aires

Ирландия · 2 центра

• Local Institution - 0059 — Dublin
• Local Institution - 0062 — Dublin

Бразилия · 1 центр

• Hospital Sirio Libanes — Brasília

Колумбия · 1 центр

• Local Institution - 0052 — Cali

Идентификаторы

NCT: NCT07293351 · CA266-0008 · 2025-523637-26 · U1111-1327-6332

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