An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
- Registration Number
- NCT02869789
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1041
- Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
- No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
- Tissue or Programmed death-ligand 1 (PD-L1) results available
Cohort 1A Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) score 2 or
- Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
Cohort C Inclusion Criteria:
- High Tumor Mutation Burden
- Untreated brain metastases
- An active malignancy that requires concurrent intervention
- Active, known or suspected autoimmune disease
- Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nivolumab in combination with Ipilimumab Nivolumab in combination with Ipilimumab Specified dose on specified days
- Primary Outcome Measures
Name Time Method Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) From first dose to 100 days post last dose (Up to approximately 29 months) imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= DeathNumber of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) From first dose to 30 days post last dose (Up to approximately 27 months) Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
- Secondary Outcome Measures
Name Time Method Duration of Response (DoR) From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months) DoR is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression per RECIST 1.1, or death due to any cause, whichever occurs first.
CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L) From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months) FACT-L is a quality-of-life questionnaire which includes Lung Cancer Subscale (LCS) that assesses the treatment impact on lung cancer related symptoms in 5 domains: Physical, social/family, emotional, and functional well-being using a 5-point scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) added to obtain total score. The ranges of possible total scores are 0-136 for the FACT-L with a higher score representing better quality of life, improved symptomatology and enhanced physical/functional outcomes. According to Functional Assessment of Chronic Illness Therapy scoring guidelines, in the event of missing responses for some of the questions, scores will be prorated using the average of the other answers in that scale.
Baseline is defined as events that occur before the date/time of first dose. Post treatment visits include follow-up (FU) visit 1, FU visit 2, and subsequent survival FU visits to occur every 3 months up until survival FU visit 18.Overall Survival (OS) From first dosing date to the date of death (Up to approximately 67 months) OS is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive.
Objective Response Rate (ORR) From first dosing date up to approximately 67 months ORR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR).
CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.Progression Free Survival (PFS) From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months) PFS is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Trial Locations
- Locations (136)
Local Institution - 0170
🇺🇸Reno, Nevada, United States
Local Institution - 0142
🇺🇸Livingston, New Jersey, United States
Local Institution - 0134
🇺🇸Cleveland, Ohio, United States
Local Institution - 0159
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0001
🇺🇸Sayre, Pennsylvania, United States
Local Institution - 0066
🇺🇸Chattanooga, Tennessee, United States
Local Institution - 0097
🇺🇸Fairfax, Virginia, United States
Local Institution - 0004
🇺🇸Durham, North Carolina, United States
Va San Diego Healthcare System
🇺🇸San Diego, California, United States
Local Institution - 0146
🇺🇸Bakersfield, California, United States
Local Institution - 0174
🇺🇸Renton, Washington, United States
Local Institution - 0086
🇺🇸Waco, Texas, United States
Local Institution - 0026
🇩🇪Loewenstein, Germany
Local Institution - 0054
🇮🇹Milan, Lombardia, Italy
Local Institution - 0152
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0089
🇺🇸Edina, Minnesota, United States
Local Institution - 0141
🇺🇸Grand Junction, Colorado, United States
Local Institution - 0108
🇺🇸Wichita, Kansas, United States
Local Institution - 0067
🇺🇸Nashville, Tennessee, United States
Local Institution - 0121
🇺🇸Birmingham, Alabama, United States
Local Institution - 0083
🇺🇸Denver, Colorado, United States
Local Institution - 0176
🇺🇸Portland, Oregon, United States
Local Institution - 0147
🇺🇸Pembroke Pines, Florida, United States
Cancer Specialists of North FL
🇺🇸Jacksonville, Florida, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
Local Institution - 0009
🇦🇷Cordoba, Argentina
Local Institution - 0069
🇫🇷Marseille Cedex 20, France
Local Institution - 0087
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0036
🇧🇪Sint-Niklaas, Belgium
Local Institution - 0109
🇨🇦Montreal, Quebec, Canada
Local Institution - 0096
🇺🇸Eugene, Oregon, United States
Local Institution - 0050
🇨🇦Trois-Rivieres, Quebec, Canada
Local Institution - 0148
🇺🇸Phoenix, Arizona, United States
Local Institution - 0164
🇺🇸Little Rock, Arkansas, United States
Local Institution - 0126
🇦🇷Tucuman, Argentina
Local Institution - 0073
🇫🇷Toulon Cedex, France
Local Institution - 0008
