Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma

NCT02575222 | Completed Phase 1 DMC

• 2 other identifiers: J15179IRB00068726
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

Immunotherapy; PD-1; anti-PD-1; antibody; Kidney Cancer; RCC; non-metastatic

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by number of participants experiencing adverse events

  Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

  From the first dose of nivolumab treatment through 100 days post-surgery

Secondary Outcomes (5)

• Objective Tumor Response Rate (by RECIST)

  Assessed at baseline, prior to surgery, and 3 months after surgery

• Objective Tumor Response Rate (by irRC)

  Assessed at baseline, prior to surgery, and 3 months after surgery

• Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire

  Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery

• Metastasis-Free Survival

  12 months post-operatively, then every 6 months for 5 years

• Overall Survival

  12 months post-operatively, then every 6 months for 5 years

Study Arms (1)

Nivolumab

EXPERIMENTAL

3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.

Drug: Nivolumab

Interventions

Nivolumab DRUG

3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.

Also known as: MDX-1106, BMS-936558, Opdivo

Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0)
• Schedule to undergo either partial or radical nephrectomy as part of treatment plan
• Patient agrees to have a tumor biopsy
• ECOG performance status of 0 or 1
• Adequate organ and marrow function defined by study-specified laboratory tests
• Must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion
• Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures

You may not qualify if:

• Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
• Need for urgent or emergent nephrectomy to relieve symptoms
• Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
• Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
• Received live vaccine for infectious diseases within 28 days of starting study treatment
• Prior treatment with any antibody or drug targeting T-cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
• Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug.
• Current use of immunosuppressive agents
• History of severe hypersensitivity reaction to other monoclonal antibodies
• Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
• Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
• Active infection requiring therapy.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
• Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
• History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mohamad E Allaf, M.D

  Department of Urology and The Brady Urological Institute at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 14, 2015
• Study Start: February 1, 2016
• Primary Completion: June 9, 2020
• Study Completion: June 9, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)