Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab/Nivolumab in mRCC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
The goal of this clinical trial is to learn whether the timing of surgery (cytoreductive nephrectomy) improves outcomes when combined with immunotherapy (ipilimumab and nivolumab) in adults with metastatic clear cell renal cell carcinoma.
The main questions this study aims to answer are:
* Does upfront (immediate) surgery before immunotherapy improve survival compared to delayed surgery after immunotherapy? * What medical problems (side effects or complications) occur with each treatment sequence? * How do the two strategies affect quality of life?
Researchers will compare two groups:
* Upfront surgery group: Participants will have surgery first, then receive 4 cycles of ipilimumab/nivolumab, followed by nivolumab maintenance. * Deferred surgery group: Participants will receive 4 cycles of ipilimumab/nivolumab first, then surgery, followed by nivolumab maintenance.
Participants will:
* Be randomly assigned to one of the two groups * Undergo regular clinic visits, imaging tests, and blood collections for safety and biomarker studies * Be followed for 15 months to check disease progression, complications, survival, and quality of life
This trial will help determine the best timing for surgery in the era of immunotherapy and provide evidence for improved treatment strategies for patients with metastatic kidney cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 19 years (male or female).
Histologically confirmed synchronous metastatic clear cell renal cell carcinoma.
ECOG performance status 0-1.
At least one measurable metastatic lesion (per RECIST v1.1).
Disqualifiers
Prior systemic therapy for metastatic RCC.
History of another malignancy diagnosed or treated within 2 years (except for cured non-melanoma skin cancer or in-situ cancers).
History or suspicion of autoimmune disease incompatible with immune checkpoint inhibitor therapy.
Requirement for systemic corticosteroid therapy >10 mg/day prednisone equivalent, or other immunosuppressive drugs.
Trial design
Design model
Parallel
Treatments tested in this trial
Ipilimumab plus Nivolumab
DrugParticipants will receive 4 cycles of ipilimumab combined with nivolumab as induction therapy, followed by nivolumab maintenance depending on randomization schedule (before or after surgery).
Cytoreductive Nephrectomy
Procedure/SurgerySurgical removal of the primary kidney tumor (cytoreductive nephrectomy), performed either upfront (before systemic therapy) or deferred (after 4 cycles of ipilimumab/nivolumab induction), depending on randomization arm.
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: Upfront Cytoreductive Nephrectomy (CN)Experimental treatment 2 interventions
Group B: Deferred Cytoreductive Nephrectomy (CN)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS) assessed by RECIST version 1.1
Time from randomization to first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to RECIST version 1.1 criteria and clinical evaluation.
Time frame
Up to 15 months after treatment initiationSecondary outcomes
1
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame
Up to 15 months after treatment initiation2
Rate and Severity of Perioperative Complications Assessed by Clavien-Dindo Classification
Proportion of patients experiencing perioperative complications graded using the Clavien-Dindo classification (Grades I-V).
Time frame
Within 90 days after cytoreductive nephrectomy3
Rate and Severity of Perioperative Adverse Events Assessed by CTCAE v4.0
Severity of postoperative adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Grade 1-5).
Time frame
Within 90 days after cytoreductive nephrectomy4
Radiologic Tumor Response Rate Assessed by RECIST v1.1
Rate of complete response (CR) and partial response (PR) to ipilimumab/nivolumab, assessed using RECIST version 1.1.
Time frame
At baseline, at 12 weeks (after 4 cycles of ipilimumab/nivolumab induction therapy), and every 12 weeks thereafter up to 15 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: