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Clinical Trials List

Protocol NumberD798NC00001
NCT Number(ClinicalTrials.gov Identfier)NCT07000149
Not yet recruiting

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

    2026/02/01

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

Phase Ib Primary Objective: Evaluate the safety and tolerability of volrustomig combined with casdatifan in groups 1A and 1B, and confirm RP3D. Secondary Objectives: Evaluate the antitumor activity of volrustomig combined with casdatifan by assessing the objective response rate (ORR) in groups 1A and 1B. Evaluate the efficacy of volrustomig combined with casdatifan by assessing the duration of response (DoR) in groups 1A and 1B. Evaluate the efficacy of volrustomig combined with casdatifan by assessing the progression-free survival (PFS) in groups 1A and 1B. Evaluate the efficacy of volrustomig combined with casdatifan by assessing the disease control rate (DCR) at week 24 in groups 1A and 1B. Evaluate the efficacy of volrustomig combined with casdatifan by assessing the time to response (TTR) in groups 1A and 1B. Efficacy of volrustomig combined with casdatifan: Pharmacokinetic (PK) evaluation of volrustomig and casdatifan administered concurrently in groups 1A and 1B.

Test Drug

N/A
N/A

Active Ingredient

Volrustomig
casdatifan

Dosage Form

N/A
N/A

Dosage

MG

Endpoints

Safety and tolerability.

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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