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Monoclonal Antibodies

Immunotherapy With or Without Surgery for Kidney Cancer (PROBE Trial)

Phase 3

Recruiting

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have primary tumor in place

Participants must have at least one of the specified scans performed 12 weeks (+/- 2 weeks) after starting pre-randomization treatment. Response should be assessed by comparing with a CT or MRI of the chest, abdomen and pelvis obtained prior to starting pre-randomization treatment. Participants with complete response in all metastatic sites are not eligible to randomize to Step 2

Must not have

Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy

Participants must not have received specific prior treatment of metastatic renal cell carcinoma based on treatment history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare immunotherapy plus surgery to immunotherapy alone to see if it is more effective in treating kidney cancer.

Who is the study for?

This trial is for patients with metastatic kidney cancer who have already started immunotherapy. They must have had certain minimum treatments, be able to continue immunotherapy, and be fit for surgery to remove the kidney. People can't join if they've had too much pre-trial treatment, other cancers (with some exceptions), active brain metastases, or conditions that rule out immunotherapy or surgery.

What is being tested?

The PROBE Trial is testing whether adding a surgical procedure called cytoreductive nephrectomy (kidney removal) to standard care immunotherapies like nivolumab, ipilimumab, pembrolizumab, and avelumab improves outcomes in metastatic kidney cancer compared to just the drug combination alone.

What are the potential side effects?

Immunotherapies may cause immune-related side effects such as inflammation of organs; skin reactions; endocrine issues like thyroid problems; fatigue; flu-like symptoms; and infusion reactions. Surgery carries risks of bleeding, infection, pain at the incision site and potential complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My primary cancer tumor has not been removed.

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I've had a scan 10-14 weeks after starting treatment showing how my cancer has responded.

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I have had CT scans or MRIs showing cancer spread in my chest, abdomen, or pelvis.

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I have received at least one round of immunotherapy.

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I've had the required scans 12 weeks after starting my initial treatment and not all cancer sites are completely gone.

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I have received the minimum required immunotherapy treatments.

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I plan to keep taking the immune therapy I started before joining the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no medical conditions that prevent me from receiving immune therapy or kidney removal.

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I have not received treatments specifically for metastatic kidney cancer.

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I have two functioning kidneys and none of them are transplanted.

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I have no other cancers, except for those that were treated successfully.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Secondary study objectives

Change in maximum diameter of primary tumor

Objective response

Overall survival in subset who received assigned protocol treatment

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: Nephrectomy and Continued Systemic TherapyExperimental Treatment1 Intervention

Continued systemic therapy as above, plus: Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization.

Group II: Arm 1: Continued Systemic Therapy OnlyActive Control2 Interventions

Nivolumab 240 mg IV 1 q 2 weeks OR Nivolumab 480 mg IV 1 q 4 weeks OR Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID OR Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID

0 / 11Eligibility criteria met