An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

NCT02869789 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CA209-8172016-002621-10
• Study Type: interventional
• Target: 1,041
• Locations: 21 countries
• Sites: 136

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)

  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

  From first dose to 30 days post last dose (Up to approximately 27 months)

• Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)

  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= Death

  From first dose to 100 days post last dose (Up to approximately 29 months)

Secondary Outcomes (5)

• 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)

• Overall Survival (OS)

  From first dosing date to the date of death (Up to approximately 67 months)

• Objective Response Rate (ORR)

  From first dosing date up to approximately 67 months

• 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)

• 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)

Study Arms (1)

Nivolumab in combination with Ipilimumab

EXPERIMENTAL

Specified dose on specified days

Drug: Nivolumab in combination with Ipilimumab

Interventions

Nivolumab in combination with Ipilimumab DRUG

Specified dose on specified days

Also known as: BMS-936558 (Nivolumab), Opdivo (Nivolumab), BMS-734016 (Ipilimumab), Yervoy (Ipilimumab)

Nivolumab in combination with Ipilimumab

Eligibility Criteria

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

You may qualify if:

• 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
• 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
• High Tumor Mutation Burden

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (136)

Local Institution - 0121

Birmingham, Alabama, 35205, United States

Location

Local Institution - 0148

Phoenix, Arizona, 85016, United States

Location

Local Institution - 0085

Tucson, Arizona, 85704, United States

Location

Local Institution - 0164

Little Rock, Arkansas, 72205, United States

Location

Local Institution - 0146

Bakersfield, California, 93309, United States

Location

Marin Cancer Care, Inc

Greenbrae, California, 94904, United States

Location

Los Angeles Hematology/Oncology Medical Group

Los Angeles, California, 90017, United States

Location

Local Institution - 0115

Los Angeles, California, 90095, United States

Location

Torrance Health Association

Redondo Beach, California, 90277, United States

Location

Va San Diego Healthcare System

San Diego, California, 92161, United States

Location

Local Institution - 0143

San Luis Obispo, California, 93401, United States

Location

Local Institution - 0144

Santa Maria, California, 93454, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Local Institution - 0161

Whittier, California, 90603, United States

Location

Local Institution - 0083

Denver, Colorado, 80218, United States

Location

Local Institution - 0141

Grand Junction, Colorado, 81501, United States

Location

Cancer Specialists of North FL

Jacksonville, Florida, 32207, United States

Location

Local Institution - 0082

Ocala, Florida, 34474, United States

Location

Local Institution - 0147

Pembroke Pines, Florida, 33028, United States

Location

Local Institution - 0163

Athens, Georgia, 30607, United States

Location

Local Institution - 0002

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0166

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0088

Niles, Illinois, 60714, United States

Location

Local Institution - 0108

Wichita, Kansas, 67214, United States

Location

Kentucky One Health St. Joseph East Cancer Center

Lexington, Kentucky, 40509, United States

Location

Local Institution - 0091

Columbia, Maryland, 21044, United States

Location

Local Institution - 0089

Edina, Minnesota, 55435-2150, United States

Location

Jackson Oncology Associates, Pllc

Jackson, Mississippi, 39202, United States

Location

Local Institution - 0077

Grand Island, Nebraska, 68803, United States

Location

Local Institution - 0087

Las Vegas, Nevada, 89148, United States

Location

Local Institution - 0170

Reno, Nevada, 89511, United States

Location

Local Institution - 0156

Belleville, New Jersey, 07109, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932, United States

Location

Local Institution - 0142

Livingston, New Jersey, 07039, United States

Location

Local Institution - 0167

The Bronx, New York, 10461, United States

Location

Local Institution - 0004

Durham, North Carolina, 27710, United States

Location

Local Institution - 0012

Winston-Salem, North Carolina, 27157, United States

Location

Local Institution - 0100

Cincinnati, Ohio, 45242, United States

Location

Local Institution - 0134

Cleveland, Ohio, 44109, United States

Location

Local Institution - 0172

Corvallis, Oregon, 97330, United States

Location

Local Institution - 0096

Eugene, Oregon, 97401, United States

Location

Local Institution - 0176

Portland, Oregon, 97239, United States

Location

Local Institution - 0139

Allentown, Pennsylvania, 18103, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution - 0159

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0001

Sayre, Pennsylvania, 18840, United States

Location

Local Institution - 0123

Charleston, South Carolina, 29414, United States

Location

Local Institution - 0066

Chattanooga, Tennessee, 37404, United States

Location

Local Institution - 0067

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0090

Austin, Texas, 78745, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75230, United States

Location

Local Institution - 0149

Dallas, Texas, 75231, United States

Location

Local Institution - 0094

Fort Worth, Texas, 76104, United States

Location

Local Institution - 0093

Longview, Texas, 75601, United States

Location

Local Institution - 0098

Plano, Texas, 75075-7787, United States

Location

Local Institution - 0086

Waco, Texas, 76712, United States

Location

Local Institution - 0097

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0044

Richmond, Virginia, 23230, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Local Institution - 0174

