ClinicalTrials.gg
RecruitingNCT07615348PERFUMER-70Updated Aug 11, 2026

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

A Phase 2 interventional study of PD-1/PD-L1 ICI + VEGFR-TKI and Treatment pause in Metastatic Clear Cell Renal Cell Carcinoma, sponsored by Jinling Hospital, China. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Jinling Hospital, China · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Current first-line therapy for advanced renal cell carcinoma (RCC) combines tyrosine kinase inhibitors (TKIs) with immune checkpoint inhibitors (ICIs). Although effective, continuous treatment often results in cumulative toxicities, significant financial burdens, and potential overtreatment for patients.

While intermittent therapy shows promise in maintaining efficacy while mitigating adverse events, conventional CT relies on morphological changes and lacks the sensitivity to distinguish viable tumor tissue from post-treatment fibrosis or necrosis, hindering precise decision-making for treatment cessation. CD70 is a transmembrane protein highly expressed in over 80% of mccRCCs. CD70-targeted immuno-PET/CT, utilizing specific single-domain antibodies, provides a superior molecular imaging tool outperforming FDG-PET and allows for accurate assessment of treatment response to guide intermittent therapy.

In this multi-center, single-arm, phase II trial, mccRCC patients with IMDC favorable or intermediate risk will be enrolled to receive standard first-line ICI plus TKI combination therapy for 12 months (± 1 months) in the absence of disease progression or unacceptable toxicity. After that, patients will be evaluated using both CT (RECIST 1.1) and CD70 immuno-PET/CT (PERCIST criteria). Patients achieving sustained disease control on CT combined with Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) on CD70 immuno-PET/CT will qualify to pause all systemic treatments and enter treatment holiday. A per-lesion evaluation principle will be applied for baseline heterogeneous lesions. Patients fail to achieve the predefined criteria will continue first-line systemic therapy until disease progression or unacceptable toxicity.

During the treatment holiday, patients will undergo anatomical and molecular monitoring including CT scans every 8-12 weeks and CD70 immuno-PET/CT every 24 weeks. Circulating KIM-1 levels will be longitudinally assessed as an early-warning biomarker. A confirmed clinically meaningful elevation (e.g., ≥ 30% from nadir) may trigger unscheduled or more frequent radiographic evaluations. Original regimen will be immediately restarted upon the occurrence of anatomical progression (RECIST 1.1), metabolic flare (PERCIST), or clinical symptom deterioration.

Peripheral blood, other biological samples, and health-related quality of life questionnaires will be collected at different time points during the trial for future analyses.This study aims to establish a multidimensional decision-making framework to optimize the balance between survival benefits and quality of life in advanced RCC.

02

Conditions studied

  • Metastatic Clear Cell Renal Cell Carcinoma

Keywords

  • Metastatic Clear Cell Renal Cell Carcinoma
  • CD70-Targeted Immuno-PET/CT
  • Treatment Holiday
03

In context

Clear-cell metastatic renal cell carcinoma

70 studies on the registry are indexed under Clear-cell metastatic renal cell carcinoma; 31 are open to participants now.

This study's planned enrollment of 75 is above the median of 39 across 63 interventional studies indexed under Clear-cell metastatic renal cell carcinoma.

Browse Clear-cell metastatic renal cell carcinoma studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

STEP0: At Treatment Initiation

  1. Male or female subjects aged ≥ 18 years
  2. Locally advanced (not amenable to curative surgery or radiation therapy) or RCC (American Joint Committee on Cancer [AJCC] Stage IV)
  3. or cytologically confirmed advanced RCC with predominantly clear-cell subtype
  4. Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
  5. Performance Status (KPS) grade ≥ 70%
  6. At least one on CT per (RECIST) version 1.1
  7. 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
  8. 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
  9. Adequate organ and bone marrow function meeting all laboratory criteria:

