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Lung CancerPhase 4NCT02869789

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

A Phase 4 study testing Nivolumab in combination with Ipilimumab in people with Lung Cancer, run by Bristol-Myers Squibb at 136 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Nivolumab in combination with Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,041 participants
Where
136 sitesin 21 countries
Study dates
5 Oct 2016to 13 May 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

136 sites in 21 countries.

136 sites in 21 countries

United States61 sites

  • Local Institution - 0139

    Allentown, Pennsylvania, 18103

  • Local Institution - 0163

    Athens, Georgia, 30607

  • Local Institution - 0002

    Atlanta, Georgia, 30322

  • Local Institution - 0166

    Atlanta, Georgia, 30342

  • Local Institution - 0090

    Austin, Texas, 78745

  • Local Institution - 0146

    Bakersfield, California, 93309

  • Local Institution - 0156

    Belleville, New Jersey, 07109

  • Local Institution - 0121

    Birmingham, Alabama, 35205

  • Local Institution - 0123

    Charleston, South Carolina, 29414

  • Local Institution - 0066

    Chattanooga, Tennessee, 37404

  • Local Institution - 0100

    Cincinnati, Ohio, 45242

  • Local Institution - 0134

    Cleveland, Ohio, 44109

  • Local Institution - 0091

    Columbia, Maryland, 21044

  • Local Institution - 0172

    Corvallis, Oregon, 97330

  • Texas Oncology, P.A.

    Dallas, Texas, 75230

  • Local Institution - 0149

    Dallas, Texas, 75231

  • Local Institution - 0083

    Denver, Colorado, 80218

  • Local Institution - 0004

    Durham, North Carolina, 27710

  • Local Institution - 0089

    Edina, Minnesota, 55435-2150

  • Local Institution - 0096

    Eugene, Oregon, 97401

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Local Institution - 0097

    Fairfax, Virginia, 22031

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • Local Institution - 0094

    Fort Worth, Texas, 76104

  • Local Institution - 0077

    Grand Island, Nebraska, 68803

  • Local Institution - 0141

    Grand Junction, Colorado, 81501

  • Marin Cancer Care, Inc

    Greenbrae, California, 94904

  • Jackson Oncology Associates, Pllc

    Jackson, Mississippi, 39202

  • Cancer Specialists of North FL

    Jacksonville, Florida, 32207

  • Local Institution - 0087

    Las Vegas, Nevada, 89148

  • Kentucky One Health St. Joseph East Cancer Center

    Lexington, Kentucky, 40509

  • Local Institution - 0164

    Little Rock, Arkansas, 72205

  • Local Institution - 0142

    Livingston, New Jersey, 07039

  • Local Institution - 0093

    Longview, Texas, 75601

  • Los Angeles Hematology/Oncology Medical Group

    Los Angeles, California, 90017

  • Local Institution - 0115

    Los Angeles, California, 90095

  • Local Institution - 0067

    Nashville, Tennessee, 37203

  • Local Institution - 0088

    Niles, Illinois, 60714

  • Local Institution - 0082

    Ocala, Florida, 34474

  • Local Institution - 0147

    Pembroke Pines, Florida, 33028

  • Local Institution - 0148

    Phoenix, Arizona, 85016

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

  • Local Institution - 0159

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0098

    Plano, Texas, 75075-7787

  • Local Institution - 0176

    Portland, Oregon, 97239

  • Torrance Health Association

    Redondo Beach, California, 90277

  • Local Institution - 0170

    Reno, Nevada, 89511

  • Local Institution - 0174

    Renton, Washington, 98055

  • Local Institution - 0044

    Richmond, Virginia, 23230

  • Va San Diego Healthcare System

    San Diego, California, 92161

  • Local Institution - 0143

    San Luis Obispo, California, 93401

  • Local Institution - 0144

    Santa Maria, California, 93454

  • Local Institution - 0001

    Sayre, Pennsylvania, 18840

  • Local Institution - 0173

    Spokane, Washington, 99208

  • Local Institution - 0167

    The Bronx, New York, 10461

  • Gene Upshaw Memorial Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Local Institution - 0085

