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

NCT ID: NCT05941169

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2031-04-01

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cytoreductive Nephrectomy

Cytoreductive Nephrectomy within 6 months to 1 year after start systemic therapy for metastatic Renal Cell Carcinoma

Group Type: EXPERIMENTAL

Cytoreductive Nephrectomy

Intervention Type: PROCEDURE

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

Standard of Care

Standard of Care for metastatic Renal Cell Carcinoma

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comprehensive Cancer Centre The Netherlands

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Adriaan D. Bins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriaan Bins, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Central Contacts

Adriaan Bins, MD PhD

Role: CONTACT

a.d.bins@amsterdamumc.nl

020 5665955

Axel Bex, MD PhD

Role: CONTACT

a.bex@nki.nl

020 512 9111

References

Figaroa 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.

Reference Type: DERIVED

PMID: 39483517 (View on PubMed)

Other Identifiers

83948

Identifier Type: -

Identifier Source: org_study_id