Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Michael B. Atkins, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.

Research Team

Michael B. Atkins, MD

Principal Investigator

Hoosier Cancer Research Network

Eligibility Criteria

Inclusion Criteria

Archival tissue of a metastatic lesion obtained within 1 year prior to study registration (within 4 weeks preferred) and tumor tissue from nephrectomy is required if available

You must have a minimum number of white blood cells (WBC) which is 2000 per microliter.

Histologically confirmed advanced RCC (any histology) excluding collecting duct tumors and tumors originating from the renal pelvis or upper urinary tract

Exclusion Criteria

Active brain metastases or leptomeningeal metastases

Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

You have any other medical or personal condition that the study doctor thinks might make it unsafe for you to participate or might make it hard for you to follow the rules of the study.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)

Participant Groups

Group I: PART B: Nivolumab + Ipilimumab Experimental Treatment 3 Interventions

Nivolumab 3mg/kg and Ipilimumab 1mg/kg; Nivolumab 360mg

Group II: PART A: Nivolumab Experimental Treatment 2 Interventions

Nivolumab 240mg; Nivolumab 360mg

Nivolumab is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Michael B. Atkins, MD

Lead Sponsor

Trials

2

Recruited

280+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Hoosier Cancer Research Network

Collaborator

Trials

69

Recruited

3,800+

Brian Stemme

Hoosier Cancer Research Network

Chief Executive Officer since 2022

Bachelor's degree from Butler University

Noah Hahn

Hoosier Cancer Research Network

Chief Medical Officer since 2023

MD