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Nivolumab with Surgery for Kidney Cancer (PROSPER Trial)

Phase 3

Waitlist Available

Led By Lauren Harshman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have a renal mass consistent with a clinical stage >= T2Nx renal cell carcinoma (RCC) or TanyN+ RCC for which radical or partial nephrectomy is planned

Patients must not have any prior systemic or local anti-cancer therapy for the current RCC

Must not have

Patient must not have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Patient must be >= 18 years of age. Because no dosing or adverse event data are currently available on the use of nivolumab therapy in patients < 18 years of age, children are excluded from this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether nephrectomy plus nivolumab is better than nephrectomy alone at treating patients with localized kidney cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Nivolumab may cause immune-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), liver issues, and could potentially worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

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

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

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I have not received any treatment for my current kidney cancer.

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I have not been treated for kidney cancer with the aim of cure in the last 5 years.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I do not have a serious illness or an active infection needing IV antibiotics.

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I have not had any major surgery in the last 28 days.

Exclusion Criteria

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

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

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I am 18 years old or older.

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My cancer has not spread to my liver, bones, or brain.

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I have not had a partial kidney removal for my kidney cancer.

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I have not received any cancer treatment for kidney cancer.

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I have up to 3 cancer spread sites that can be treated within 3 months after my main tumor is removed.

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My biopsy after joining the study did not show renal cell carcinoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Recurrence-free Survival (RFS) Rate at 5 Years

Secondary study objectives

Overall Survival Rate at 5 Years

Recurrence-free Survival (RFS) Rate at 3 Years Among Patients With Clear Cell Histology

Other study objectives

Association Between the Expression of PD-L1 on Tumor Tissue at Nephrectomy as Well as Recurrence and Outcome

Association Between the Primary Tumor's Expression of PD-L1 With Outcome

To Archive Images for Potential Central Confirmation of Recurrence and for Future Correlative Work

+6 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 A (nivolumab + nephrectomy)Experimental Treatment4 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 Control4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nephrectomy

2013

Completed Phase 3

~11310

Nivolumab

2015