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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02575222
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : June 12, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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).

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Drug: Nivolumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma
Actual Study Start Date : February 2016
Actual Primary Completion Date : June 9, 2020
Actual Study Completion Date : June 9, 2020


Arm Intervention/treatment
Experimental: Nivolumab
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
3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
Other Names:
  • MDX-1106
  • BMS-936558
  • Opdivo




Primary Outcome Measures :
  1. Safety as assessed by number of participants experiencing adverse events [ Time Frame: From the first dose of nivolumab treatment through 100 days post-surgery ]
    Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)


Secondary Outcome Measures :
  1. Objective Tumor Response Rate (by RECIST) [ Time Frame: Assessed at baseline, prior to surgery, and 3 months after surgery ]
    Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST)

  2. Objective Tumor Response Rate (by irRC) [ Time Frame: Assessed at baseline, prior to surgery, and 3 months after surgery ]
    Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)

  3. Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire [ Time Frame: Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery ]
    Total score range 0-60 with higher scores indicating a less symptomatic respondent.

  4. Metastasis-Free Survival [ Time Frame: 12 months post-operatively, then every 6 months for 5 years ]
    Number of months without evidence of metastasis.

  5. Overall Survival [ Time Frame: 12 months post-operatively, then every 6 months for 5 years ]
    Number of months alive.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (abbreviated):

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

Exclusion Criteria (abbreviated):

  1. Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
  2. Need for urgent or emergent nephrectomy to relieve symptoms
  3. Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
  4. Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
  5. Received live vaccine for infectious diseases within 28 days of starting study treatment
  6. 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)
  7. Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug.
  8. Current use of immunosuppressive agents
  9. History of severe hypersensitivity reaction to other monoclonal antibodies
  10. Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
  11. Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
  12. Active infection requiring therapy.
  13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  14. Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
  15. History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply).
  16. Pulse oximetry of <92% on room air
  17. Pregnant or breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575222


Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
Investigators
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Principal Investigator: Mohamad E Allaf, M.D Department of Urology and The Brady Urological Institute at Johns Hopkins
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02575222    
Other Study ID Numbers: J15179
IRB00068726 ( Other Identifier: JHMIRB )
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Immunotherapy
PD-1
anti-PD-1
antibody
Kidney Cancer
RCC
non-metastatic
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents