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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

PROBE 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.Check my eligibility

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.See study design

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.

PROBE Trial 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.

Select...

I have received the minimum required immunotherapy treatments.

Select...

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

PROBE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival

Secondary outcome measures

Change in maximum diameter of primary tumor

Objective response

Overall survival in subset who received assigned protocol treatment

+1 more

PROBE 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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,447 Total Patients Enrolled

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

264,806 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,490 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04510597 — Phase 3

Renal Cell Carcinoma Research Study Groups: Arm 1: Continued Systemic Therapy Only, Arm 2: Nephrectomy and Continued Systemic Therapy

Renal Cell Carcinoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04510597 — Phase 3

Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04510597 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are participating in this research?

"There are 100 hospitals participating in this trial, with locations such as Marshfield Medical Center-Marshfield, The Carle Foundation Hospital and Marshfield Clinic - Ladysmith Center."

Answered by AI

Are people still being allowed to sign up for this experiment?

"The clinical trial is currently looking for patients, as indicated by the information on clinicaltrials.gov. This research was initially posted on 11/16/2020 and was edited most recently on 11/9/2022. The study plans to enroll 364 participants from 100 sites in total."

Answered by AI

How many individuals are being included in this experiment?

"To successfully conduct this trial, 364 individuals that meet the pre-determined inclusion criteria must enroll. These patients can come from many places, but two example locations are Marshfield Medical Center-Marshfield in Marshfield, Illinois and The Carle Foundation Hospital in Urbana, Minnesota."

Answered by AI