Clinical trial · Interventional
Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy
A Prospective Study of Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy vs Primary Tumour in Place
NCT05941169CI-TRIAL-00067934PrimerXnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The benefit of deferred Cytoreductive Nephrectomy (CN) has to be re-assessed in the context of IO +IO and IO + TKI systemic treatment. Given the benefit of CN in the setting of first generation immunotherapy, it is conceivable that both trials underestimated the benefit of CN, in absence of immunotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytoreductive Nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cytoreductive Nephrectomy
- description
- Cytoreductive Nephrectomy within 6 months to 1 year after start systemic therapy for metastatic Renal Cell Carcinoma
- interventionNames
- Procedure: Cytoreductive Nephrectomy
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Standard of Care for metastatic Renal Cell Carcinoma
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- defined as time from randomization to death of any cause during 5 years of follow-up
- description
- Overall Survival Using Kaplan Meier Survival analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients age ≥ 18 years 2. Signed and written informed consent Note: Written and signed informed consent will be obtained before any study procedures, including study-specific-screening procedures, has been performed. 3. Informed consent obtained for being offered future experimental interventions within the PRO-RCC project. 4. Histologically confirmed diagnosis of metastatic clear cell, papillary or chromophobe renal cell carcinoma of intermediate to poor risk, including sarcomatoid features, with 5. World Health Organization (WHO) performance status of 0-1. 6. Surgical candidates based on surgeon and anesthetist assessment 7. Treatment with an IO combination (IO+IO or IO+TKI) as standard of care for metastatic RCC 8. Absence of progression at metastatic sites at time of identification (6month after start of systemic first line treatment). 9) Primary tumor in situ 10) Participation in the PRO-RCC prospective cohort. Exclusion Criteria: NA
References
Publications (1)
- DERIVEDFigaroa O, Zondervan P, Kessels R, Berkhof J, Aarts M, Hamberg P, Los M, Piersma D, Rikhof B, Suelmann B, Tascilar M, van der Veldt A, Verhagen P, Westgeest H, Yildirim H, Bex A, Bins A. PrimerX: A Bayesian Multistage Cohort Embedded Randomised Trial to Evaluate the Role of Deferred Local Therapy of the Primary Tumour in Combination with Immune Checkpoint Inhibitor-based First-line Therapy in Metastatic Renal Cell Carcinoma Patients. Eur Urol Open Sci. 2024 Oct 14;70:28-35. doi: 10.1016/j.euros.2024.09.002. eCollection 2024 Dec. PMID 39483517