CD70-Targeted Immuno-PET/CT-Directed Free of Therapy Used for mccRCC Patients With IMDC Favorable or Intermediate Risk

Recruiting now · Phase 2

Conditions studied: Metastatic Clear Cell Renal Cell Carcinoma

In brief

The purpose of this study is to evaluate the safety and feasibility of a treatment holiday strategy directed by CD70-targeted immuno-PET/CT in patients with metastatic clear cell renal cell carcinoma (mccRCC). Specifically, the study aims to assess whether patients who achieve both anatomical disease control and metabolic response after 12 months of first-line PD-1/PD-L1 ICI + VEGFR-TKI combination therapy can safely pause their treatment, improve quality of life without compromising therapeutic efficacy.

Key facts

Study ID

NCT07615348

Run by

Jinling Hospital, China

People needed

75

Starts

2026-06-16

Expected to finish

2029-08-10

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• STEP0: At Treatment Initiation
• Male or female subjects aged ≥ 18 years
• Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV)
• Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype
• Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
• Karnofsky Performance Status (KPS) grade ≥ 70%
• At least one measurable lesion on CT per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• At least one high-uptake target lesion on CD70-targeted immuno-PET/CT per Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) version 1.0
• If CD70-negative lesions (visible on CT but lacking CD70 avidity on PET/CT) are present at baseline, they must meet ALL the following conditions: cannot be target lesions, cannot be located in major involved organs, must be ≤ 3 in number, and must account for ≤ 30% of the total tumor burden
• Adequate organ and bone marrow function meeting all laboratory criteria:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count ≥ 100 × 10\^9/L; Hemoglobin ≥90 g/L
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × upper limit of normal(ULN) (or ≤ 5 × ULN if hepatic metastases are present). Total bilirubin ≤ 1.5 × ULN (≤ 3 mg/dL if Gilbert's syndrome)
• Serum creatinine ≤ 2.0 × ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the Cockcroft-Gault formula
• Capacity to comprehend and comply with protocol requirements, with documented informed consent signed
• Contraception agreement for sexually active fertile participants and partners to use medically accepted methods during the study and continue for 5 months after last treatment
• Negative pregnancy status at screening for women of childbearing potential
• STEP1: At 12-Month Evaluation
• Patient met all eligibility criteria outlined above
• Patient must receive 12 months (±1m) of first line PD-1/PD-L1 ICI + VEGFR-TKI therapy, without permanent discontinuation of both agents due to unmanageable toxicity
• Patient must have completed an CD70-targeted immuno-PET/CT scan at 12m (±1m) from start of initial therapy
• Patients must meet one of the following criteria:
• Eligible for treatment discontinuation: For CD70-Positive Lesions: Sustained Disease Control (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]) on CT for ≥ 12 weeks per RECIST 1.1, AND achieved Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) on CD70 immuno-PET/CT per PERCIST 1.0 criteria; For CD70-Negative Lesions (If present at baseline): Must achieve a deep anatomical response, defined as Complete Response (CR) or Partial Response (PR) on CT, maintained for ≥ 12 weeks per RECIST 1.1
• Treatment continuation: not meeting criteria above

You may not qualify if…

• STEP0: At Treatment Initiation
• Prior systemic therapy for advanced RCC
• Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
• Karnofsky Performance Status (KPS) <70%
• Inadequate organ and bone marrow function
• Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) who are clinically stable without progression prior to treatment
• Concurrent or prior invasive malignancies within the past 5 years, except adequately treated in situ/superficial cancers (e.g., non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix/breast)
• Presence of uncontrolled major comorbidities or recent severe illnesses within 6 months, including but not limited to: uncontrolled hypertension, clinically significant cardiovascular disease, GI disorders with high risk of perforation/fistula, significant hematuria, hematemesis, hemoptysis, major bleeding history, severe active infections (including active HIV, HBV, or HCV), or severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis)
• Life expectancy < 6 months
• Known allergy or hypersensitivity to the CD70 imaging agent or any of its excipients
• Severe hepatic or renal insufficiency, or inability to tolerate PET/CT examination
• Medical/psychiatric/social conditions compromising protocol compliance
• Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment
• STEP1: At 12-Month Evaluation
• Failure to complete 12 months(±1m) of first-line PD-1/PD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or disease progression
• Failure or inability to undergo CD70-targeted immuno-PET/CT scan at the 12-month evaluation timepoint
• Unacceptable clinical deterioration or investigator discretion indicating that a treatment holiday is not in the best interest of the patient

Where it is running

• Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing, Jiangsu, China (enrolling)
• Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• Sir Run Run Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• Wuxi No.2 People's Hospital (Jiangnan University Medical Center) — Wuxi, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.