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Monoclonal Antibodies

Immunotherapy-Based Drug Combination Therapy for Kidney Cancer(PROBE Trial)

Southeastern Medical Oncology Center-Clinton, Clinton, NC
Targeting 3 different conditionsCytoreductive Nephrectomy +1 morePhase 3RecruitingResearch Sponsored by Southwest Oncology Group

PROBE Trial Summary

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

Eligible Conditions
  • Renal Cell Carcinoma
  • Kidney Cancer

PROBE Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You must have the original tumor in its original location.
You need to have specific scans done within a certain timeframe that show evidence of cancer spreading to other parts of the body.
If you have cancer that has spread and you are experiencing symptoms, you may have had or will receive radiotherapy to help with those symptoms.
Your recent lab test results need to meet specific requirements.
You need to have certain scans done 12 weeks after starting treatment to see how well it's working. If the scans show that all the cancer has disappeared, you can't take part in the next part of the study.
After 12 weeks of treatment before randomization, your disease should be stable or have shown partial response. Your doctor must also believe that you are benefiting from the treatment and your overall physical condition should be good.
You have received at least a certain amount of a specific type of immunotherapy.
You must have clear cell or non-clear cell renal cell carcinoma, but not collecting duct carcinoma. If you have tumors in more than one place or on both sides, you can still participate.

PROBE Trial Timeline

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

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.

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

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
262,429 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
393 Previous Clinical Trials
265,538 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,490 Previous Clinical Trials
41,266,351 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, Illinois and The Carle Foundation Hospital in Urbana, Minnesota."

Answered by AI

Has the FDA cleared Cytoreductive Nephrectomy for use?

"Cytoreductive Nephrectomy received a score of 3 due to the presence of data supporting its efficacy and safety from multiple sources."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~243 spots leftby Jul 2033