    Tucson, Arizona, 85704

  • Local Institution - 0086

    Waco, Texas, 76712

  • Local Institution - 0161

    Whittier, California, 90603

  • Local Institution - 0108

    Wichita, Kansas, 67214

  • Local Institution - 0012

    Winston-Salem, North Carolina, 27157

Other trials in United States

France9 sites

  • Local Institution - 0118

    Bordeaux, 33076

  • Local Institution - 0075

    Dijon, 21079

  • Local Institution - 0069

    Marseille, 13915

  • Local Institution - 0076

    Paris, 75018

  • Local Institution - 0074

    Pessac, 33604

  • Local Institution - 0071

    Rennes, 35033

  • Local Institution - 0070

    Saint-Herblain, 44805

  • Local Institution - 0072

    Strasbourg, 67091

  • Local Institution - 0073

    Toulon, 83056

Other trials in France

Italy8 sites

  • Ospedale Policlinico San Martino

    Genova, 16132

  • IRST Meldola

    Meldola, 47014

  • Local Institution - 0054

    Milan, Lombardy, 20141

  • AOU della Campania Luigi Vanvitelli

    Naples, 80131

  • Local Institution

    Naples, 80131

  • Ospedale Degli Infermi

    Rimini, 47923

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100

Other trials in Italy

Spain8 sites

  • Local Institution - 0061

    A Coruña, 15006

  • Local Institution - 0060

    Barcelona, 08035

  • Local Institution - 0062

    Jaén, 23007

  • Local Institution - 0065

    Madrid, 28041

  • Local Institution - 0064

    Majadahonda - Madrid, 28222

  • Local Institution - 0063

    Seville, 41013

  • Local Institution - 0059

    Valencia, 46026

  • Local Institution - 0112

    Zaragoza, 50009

Other trials in Spain

Argentina5 sites

  • Local Institution - 0007

    CABA, 1199

  • Local Institution - 0008

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0009

    Córdoba, 5000

  • Local Institution - 0126

    San Miguel de Tucumán, 4000

  • Local Institution - 0006

    Viedma, Río Negro Province, 8500

Other trials in Argentina

Germany5 sites

  • Local Institution - 0023

    Frankfurt, 60488

  • Local Institution - 0028

    Gera, 07548

  • Local Institution - 0029

    Kassel, 34125

  • Local Institution - 0026

    Löwenstein, 74245

  • Local Institution - 0025

    Wiesbaden, 65199

Other trials in Germany

United Kingdom5 sites

  • Local Institution - 0040

    Edinburgh, Midlothian, EH4 2XU

  • Local Institution - 0039

    Leicester, Leicestershire, LE1 5WW

  • Local Institution - 0041

    London, Greater London, SE1 9RT

  • Local Institution - 0042

    Metropolitan Borough of Wirral, CH63 4JY

  • Local Institution - 0043

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Brazil4 sites

  • Local Institution - 0151

    Barretos, São Paulo, 14780-070

  • Local Institution - 0152

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0154

    Porto Alegre, Rio Grande do Sul, 90610000

  • Local Institution - 0153

    Porto Alegre, Rio Grande do Sul, 91350-200

Other trials in Brazil

Canada4 sites

  • Local Institution - 0127

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution - 0109

    Montreal, Quebec, H4J 1C5

  • Local Institution - 0049

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0050

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Belgium3 sites

  • Local Institution - 0038

    Ghent, 9000

  • Local Institution - 0037

    Liège, 4000

  • Local Institution - 0036

    Sint-Niklaas, 9100

Other trials in Belgium

Greece3 sites

  • Local Institution - 0030

    Athens, 11527

  • Local Institution - 0031

    N. Faliro, 18547

  • Local Institution - 0032

    Thessaloniki, 56429

Other trials in Greece

Poland3 sites

  • Local Institution - 0015

    Bydgoszcz, 85-796

  • Local Institution - 0068

    Sucha Beskidzka, 34-200

  • Local Institution - 0016

    Warsaw, 02-781

Other trials in Poland

Romania3 sites

  • Local Institution - 0128

    Bucharest, 021389

  • Local Institution - 0119

    Craiova, 200347

  • Local Institution - 0120

    Romania, 400015

Other trials in Romania

Russia3 sites

  • Local Institution - 0022

    Moscow, 115478

  • Local Institution - 0021

    Moscow, 121309

  • Local Institution - 0020

    Saint Petersburg, 198255

Other trials in Russia

Chile2 sites

  • Local Institution - 0010

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0011

    Santiago

Other trials in Chile

Czechia2 sites

  • Local Institution - 0133

    Nový Jičín, 741 01

  • Local Institution - 0130

    Prague, 128 08

Other trials in Czechia

Hungary2 sites

  • Local Institution - 0014

    Budapest, 1083

  • Local Institution - 0013

    Gyöngyös - Mátraháza, Heves County, 3233

Other trials in Hungary

Netherlands2 sites

  • Local Institution - 0045

    Groningen, 9714 CZ

  • Local Institution - 0035

    Rotterdam, 3014 GD

Other trials in Netherlands

Switzerland2 sites

  • Local Institution - 0048

    Basel, 4031

  • Local Institution - 0046

    Zurich, 8091

Other trials in Switzerland

Mexico1 site

  • Local Institution - 0019

    Monterrey, NL, 64060

Other trials in Mexico

Turkey (Türkiye)1 site

  • Local Institution - 0104

    Antalya, 07070

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer

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
Being tested
Nivolumab in combination with Ipilimumab
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab in combination with IpilimumabDrug

    Also called BMS-936558 (Nivolumab), Opdivo (Nivolumab), BMS-734016 (Ipilimumab), Yervoy (Ipilimumab)

    Specified dose on specified days

Study groups in NCT02869789
Study groupRoleWhat they receive
Nivolumab in combination with IpilimumabExperimentalSpecified dose on specified days
Receives: Drug: Nivolumab in combination with Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    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.

    Measured: 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)

  2. Overall Survival (OS)

    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.

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

  3. Objective Response Rate (ORR)

    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.

    Measured: From first dosing date up to approximately 67 months

  4. Duration of Response (DoR)

    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.

    Measured: 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)

  5. Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)

    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.

    Measured: From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2016 (estimated)
  2. Study start5 Oct 2016
  3. Primary completion13 May 2022
  4. Study completion13 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,041 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02869789
Sponsor's protocol ID
CA209-817
Other IDs
2016-002621-10, 2016
Status last verified
Jun 2023
First submitted
12 Aug 2016
Last updated
15 Jun 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36725084

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nivolumab in combination with Ipilimumab in people with Lung Cancer, run by Bristol-Myers Squibb at 136 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, France, Italy, Spain, Argentina and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) (time frame: From first dose to 30 days post last dose (Up to approximately 27 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02869789, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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