    • (ANC) ≥ 1.5 × 10\^9/L; count ≥ 100 × 10\^9/L; ≥90 g/L
    • (ALT) and aspartate aminotransferase (AST) \< 2.5 × (ULN) (or ≤ 5 × ULN if hepatic metastases are present). Total ≤ 1.5 × ULN (≤ 3 mg/dL if Gilbert's syndrome)
    • Serum creatinine ≤ 2.0 × ULN or estimated (eGFR) ≥ 30 mL/min using the formula
  10. Capacity to comprehend and comply with protocol requirements, with documented signed
  11. agreement for sexually active fertile participants and partners to use medically accepted methods during the study and continue for 5 months after last treatment
  12. Negative pregnancy status at screening for women of

STEP1: At 12-Month Evaluation

  1. Patient met all eligibility criteria outlined above
  2. Patient must receive 12 months (±1m) of /PD-L1 ICI + VEGFR-TKI therapy, without permanent discontinuation of both agents due to unmanageable toxicity
  3. Patient must have completed an CD70-targeted immuno-PET/CT scan at 12m (±1m) from start of initial therapy
  4. 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

Exclusion criteria

Exclusion Criteria:

STEP0: At Treatment Initiation

  1. Prior systemic therapy for advanced RCC
  2. Poor risk as per International RCC Database Consortium (IMDC) criteria
  3. Performance Status (KPS) \<70%
  4. Inadequate organ and bone marrow function
  5. Active or unless adequately treated with radiotherapy and/or surgery (including radiosurgery) who are clinically stable without progression prior to treatment
  6. Concurrent or prior invasive 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)
  7. Presence of uncontrolled major comorbidities or recent severe illnesses within 6 months, including but not limited to: uncontrolled hypertension, cardiovascular disease, GI disorders with high risk of perforation/fistula, significant hematuria, hematemesis, hemoptysis, major bleeding history, severe active infections (including active , , or ), or severe diseases (e.g., systemic lupus erythematosus, immune pneumonitis)
  8. \< 6 months
  9. Known allergy or to the CD70 imaging agent or any of its
  10. Severe hepatic or renal insufficiency, or inability to tolerate PET/CT examination
  11. Medical/psychiatric/social conditions compromising protocol compliance
  12. Pregnancy, lactation, or refusal of during and for 5 months post-treatment

STEP1: At 12-Month Evaluation

  1. Failure to complete 12 months(±1m) of /PD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or disease progression
  2. Failure or inability to undergo CD70-targeted immuno-PET/CT scan at the 12-month evaluation timepoint
  3. Unacceptable clinical deterioration or investigator discretion indicating that a treatment holiday is not in the best interest of the patient
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Treatment Holiday Strategy

    Patients with mccRCC who complete 12 months of first-line PD-1/PD-L1 inhibitor plus VEGFR-TKI combination therapy AND achieve the predefined composite response (anatomical CR/PR/SD per RECIST 1.1 AND metabolic CMR/PMR per PERCIST on CD70 immuno-PET/CT) will enter a treatment holiday. Systemic therapy will be suspended, and patients will undergo active surveillance.

    Drug: PD-1/PD-L1 ICI + VEGFR-TKI · Other: Treatment pause

Interventions

  • DrugPD-1/PD-L1 ICI + VEGFR-TKI

    All participants will receive first-line PD-1/PD-L1 inhibitor + VEGFR-TKI combination therapy for 12 months (±1 month).

  • OtherTreatment pause

    Patients who achieve the predefined criteria after 12 months of treatment will discontinue both drugs and enter a closely monitored treatment holiday. Upon radiographic or clinical progression, the previous systemic therapy will be reintroduced according to the protocol and investigator's discretion.

06

What researchers measure

Primary outcomes

  1. Treatment-free survival (TFS) rate

    Defined as the proportion of patients who are alive without having restarted the original therapy at 12 months following discontinuation of the combination therapy.

