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

Primary Purpose

Clear Cell Renal Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nivolumab

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma focused on measuring Immunotherapy, PD-1, anti-PD-1, antibody, Kidney Cancer, RCC, non-metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (abbreviated):

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

Exclusion Criteria (abbreviated):

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).
Pulse oximetry of <92% on room air
Pregnant or breastfeeding women

Sites / Locations

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Objective Tumor Response Rate (by RECIST)

Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST)

Objective Tumor Response Rate (by irRC)

Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)

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

Total score range 0-60 with higher scores indicating a less symptomatic respondent.

Metastasis-Free Survival

Number of months without evidence of metastasis.

Overall Survival

Number of months alive.

Full Information

NCT ID

NCT02575222

First Posted

October 6, 2015

Last Updated

June 10, 2020

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02575222

Brief Title

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

Official Title

Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

June 9, 2020 (Actual)

Study Completion Date

June 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clear Cell Renal Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

MDX-1106, BMS-936558, Opdivo

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety as assessed by number of participants experiencing adverse events

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Objective Tumor Response Rate (by RECIST)

Description

Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST)

Time Frame

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

Title

Objective Tumor Response Rate (by irRC)

Description

Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)

Time Frame

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

Title

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

Description

Total score range 0-60 with higher scores indicating a less symptomatic respondent.

Time Frame

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

Title

Metastasis-Free Survival

Description

Number of months without evidence of metastasis.

Time Frame

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

Title

Overall Survival

Description

Number of months alive.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (abbreviated): 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 Exclusion Criteria (abbreviated): 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). Pulse oximetry of <92% on room air Pregnant or breastfeeding women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamad E Allaf, M.D

Organizational Affiliation

Department of Urology and The Brady Urological Institute at Johns Hopkins

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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