Nivolumab with Surgery for Kidney Cancer

(PROSPER Trial)

Recruiting at471 trial locations

Overseen by Lauren Harshman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with nivolumab to the usual approach of nephrectomy followed by standard post-operative follow-up and monitoring, in treating patients with kidney cancer that is limited to a certain part of the body (localized). Nivolumab is a drug that may help stimulate the immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent the cancer from returning. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

Research Team

Lauren Harshman

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

Adults with localized kidney cancer (stage T2 or higher, without distant metastases) who are planning to have a kidney removed and haven't had prior cancer treatments. Participants should not have serious illnesses, active infections needing IV antibiotics, HIV, or be on high-dose steroids. They must not be pregnant/breastfeeding and agree to use contraception.

Inclusion Criteria

Patient must not have any known medical condition (e.g. a condition associated with uncontrolled diarrhea such as ulcerative colitis or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of safety results

Patient must not be currently enrolled in other clinical trials testing a therapeutic intervention

I am scheduled for kidney surgery due to a large tumor or one that has spread to lymph nodes.

Exclusion Criteria

A non-diagnostic biopsy is considered a good faith effort and does not need to be repeated unless deemed clinically necessary by the treating investigator

I have not been treated with specific immune system targeting drugs.

I am 18 years old or older.

Treatment Details

Interventions

• Nephrectomy (Surgery)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview The trial is testing if adding the drug Nivolumab after removing part or all of a kidney can prevent cancer from returning better than just surgery alone. Nivolumab boosts the immune system's ability to fight remaining cancer cells post-surgery.

Participant Groups

Group I: Arm A (nivolumab + nephrectomy) Experimental Treatment 4 Interventions

Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (nephrectomy only) Active Control 4 Interventions

Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Dr. Janet Dancey

Canadian Cancer Trials Group

Chief Medical Officer since 2014

MD, FRCPC

Susan Marlin

Canadian Cancer Trials Group

Chief Executive Officer since 2012

BSc (Hons) from Dalhousie University, MSc in Community Health and Epidemiology from Queen’s University