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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05941169
Acronym
PrimerX
Enrollment
750
Registered
2023-07-12
Start date
2023-08-01
Completion date
2031-04-01
Last updated
2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Cytoreductive Nephrectomy, Immunotherapy, Tyrosine Kinase Inhibitor

Brief summary

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.

Detailed description

In past years, much research has been done into the beneficial effects of cytoreductive nephrectomy in patients with metastatic renal cancer receiving systemic therapy with positive results. In the meantime systhemic therapy, and in particular immunotherapy, have changed. Patients with metastatic renal cancer are increasingly treated with immunocheckpoint inhibitors, but the effect of adding cytoreductive nephrectomy in this group of patients has not yet been investigated. The aim of this study is to investigate whether performing a cytoreductive nephrectomy has a beneficial effect on overall survival in patients with metastatic renal cancer receiving systemic therapy using immunocheckpoint inhibitors. A randomized controlled trial. All eligible patients have already been enrolled in the PRO-RCC registry, a registry that collects prospective observational data, and have also given consent to be included in other studies as a control cohort. This design is called a TWiC (trial within cohort). After randomization, patients who are randomized into the therapy arm will receive a patient information via their treating physician. Upon participation, an informed consent will be signed and the patient will be scheduled for surgery.

Interventions

The experimental intervention consists of cytoreductive nephrectomy (CN) or any ablative local therapy within 6 months and 1 year after start of systemic treatment. All types of ablative local therapy are allowed as a substitute for CN

Sponsors

Comprehensive Cancer Centre The Netherlands
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Survivaldefined as time from randomization to death of any cause during 5 years of follow-upOverall Survival Using Kaplan Meier Survival analysis

Secondary

MeasureTime frameDescription
Long term Quality of Life outcomes using validated EORTC Quality of Life Questionnaire (QLQ-C30)Post operative follow-up period during 5 yearsusing the Dutch validated EORTC Quality of Life Questionnaire (QLQ-C30)
Surgical morbidity outcomes using Clavien Dindo classification of surgical morbidityPost operative follow-up period during 5 yearsClavien Dindo classification of surgical morbidity is used to classify morbidity outcomes

Other

MeasureTime frameDescription
Clinical data and annotated tissue for translational research into mechanisms of treatment response and resistance.post-operative follow-up period during 5 yearsIn detail, we will examine the intratumor alteration of tumor infiltrating CD8, CD4, NK(T) cells (CD56+,CD3+-), and the distribution of these NK cells in the tumor, as these cells have been shown to be involved in anti-tumor responses in RCC.

Contacts

Primary ContactAdriaan Bins, MD PhD
a.d.bins@amsterdamumc.nl020 5665955
Backup ContactAxel Bex, MD PhD
a.bex@nki.nl020 512 9111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026