    Time frame: 12 months after treatment discontinuation

Secondary outcomes

  1. Overall survival (OS)

    Time from enrollment to date of death due to any cause.

    Time frame: From treatment initiation until 3 years of follow-up

  2. Progression free survival (PFS)

    Time from enrollment to first documented disease progression or death, whichever occurs first.

    Time frame: From treatment initiation until 3 years of follow-up

  3. Overall safety profile

    Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 criteria.

    Time frame: From treatment initiation until 3 years of follow-up

  4. Patient-reported outcome (PRO) - Health-related quality of life measured by NCCN FKSI-19

    Measured by the NCCN functional assessment of cancer therapy-kidney symptom index (FKSI-19), a 19-item scale assessing treatment-related symptoms and side effects for kidney cancer patients.

    Time frame: From treatment initiation until 2 years of follow-up

  5. Patient-reported outcome (PRO) - Health-related quality of life measured by EORTC QLQ-C30

    Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), a 30-item instrument assessing various domains of physical, emotional, and social functioning for cancer patients.

    Time frame: From treatment initiation until 2 years of follow-up

  6. Patient-reported outcome (PRO) - General Health status measured by EQ-5D-5L

    Measured by the "5-Level EuroQol Group's 5-Dimension" (EQ-5D-5L) questionnaire which comprises the EQ-5D index evaluating health across five dimensions and the EQ-VAS which is a 0-100 visual scale for self-rated overall health.

    Time frame: From treatment initiation until 2 years of follow-up

  7. Patient-reported outcome (PRO) - Anxiety and depression status measured by HADS

    Measured by the Hospital Anxiety and Depression Scale (HADS) which contains 14 items with 7 items measuring anxiety level and 7 items measuring depression level.

    Time frame: From treatment initiation until 2 years of follow-up

  8. Quality-adjusted life years (QALYs)

    The quality-adjusted time without symptoms or toxicity (Q-TWiST) integrates data from patient-reported outcomes (PROs) into survival calculations. It quantifies the utility-weighted sum of mean time across three health states: time with all-cause grade 3/4 toxicity prior to progression, time without grade 3/4 toxicity or symptoms of progression, and time after progression.

    Time frame: From treatment initiation until 2 years of follow-up

  9. Cost-effectiveness

    Measured by the incremental cost-effectiveness ratio (ICER) to provide the ratio of incremental cost per additional quality-adjusted life year (QALY).

    Time frame: From treatment initiation until 2 years of follow-up

  10. Duration of response (DoR)

    Time from first documented complete metabolic response (CMR) or partial metabolic response (PMR) to progression or death.

    Time frame: From treatment discontinuation until 2 years of follow-up

  11. Distribution of treatment modality after progression

    Proportion of participants receiving surveillance, focal treatment, or systemic therapy after disease progression.

    Time frame: From treatment discontinuation until 2 years of follow-up

  12. Objective response rate (ORR) after restarting treatment

    Proportion of participants achieving objective response within 6 months of restarting therapy after progression.

    Time frame: From treatment discontinuation until 2 years of follow-up

  13. Time to subsequent therapy initiation

    Time from treatment discontinuation to the start of subsequent systemic therapy or death, whichever occurs first.

    Time frame: From treatment discontinuation until 2 years of follow-up

07

Study locations

5 of 5 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Aug 2028, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2026
First posted
May 29, 2026
StartActual
Jun 16, 2026
Primary completionEst.
Aug 10, 2028
CompletionEst.
Aug 10, 2029
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07615348
Responsible party
Le Qu (Associate chief urologist, Jinling Hospital, China) — Principal investigator
First posted
May 29, 2026
Start date
Jun 16, 2026
Primary completion
Aug 10, 2028 (estimated)
Completion
Aug 10, 2029 (estimated)
Last update
Aug 11, 2026

Study contacts

Le Qu, Ph.D.
Contact
septsoul@hotmail.com
+86 15720625951
Le Qu, Ph.D.
principal investigator · Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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