Clinical trial NCT02982954: A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
Official title: Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Cell Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-12-06
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.


Eligibility criteria: Inclusion Criteria:

1. Type of Participant and Target Disease Characteristics

1. Advanced or metastatic RCC
2. Histologically confirmed, previously untreated (treatment-naive) RCC
3. No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
4. Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
5. Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
6. Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.

Exclusion Criteria:

1. Medical Conditions

   1. Subjects with any active autoimmune disease or a history of known autoimmune disease
   2. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
   3. Known HIV or AIDS-related illness
   4. Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
2. Prior/Concomitant Therapy

   1. Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
   2. Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
   3. Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)
timeFrame: Approximately 39 Months
measure: Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)
timeFrame: Approximately 39 Months
Secondary outcomes:
measure: Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
timeFrame: From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)
measure: Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
timeFrame: From the IMAE onset date to the IMAE end date, up to approximately 194 weeks
measure: Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
timeFrame: From first dose up to 100 days post last dose (up to approximately 29 months)
measure: Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
timeFrame: From first dose up to 100 days post last dose (up to approximately 29 months)
measure: Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
timeFrame: From first dose up to 100 days post last dose (up to approximately 29 months)
measure: Median Progression Free Survival (PFS)
timeFrame: From first dose to the date of the first documented progressive disease, up to approximately 12 months
measure: Objective Response Rate (ORR)
timeFrame: From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)
measure: Time to Response Rate (TRR)
timeFrame: From the date of first dose to first documented CR or PR, up to approximately 15 months
measure: Duration of Response (DOR)
timeFrame: From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center, Pc
state: Alabama
city: Anchorage
country: United States
facility: Alaska Urological Institute dba Alaska Clinical Research Center
state: Alaska
city: Chandler
country: United States
facility: Ironwood Cancer And Research Centers, Pc
state: Arizona
city: Fayetteville
country: United States
facility: Local Institution - 0028
state: Arkansas
city: Encinitas
country: United States
facility: eCare
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: Los Angeles Cancer Network
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology Oncology
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Medical Group - Southern California
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Maria
country: United States
facility: Central Coast Med Oncology
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists S.
state: Florida
city: Miami
country: United States
facility: University Of Miami/Sylvester Cancer Center
state: Florida
city: Orlando
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Emory University - Winship Cancer Institute
state: Georgia
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0012
state: Indiana
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Burnsville
country: United States
facility: Southdale Cancer Clinic
state: Minnesota
city: Coon Rapids
country: United States
facility: Local Institution - 0009
state: Minnesota
city: Minneapolis
country: United States
facility: Park Nicollet Clinic Cancer Center
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Jackson
country: United States
facility: Jackson Oncology Associates, Pllc
state: Mississippi
city: Kansas City
country: United States
facility: HCA Midwest Division
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Hackensack
country: United States
facility: Local Institution - 0023
state: New Jersey
city: Albuquerque
country: United States
facility: University Of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Grand Island
country: United States
facility: St. Francis Cancer Treatment Center
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: New York
country: United States
facility: Local Institution - 0052
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: Local Institution - 0071
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, Pa
state: South Carolina
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC - SCRI - PPDS
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0002
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Fort Worth 12th Ave
state: Texas
city: Midland
country: United States
facility: Texas Oncology-Midland Allison Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Fairfax
country: United States
facility: Local Institution - 0042
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours St Francis Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: University of Washington - Seattle Cancer Care Alliance
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Clinical Science Center
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: George DJ, Spigel DR, Gordan LN, Kochuparambil ST, Molina AM, Yorio J, Rezazadeh Kalebasty A, McKean H, Tchekmedyian N, Tykodi SS, Zhang J, Askelson M, Johansen JL, Hutson TE. Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, open-label, phase IIIb/IV CheckMate 920 trial. BMJ Open. 2022 Sep 14;12(9):e058396. doi: 10.1136/bmjopen-2021-058396.
citation: Tykodi SS, Gordan LN, Alter RS, Arrowsmith E, Harrison MR, Percent I, Singal R, Van Veldhuizen P, George DJ, Hutson T, Zhang J, Zoco J, Johansen JL, Rezazadeh Kalebasty A. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial. J Immunother Cancer. 2022 Feb;10(2):e003844. doi: 10.1136/jitc-2021-003844.