Advanced CancerPhase 2FRACTION-LungNCT02750514
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Nivolumab, Dasatinib and Relatlimab in people with Advanced Cancer, run by Bristol-Myers Squibb at 50 sites in 8 countries.
Trial summary
The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Nivolumab, Dasatinib and Relatlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 50 sitesin 8 countries
- Study dates
- 9 May 2016to 29 Jan 2020
- Phase
- Phase 2
- 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
- Advanced Non Small Cell Lung Cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
- Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
- Must have at least 1 lesion with measurable disease
Who cannot join
- Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
- Subjects who need daily oxygen therapy
- People with autoimmune disease
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
50 sites in 8 countries.
50 sites in 8 countries
United States35 sites
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce
Ann Arbor, Michigan, 48109
University of Colorado Denver
Aurora, Colorado, 80045
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Univ of NC Shool of Medicine
Chapel Hill, North Carolina, 27514
The Ohio State University
Columbus, Ohio, 43210
Sammons Cancer Center (Uso)
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Texas Oncology, P.A.
Fort Worth, Texas, 76104
The West Clinic, P.C. d/b/a West Cancer Center
Germantown, Tennessee, 38138
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89119
University of Southern California (USC)
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Californa, Los Angeles (UCLA)
Los Angeles, California, 90095
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06511
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15217
Northwest Cancer Specialists
Portland, Oregon, 97225
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of California San Diego
San Diego, California, 92122
University of Washington-Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University, The Center for Advanced Medicine
St Louis, Missouri, 63110
Us Oncology
Tyler, Texas, 75702
University of Kansas Cancer Center
Westwood, Kansas, 66205
Canada3 sites
Local Institution
Edmonton, T6G 1Z2
Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences
Hamilton, Ontario, L8V 5C2
University Of Ottawa - The Ottawa Hospital Cancer centre
Ottawa, Ontario, K1H 8L6
France3 sites
Local Institution
Paris, 75005
Local Institution
Toulouse, 31059
Local Institution
Villejuif, 94805
Italy3 sites
Local Institution
Milan, 20141
Local Institution
Milan, 20132
Local Institution
Rozzano, 20089
Spain3 sites
Local Institution
Madrid, 28041
Local Institution
Madrid, 28050
Local Institution
Pamplona, 31008
About this study
Official title: A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)
The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer
- Conditions
- Advanced Cancer
- Being tested
- Nivolumab, Dasatinib, Relatlimab, Ipilimumab, BMS-986205
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558, MDX-1106, OPDIVO
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
DasatinibDrug
Also called BMS-354825, SPRYCEL
RelatlimabBiological
Also called BMS-986016
IpilimumabBiological
Also called BMS-734016, Yervoy
BMS-986205Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Active comparator | Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator Receives: Biological: Nivolumab |
| Nivolumab & Dasatinib | Experimental | Nivolumab in combination with Dasatinib Receives: Biological: Nivolumab; Drug: Dasatinib |
| Nivolumab & Relatlimab | Experimental | Nivolumab in combination with Relatlimab Receives: Biological: Nivolumab; Biological: Relatlimab |
| Nivolumab & Ipilimumab | Experimental | Nivolumab in combination with Ipilimumab Receives: Biological: Nivolumab; Biological: Ipilimumab |
| Nivolumab & BMS-986205 | Experimental | Nivolumab in combination with BMS- 986205 Receives: Biological: Nivolumab; Drug: BMS-986205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Measured: From first dose to 2 years following last dose (up to 30 months)
Duration of Response (DOR)
DOR, computed for all treated participants with a confirmed BOR of CR or PR, is defined as the time between the date of first response and the date of first documented disease progression (as determined by RECIST 1.1) or death due to any cause.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Measured: From first dose to 2 years following last dose (up to 30 months)
Progression Free Survival Rate (PFSR) at 24 Weeks
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Measured: From first dose to 24 weeks after first dose
Secondary outcomes (6)
Percentage of Participants Experiencing Adverse Events (AEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame
Measured: From first dose to 100 days following last dose
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame
Measured: From first dose to 100 days following last dose
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame
Measured: From first dose to 100 days following last dose
Percentage of Participants Experiencing Death
This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame
Measured: From first dose to up to 45 months following first dose
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
The following measurements will be considered laboratory abnormalities for hepatic tests:
- ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
- Total bilirubin > 2 x ULN
- Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
- Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal
Measured: From first dose to 100 days following last dose (approximately 9 months)
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
The following measurements will be considered laboratory abnormalities for thyroid tests:
- TSH value > ULN and
- With baseline TSH value ≤ ULN
- At least one T3/T4 test value < LLN
- Low TSH < LLN and
- With baseline TSH value ≥ LLN
- At least one T3/T4 test value > ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine
Measured: From first dose to 100 days following last dose (approximately 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start9 May 2016
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
Why it stopped: The standard of care for the patient population changed and we were unable to accrue any longer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 295 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
- NCT02750514
- Sponsor's protocol ID
- CA018-001
- Acronym
- FRACTION-Lung
- Status last verified
- Feb 2021
- First submitted
- 21 Apr 2016
- Last updated
- 22 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)
- ClinicalTrials.gov ID
- NCT02750514
- Acronym / sponsor ID
- FRACTION-Lung / CA018-001
- Conditions
- Advanced Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The standard of care for the patient population changed and we were unable to accrue any longer.
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 May 2016 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 22 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Active comparator | Biological: NivolumabNivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator |
| Nivolumab & Dasatinib | Experimental | Biological: Nivolumab, Drug: DasatinibNivolumab in combination with Dasatinib |
| Nivolumab & Relatlimab | Experimental | Biological: Nivolumab, Biological: RelatlimabNivolumab in combination with Relatlimab |
| Nivolumab & Ipilimumab | Experimental | Biological: Nivolumab, Biological: IpilimumabNivolumab in combination with Ipilimumab |
| Nivolumab & BMS-986205 | Experimental | Biological: Nivolumab, Drug: BMS-986205Nivolumab in combination with BMS- 986205 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced Non Small Cell Lung Cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
- Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
- Must have at least 1 lesion with measurable disease
Key exclusion criteria (4 listed)
- Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
- Subjects who need daily oxygen therapy
- People with autoimmune disease
- 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, MDX-1106, OPDIVOArm associated with this intervention is closed. Nivolumab is no longer given as an active comparator. | Biological | Nivolumab, Nivolumab & BMS-986205, Nivolumab & Dasatinib, Nivolumab & Ipilimumab, Nivolumab & Relatlimab |
| DasatinibAlso: BMS-354825, SPRYCEL | Drug | Nivolumab & Dasatinib |
| RelatlimabAlso: BMS-986016 | Biological | Nivolumab & Relatlimab |
| IpilimumabAlso: BMS-734016, Yervoy | Biological | Nivolumab & Ipilimumab |
| BMS-986205Specified dose on specified days | Drug | Nivolumab & BMS-986205 |
Primary outcome
Objective Response Rate (ORR)
Time frame: From first dose to 2 years following last dose (up to 30 months)
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Duration of Response (DOR)
Time frame: From first dose to 2 years following last dose (up to 30 months)
DOR, computed for all treated participants with a confirmed BOR of CR or PR, is defined as the time between the date of first response and the date of first documented disease progression (as determined by RECIST 1.1) or death due to any cause. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Progression Free Survival Rate (PFSR) at 24 Weeks
Time frame: From first dose to 24 weeks after first dose
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
6 secondary outcomes
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: From first dose to 100 days following last dose
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: From first dose to 100 days following last dose
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Time frame: From first dose to 100 days following last dose
Percentage of Participants Experiencing Death
Time frame: From first dose to up to 45 months following first dose
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
Time frame: From first dose to 100 days following last dose (approximately 9 months)
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
Time frame: From first dose to 100 days following last dose (approximately 9 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
50 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Dasatinib and Relatlimab in people with Advanced Cancer, run by Bristol-Myers Squibb at 50 sites in 8 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada, France, Italy, Spain and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 22 Mar 2021). 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?
Objective Response Rate (ORR) (time frame: From first dose to 2 years following last dose (up to 30 months)). The study lists 3 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 22 Mar 2021.