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0007
🇦🇷Caba, Argentina
Local Institution - 0118
🇫🇷Bordeaux, France
Local Institution - 0071
🇫🇷Rennes Cedex 9, France
Local Institution - 0029
🇩🇪Kassel, Germany
Local Institution - 0025
🇩🇪Wiesbaden, Germany
Local Institution - 0032
🇬🇷Thessaloniki, Greece
Local Institution - 0010
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0075
🇫🇷Dijon Cedex, France
Local Institution - 0023
🇩🇪Frankfurt, Germany
Local Institution - 0019
🇲🇽Monterrey, NL, Mexico
Local Institution - 0119
🇷🇴Craiova, Romania
Local Institution - 0120
🇷🇴Romania, Romania
Local Institution - 0039
🇬🇧Leicester, Leicestershire, United Kingdom
Local Institution - 0074
🇫🇷Pessac cedex, France
Local Institution - 0028
🇩🇪Gera, Germany
Local Institution - 0030
🇬🇷Athens, Greece
Local Institution - 0013
🇭🇺Gyöngyös - Mátraháza, Heves, Hungary
IRST Meldola
🇮🇹Meldola, Italy
AOU della Campania Luigi Vanvitelli
🇮🇹Napoli, Italy
Ospedale Degli Infermi
🇮🇹Rimini, Italy
Local Institution - 0015
🇵🇱Bydgoszcz, Poland
Local Institution - 0104
🇹🇷Antalya, Turkey
Local Institution - 0040
🇬🇧Edinburgh, Midlothian, United Kingdom
Local Institution - 0022
🇷🇺Moscow, Russian Federation
Local Institution
🇮🇹Napoli, Italy
Azienda Ospedaliera Santa Maria Terni
🇮🇹Terni, Italy
Local Institution - 0035
🇳🇱Rotterdam, Netherlands
Local Institution - 0016
🇵🇱Warszawa, Poland
Local Institution - 0020
🇷🇺St Petersburg, Russian Federation
Local Institution - 0014
🇭🇺Budapest, Hungary
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Local Institution - 0128
🇷🇴Bucuresti, Romania
Local Institution - 0021
🇷🇺Moscow, Russian Federation
Local Institution - 0012
🇺🇸Winston-Salem, North Carolina, United States
Local Institution - 0085
🇺🇸Tucson, Arizona, United States
Marin Cancer Care, Inc
🇺🇸Greenbrae, California, United States
Torrance Health Association
🇺🇸Redondo Beach, California, United States
Local Institution - 0115
🇺🇸Los Angeles, California, United States
Los Angeles Hematology/Oncology Medical Group
🇺🇸Los Angeles, California, United States
Local Institution - 0143
🇺🇸San Luis Obispo, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
🇺🇸Truckee, California, United States
Local Institution - 0144
🇺🇸Santa Maria, California, United States
Local Institution - 0161
🇺🇸Whittier, California, United States
Local Institution - 0002
🇺🇸Atlanta, Georgia, United States
Local Institution - 0166
🇺🇸Atlanta, Georgia, United States
Local Institution - 0163
🇺🇸Athens, Georgia, United States
Local Institution - 0088
🇺🇸Niles, Illinois, United States
Kentucky One Health St. Joseph East Cancer Center
🇺🇸Lexington, Kentucky, United States
Local Institution - 0091
🇺🇸Columbia, Maryland, United States
Jackson Oncology Associates, Pllc
🇺🇸Jackson, Mississippi, United States
Local Institution - 0077
🇺🇸Grand Island, Nebraska, United States
Local Institution - 0156
🇺🇸Belleville, New Jersey, United States
Local Institution - 0100
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0172
🇺🇸Corvallis, Oregon, United States
Local Institution - 0139
🇺🇸Allentown, Pennsylvania, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Oncology, P.A.
🇺🇸Dallas, Texas, United States
Local Institution - 0094
🇺🇸Fort Worth, Texas, United States
Local Institution - 0149
🇺🇸Dallas, Texas, United States
Local Institution - 0098
🇺🇸Plano, Texas, United States
Local Institution - 0093
🇺🇸Longview, Texas, United States
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
Local Institution - 0173
🇺🇸Spokane, Washington, United States
Local Institution - 0006
🇦🇷Viedma, RIO Negro, Argentina
Local Institution - 0037
🇧🇪Liege, Belgium
Local Institution - 0038
🇧🇪Gent, Belgium
Local Institution - 0153
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0151
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0154
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0049
🇨🇦Rimouski, Quebec, Canada
Local Institution - 0127
🇨🇦Greenfield Park, Quebec, Canada
Local Institution - 0011
🇨🇱Santiago, Chile
Local Institution - 0133
🇨🇿Novy Jicin, Czechia
Local Institution - 0130
🇨🇿Praha 2, Czechia
Local Institution - 0076
🇫🇷Paris, France
Local Institution - 0070
🇫🇷Saint Herblain, France
Local Institution - 0072
🇫🇷Strasbourg Cedex, France
Local Institution - 0031
🇬🇷N. Faliro, Greece
Local Institution - 0060
🇪🇸Barcelona, Spain
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Local Institution - 0045
🇳🇱Groningen, Netherlands
Local Institution - 0068
🇵🇱Sucha Beskidzka, Poland
Local Institution - 0061
🇪🇸A Coruña, Spain
Local Institution - 0065
🇪🇸Madrid, Spain
Local Institution - 0062
🇪🇸Jaen, Spain
Local Institution - 0064
🇪🇸Majadahonda - Madrid, Spain
Local Institution - 0059
🇪🇸Valencia, Spain
Local Institution - 0112
🇪🇸Zaragoza, Spain
Local Institution - 0063
🇪🇸Sevilla, Spain
Local Institution - 0048
🇨🇭Basel, Switzerland
Local Institution - 0046
🇨🇭Zuerich, Switzerland
Local Institution - 0041
🇬🇧London, Greater London, United Kingdom
Local Institution - 0043
🇬🇧Newcastle Upon Tyne, United Kingdom
Local Institution - 0042
🇬🇧Wirral, United Kingdom
Local Institution - 0167
🇺🇸Bronx, New York, United States
Local Institution - 0123
🇺🇸Charleston, South Carolina, United States
Local Institution - 0090
🇺🇸Austin, Texas, United States
Local Institution - 0044
🇺🇸Richmond, Virginia, United States
Local Institution - 0082
🇺🇸Ocala, Florida, United States