Non-Small Cell Lung CancerPhase 3CheckMate 955NCT03048136
A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
A Phase 3 study testing Nivolumab and Ipilimumab in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 17 sites in 5 countries.
Trial summary
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 9 Mar 2018to 29 Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 1) Stage IV or recurrent non-Small cell lung cancer
- 2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- 3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
Who cannot join
- 1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
- 2) Active, known or suspected autoimmune disease or HIV infection
- 3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
- 4) Untreated Central Nervous System metastases
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States9 sites
Local Institution
Charleston, South Carolina, 29414
Local Institution
Columbus, Ohio, 43210
Local Institution
Hackensack, New Jersey, 07601
Local Institution
Lancaster, Pennsylvania, 17604
Local Institution
Langhorne, Pennsylvania, 19047
Local Institution
Lincoln, Nebraska, 68506
Local Institution
San Francisco, California, 94115
Local Institution
Sayre, Pennsylvania, 18840
Local Institution
St. George, Utah, 84770
Germany4 sites
Local Institution
Dresden, 01307
Local Institution
Gauting, 82131
Local Institution
Gerlingen, 70839
Local Institution
Großhansdorf, 22927
About this study
Official title: A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
Read the detailed description
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Nivolumab, Ipilimumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-936558, Opdivo
Specified dose on specified days
IpilimumabDrug
Also called BMS-734016, Yervoy
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Flat-Dose | Experimental | Nivolumab flat dose + Ipilimumab Receives: Drug: Nivolumab; Drug: Ipilimumab |
| Weight-Based Dose | Experimental | Nivolumab weight-based dose + Ipilimumab Receives: Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
Measured: Approximately 3 months
Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
Measured: Approximately 3 months
Secondary outcomes (4)
Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: Up to 24 months
Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: Up to 24 months
Overall survival (OS) as defined as the time from first dosing to the date of death
Measured: Up to 5 years
Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start9 Mar 2018 (estimated)
- Primary completion29 Sep 2019 (estimated)
- Study completion29 Sep 2019 (estimated)
Why it stopped: Business objective has changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048136
- Sponsor's protocol ID
- CA209-955
- Acronym
- CheckMate 955
- Status last verified
- Apr 2018
- First submitted
- 8 Feb 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)
- ClinicalTrials.gov ID
- NCT03048136
- Acronym / sponsor ID
- CheckMate 955 / CA209-955
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objective has changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2018 (estimated)
- Primary completion
- 29 Sep 2019 (estimated)
- Study completion
- 29 Sep 2019 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
Detailed description
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flat-Dose | Experimental | Drug: Nivolumab, Drug: IpilimumabNivolumab flat dose + Ipilimumab |
| Weight-Based Dose | Experimental | Drug: Nivolumab, Drug: IpilimumabNivolumab weight-based dose + Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Stage IV or recurrent non-Small cell lung cancer
- 2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- 3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
Key exclusion criteria (5 listed)
- 1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
- 2) Active, known or suspected autoimmune disease or HIV infection
- 3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
- 4) Untreated Central Nervous System metastases
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days | Drug | Flat-Dose, Weight-Based Dose |
| IpilimumabAlso: BMS-734016, YervoySpecified dose on specified days | Drug | Flat-Dose, Weight-Based Dose |
Primary outcome
Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
Time frame: Approximately 3 months
Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
Time frame: Approximately 3 months
4 secondary outcomes
Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 24 months
Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 24 months
Overall survival (OS) as defined as the time from first dosing to the date of death
Time frame: Up to 5 years
Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab and Ipilimumab in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 17 sites in 5 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 3 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: withdrawn, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, Peru, Argentina, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events (time frame: Approximately 3 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?
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 17 Apr 2018.