Deferred surgery for kidney cancer with metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of deferred cytoreductive nephrectomy in patients with synchronous metastatic renal cell carcinoma (RCC). Participants will receive initial immunotherapy with nivolumab and ipilimumab or a TKI/IO combination before being evaluated for surgery after three months. The study aims to determine whether delaying surgery improves overall survival compared to immediate surgery, particularly focusing on patients with intermediate risk factors. The trial includes a randomization process for those eligible for surgery based on their risk assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent obtained prior to any study specific procedures.
2. Patient must be willing and able to comply with the protocol.
3. Age ≥18.
4. Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable.
5. Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.
6. Measurable disease as per RECIST v 1.1
7. Patients for which Nivolumab/Ipilimumab or a TKI/IO-combination is considered indicated according to the recommendations by the European Medicines Agency and the national health authorities of participating countries. The prescription of nivolumab/ipilimumab or a TKI/IO-combination in the circumstances of the study is considered as a standard treatment.
8. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
9. Fertile women of childbearing potential (\<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
10. Karnofsky Performance status ≥70
11. Life expectancy of greater than 4 months.
12. The required laboratory values are as follows:

    * Adequate bone marrow function (Leucocytes \> 3.0 x 109/l, platelets \> 100 x 109/l, hemoglobin \> 6.0 mmol/l or \> 10.0 g/dL.)
    * International normalized ratio (INR) ≤ 1.2 x upper limit of normal (ULN)
    * Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALAT ≤ 2.5 x ULN or ≤ 5 x ULN if liver lesions)
    * Adequate kidney function (eGFR \> 35 mL/min)

Exclusion Criteria:

1. Prior systemic treatment for mRCC
2. Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA).
3. Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment
4. Clinically significant (i.e active) cardiovascular disease for example cerebrovascular accidents (\< 6 months before inclusion), myocardial infarction (\< 6 months before inclusion), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure.
5. No symptomatic brain metastasis requiring systemic corticosteroids (\> 10 mg daily prednisone equivalent)
6. Recent (within the 30 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.
7. Any active or recent history of a known or suspected autoimmune disease or recent history of a condition that require systemic corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications, excluding inhaled steroids and topical steroids. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, psoriasis not requiring systemic treatment are permitted to enroll.
8. Known hypersensitivity to monoclonal antibodies.
9. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
10. Any positive test for hepatitis B- or C-Virus indicating acute or chronic infection.
11. Oral or i.v. antibiotics administered 14 days prior to initiation of systemic therapy.

Where it's running

• Department of Oncology, Aarhus University Hospital
  Aarhus, Central Region of Denmark, Denmark Recruiting
• Department of Oncology, Herlev Hospital
  Herlev, Denmark Recruiting
• Department of Oncology, Odense University Hospital
  Odense, Denmark Recruiting
• Clinical Trial Unit, Helsinki University Central Hospital
  Helsinki, Finland Recruiting
• Center for Cancer and Blood Diseases, Vestfold Hospital Trust
  Tønsberg, Vestfold, Norway Recruiting
• Department of Oncology, Ålesund Universitetsykehus
  Ålesund, Norway Recruiting

Study contacts

• Principal investigator: Niels Fristrup, MD PhD — Department of Oncology, Aarhus University Hospital.
• Study coordinator: Niels Fristrup, MD PhD
• Email: niels.fristrup@rm.dk
• Phone: 004520914161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.