What is this trial studying for metastatic kidney cancer?

This clinical trial is evaluating whether adding surgery to remove the kidney improves overall survival compared to immunotherapy-based drug treatment alone in patients with metastatic kidney cancer. It compares different combinations of immunotherapy drugs with or without surgery to understand the best approach. The research is sponsored by the SWOG Cancer Research Network.

Who may be eligible for this metastatic kidney cancer clinical trial?

Adults aged 18 or older with a confirmed diagnosis of clear cell or non-clear cell renal cell carcinoma may be eligible. Participants should have measurable metastatic disease and no active brain metastases. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic kidney cancer clinical trial?

Study-related care, including the study drugs, surgery, and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID04510597

Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma PROBE Trial

Led by SWOG Cancer Research Network · Updated on 2025-09-09

364

Participants Needed

387

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating treatments for patients with metastatic kidney cancer, focusing on whether adding surgery to a standard immunotherapy-based drug combination improves overall survival. This phase III trial compares outcomes for patients receiving immunotherapy with or without surgery to remove the kidney, known as nephrectomy. Immunotherapy drugs like nivolumab, ipilimumab, pembrolizumab, and avelumab aim to help the immune system attack the cancer, while axitinib works to block tumor growth. The benefit of adding surgery to these drug treatments is not yet established. Participants first receive one of three standard immunotherapy-based regimens before randomization, including combinations of intravenous nivolumab, ipilimumab, pembrolizumab, avelumab, and oral axitinib. After about 10 to 14 weeks of this initial treatment, patients are randomly assigned to continue systemic therapy alone or to receive surgery to remove the kidney plus the same systemic therapy. Surgery may be radical or partial and performed using laparoscopic, open, or robotic methods within 8 weeks of randomization. Axitinib is paused before surgery and resumed after recovery. Throughout the study, participants undergo scans and clinical assessments to monitor tumor response and side effects. After completing treatment, patients are followed up every 3 months during the first year, then every 6 months for years two and three, and annually thereafter for up to seven years. The trial measures overall survival, tumor response in metastatic sites, changes in tumor size, and complications from surgery or drug toxicities. Specimens are also collected for future research to better understand the disease and treatments.

CONDITIONS

Brief Title

Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants must have a confirmed diagnosis of clear cell or non-clear cell renal cell carcinoma (collecting duct carcinoma is excluded).
Participants must have their primary tumor in place.
Participants must have recent CT or MRI scans showing metastatic disease within 90 days before registration or treatment start.
Participants must have no clear contraindications to nephrectomy.
Participants must be offered participation in specimen banking and provide informed consent.
Participants must have an objective status of stable disease, partial response, or clinical benefit after 12 weeks of pre-randomization treatment.
Participants must plan to continue immune-based therapy and be randomized within weeks 11 to 14 of pre-randomization treatment.
Participants must have received minimum amounts of immunotherapy prior to randomization.
Participants must be surgical candidates as determined by a urologist.
Participants must have a performance status of 0-1 and meet certain lab value limits within 28 days before randomization.

You will not qualify if you...

Participants with known active brain metastases are excluded, except those previously treated without symptoms.
Participants must not have received prior systemic therapy beyond specified limits before the study.
Participants must not have received immunotherapy within one year before registration.
Participants must not have a solitary or transplanted kidney.
Participants with other prior malignancies are excluded unless adequately treated and disease-free for at least two years.
Participants previously diagnosed with medical conditions making them ineligible for immune-based therapy or nephrectomy are excluded.
Participants showing progression in the primary tumor at randomization are excluded unless deemed pseudoprogression.
Participants with contraindications to nephrectomy or immune-based therapy are excluded.

Research Team

Megan Keim, MS

Dana Sparks, MAT

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