Renton, Washington, 98055, United States

Location

Local Institution - 0173

Spokane, Washington, 99208, United States

Location

Local Institution - 0008

Capital Federal, Buenos Aires, 1426, Argentina

Location

Local Institution - 0006

Viedma, Río Negro Province, 8500, Argentina

Location

Local Institution - 0007

CABA, 1199, Argentina

Location

Local Institution - 0009

Córdoba, 5000, Argentina

Location

Local Institution - 0126

San Miguel de Tucumán, 4000, Argentina

Location

Local Institution - 0038

Ghent, 9000, Belgium

Location

Local Institution - 0037

Liège, 4000, Belgium

Location

Local Institution - 0036

Sint-Niklaas, 9100, Belgium

Location

Local Institution - 0152

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0154

Porto Alegre, Rio Grande do Sul, 90610000, Brazil

Location

Local Institution - 0153

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Local Institution - 0151

Barretos, São Paulo, 14780-070, Brazil

Location

Local Institution - 0127

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Local Institution - 0109

Montreal, Quebec, H4J 1C5, Canada

Location

Local Institution - 0049

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution - 0050

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Local Institution - 0010

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0011

Santiago, Chile

Location

Local Institution - 0133

Nový Jičín, 741 01, Czechia

Location

Local Institution - 0130

Prague, 128 08, Czechia

Location

Local Institution - 0118

Bordeaux, 33076, France

Location

Local Institution - 0075

Dijon, 21079, France

Location

Local Institution - 0069

Marseille, 13915, France

Location

Local Institution - 0076

Paris, 75018, France

Location

Local Institution - 0074

Pessac, 33604, France

Location

Local Institution - 0071

Rennes, 35033, France

Location

Local Institution - 0070

Saint-Herblain, 44805, France

Location

Local Institution - 0072

Strasbourg, 67091, France

Location

Local Institution - 0073

Toulon, 83056, France

Location

Local Institution - 0023

Frankfurt, 60488, Germany

Location

Local Institution - 0028

Gera, 07548, Germany

Location

Local Institution - 0029

Kassel, 34125, Germany

Location

Local Institution - 0026

Löwenstein, 74245, Germany

Location

Local Institution - 0025

Wiesbaden, 65199, Germany

Location

Local Institution - 0030

Athens, 11527, Greece

Location

Local Institution - 0031

N. Faliro, 18547, Greece

Location

Local Institution - 0032

Thessaloniki, 56429, Greece

Location

Local Institution - 0013

Gyöngyös - Mátraháza, Heves County, 3233, Hungary

Location

Local Institution - 0014

Budapest, 1083, Hungary

Location

Local Institution - 0054

Milan, Lombardy, 20141, Italy

Location

Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

IRST Meldola

Meldola, 47014, Italy

Location

AOU della Campania Luigi Vanvitelli

Napoli, 80131, Italy

Location

Local Institution

Napoli, 80131, Italy

Location

Ospedale Degli Infermi

Rimini, 47923, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Azienda Ospedaliera Santa Maria Terni

Terni, 05100, Italy

Location

Local Institution - 0019

Monterrey, NL, 64060, Mexico

Location

Local Institution - 0045

Groningen, 9714 CZ, Netherlands

Location

Local Institution - 0035

Rotterdam, 3014 GD, Netherlands

Location

Local Institution - 0015

Bydgoszcz, 85-796, Poland

Location

Local Institution - 0068

Sucha Beskidzka, 34-200, Poland

Location

Local Institution - 0016

Warsaw, 02-781, Poland

Location

Local Institution - 0128

Bucharest, 021389, Romania

Location

Local Institution - 0119

Craiova, 200347, Romania

Location

Local Institution - 0120

Romania, 400015, Romania

Location

Local Institution - 0022

Moscow, 115478, Russia

Location

Local Institution - 0021

Moscow, 121309, Russia

Location

Local Institution - 0020

Saint Petersburg, 198255, Russia

Location

Local Institution - 0061

A Coruña, 15006, Spain

Location

Local Institution - 0060

Barcelona, 08035, Spain

Location

Local Institution - 0062

Jaén, 23007, Spain

Location

Local Institution - 0065

Madrid, 28041, Spain

Location

Local Institution - 0064

Majadahonda - Madrid, 28222, Spain

Location

Local Institution - 0063

Seville, 41013, Spain

Location

Local Institution - 0059

Valencia, 46026, Spain

Location

Local Institution - 0112

Zaragoza, 50009, Spain

Location

Local Institution - 0048

Basel, 4031, Switzerland

Location

Local Institution - 0046

Zurich, 8091, Switzerland

Location

Local Institution - 0104

Antalya, 07070, Turkey (Türkiye)

Location

Local Institution - 0041

London, Greater London, SE1 9RT, United Kingdom

Location

Local Institution - 0039

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Local Institution - 0040

Edinburgh, Midlothian, EH4 2XU, United Kingdom

Location

Local Institution - 0042

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Local Institution - 0043

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• Ready NE, Audigier-Valette C, Goldman JW, Felip E, Ciuleanu TE, Rosario Garcia Campelo M, Jao K, Barlesi F, Bordenave S, Rijavec E, Urban L, Aucoin JS, Zannori C, Vermaelen K, Aren Frontera O, Curioni Fontecedro A, Sanchez-Gastaldo A, Juan-Vidal O, Linardou H, Poddubskaya E, Spigel DR, Ahmed S, Maio M, Li S, Chang H, Fiore J, Acevedo A, Paz-Ares L. First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817. J Immunother Cancer. 2023 Feb;11(2):e006127. doi: 10.1136/jitc-2022-006127.

  PMID: 36725084 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: October 5, 2016
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-06

Locations

RO (3); ES (8); ME (1); CL (2); GR (3); DE (5); AR (5); FR (9); US (61); RU (3); BE (3); CZ (2); BR (4); CH (2); IT (8); PL (3); TU (1); GB (5); NL (2); HU (2); CA (4)