Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy

Renal Cell Carcinoma Clinical Trial

— PrimerX  

Official title:

A Prospective Study of Primary Metastatic Renal Cell Carcinoma Treated With Immunecheckpoint Inhibitors and Cytoreductive Nephrectomy vs Primary Tumour in Place

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941169
• Other study ID #: 83948
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: April 1, 2031

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Adriaan Bins, MD PhD
• Phone: 020 5665955
• Email: a.d.bins[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: April 1, 2031
• Est. primary completion date: April 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• Cytoreductive Nephrectomy
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical data and annotated tissue for translational research into mechanisms of treatment response and resistance.	In 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.	post-operative follow-up period during 5 years
Primary	Overall Survival	Overall Survival Using Kaplan Meier Survival analysis	defined as time from randomization to death of any cause during 5 years of follow-up
Secondary	Long term Quality of Life outcomes using validated EORTC Quality of Life Questionnaire (QLQ-C30)	using the Dutch validated EORTC Quality of Life Questionnaire (QLQ-C30)	Post operative follow-up period during 5 years
Secondary	Surgical morbidity outcomes using Clavien Dindo classification of surgical morbidity	Clavien Dindo classification of surgical morbidity is used to classify morbidity outcomes	Post operative follow-up period during 5 years