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Clinical Trials List

Protocol NumberD798NC00001
NCT Number(ClinicalTrials.gov Identfier)NCT07000149
Completed

2025-09-10 - 2028-06-13

Phase I

Recruiting4

A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/18

Investigators and Locations

Principal Investigator Jian-Ri Li 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Ping Huang Division of Urology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Clear Cell Renal Cell Carcinoma

Objectives

第 Ib 期 主要目標: 評估第 1A 組和第 1B 組中 volrustomig 併用 casdatifan 的安全性和耐受性，並確認 RP3D 次要目標: 透過評估第 1A 組和第 1B 組的客觀反應率 (ORR)，評估 volrustomig 併用 casdatifan 的抗腫瘤活性 透過評估第 1A 組和第 1B 組的反應持續時間 (DoR)，評估 volrustomig 併用 casdatifan 的療效 透過評估第 1A 組和第 1B 組的 PFS，評估 volrustomig 併用casdatifan 的療效 透過評估第 1A 組和第 1B 組第 24 週時疾病控制率 (DCR)，評估 volrustomig 併用 casdatifan 的療效 透過評估第 1A 組和第 1B 組的反應發生時間 (TTR)，評估 volrustomig 併用 casdatifan 的療效 評估第 1A 組和第 1B 組同時給予 volrustomig 和 casdatifan 的藥物動力學 (PK)

Test Drug

凍晶注射劑
膜衣錠

Active Ingredient

Volrustomig
casdatifan

Dosage Form

243
116

Dosage

MG

Endpoints

安全性和耐受性。

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically confirmed RCC with clear cell component.
Advanced/metastatic RCC or recurrent disease that has not previously been treated with systemic therapy in the 1L setting.
Karnofsky Performance Status ≥ 70%.
Provision of acceptable tumor sample.
At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.

Exclusion Criteria

Exclusion Criteria:

History of leptomeningeal disease or spinal cord compression.
Symptomatic brain metastases.
Medical history of severe chronic obstructive pulmonary disease.
Active or prior documented autoimmune or inflammatory disorders.
Prior systemic therapy for advanced/metastatic RCC. Note - Other inclusion and exclusion criteria may apply as stated in the protocol.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    60 participants

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