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Squamous Cell Non-small Cell Lung CancerPhase 2NCT01721759

Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens

A Phase 2 study testing Nivolumab in people with Squamous Cell Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 33 sites in 4 countries.

Completed

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

Official record
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Trial summary

The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Non-small Cell Lung Cancer
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
33 sitesin 4 countries
Study dates
16 Nov 2012to 22 Apr 2021
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

  • Men and women ≥18 years of age
  • Patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation for locally advanced disease
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
  • Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1

Who cannot join

  • Untreated central nervous system (CNS) metastases. Metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of ≤10 mg prednisone daily (or equivalent)
  • Carcinomatous meningitis
  • Active known or suspected autoimmune disease or interstitial lung disease
  • Prior treatment on either arm of study CA209-017 or CA184-104
  • Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
  • A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

United States20 sites

  • Network Office of Research and Innovation

    Allentown, Pennsylvania, 18103

  • Winship Cancer Institute.

    Atlanta, Georgia, 30322

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University Of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27599-7305

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • Oncology Consultants, Pa

    Houston, Texas, 77024

  • Local Institution

    Metairie, Louisiana, 70006

  • Henry-Joyce Cancer Center

    Nashville, Tennessee, 37232

  • Beth Israel Comprehensive Cancer Center

    New York, New York, 10011

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • University Of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Oncology And Hematology

    Portland, Oregon, 97213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University Of California Davis Medical Center

    Sacramento, California, 95817

  • Va San Diego Healthcare System

    San Diego, California, 92161

  • Providence Cancer Institute

    Southfield, Michigan, 48075

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

France7 sites

  • Local Institution

    Caen, 14000

  • Local Institution

    Créteil, 94010

  • Local Institution

    Pierre-Bénite, 69495

  • Local Institution

    Rennes, 35033

  • Local Institution

    Strasbourg, 67090

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Villejuif, 94800

Other trials in France

Germany3 sites

  • Local Institution

    Berlin, 13125

  • Local Institution

    Cologne, 50937

  • Local Institution

    München, 80336

Other trials in Germany

Italy3 sites

  • Local Institution

    Livorno, 57100

  • Local Institution

    Lucca, 55100

  • Local Institution

    Terni, 05100

Other trials in Italy

About this study

Official title: A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens

Being tested
Nivolumab

What participants receive

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

Study groups in NCT01721759
Study groupRoleWhat they receive
Nivolumab, 3 mg/kgExperimentalParticipants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
Receives: Drug: Nivolumab

What is being measured

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

  1. Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)

    ORR is defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.

    The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.

    Measured: Day 1 of treatment up to approximately 14 months

  2. Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC)

    DOR is defined as the time from first confirmed response (CR or PR) per IRC assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.

    Measured: From the first treatment to the date of the first documented tumor progression or death. Approximately up to 14 months

Secondary outcomes (2)

  1. Objective Response Rate (ORR) as Assessed by Investigator

    ORR is defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment.

    The investigator-assessed ORR is summarized by a binomial response rate and its corresponding two-sided 95% exact CIs using Clopper-Pearson method.

    Measured: Day 1 of treatment to approximately 101 months

  2. Duration of Response (DOR) as Assessed by Investigator

    DOR is defined as the time from first confirmed response (CR or PR) per investigator assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.

    Measured: From the first treatment to the date of the first documented tumor progression or death. Approximately up to 101 months

Timeline

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

  1. First posted6 Nov 2012 (estimated)
  2. Study start16 Nov 2012
  3. Primary completion22 Jan 2014
  4. Study completion22 Apr 2021

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01721759
Sponsor's protocol ID
CA209-063
Other IDs
2012-003965-16
Status last verified
Jun 2022
First submitted
2 Nov 2012
Last updated
28 Jun 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

    PubMed 32198149

  • Rizvi NA, Mazieres J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Mar;16(3):257-65. doi: 10.1016/S1470-2045(15)70054-9. Epub 2015 Feb 20.

    PubMed 25704439

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Squamous Cell Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 33 sites in 4 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 5 inclusion and 6 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, France, Germany, Italy. 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 Oct 2015). 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) as Assessed by Independent Radiology Review Committee (IRC) (time frame: Day 1 of treatment up to approximately 14 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 NCT01721759, which also lists 2 linked publications.

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 28 Jun 2022.

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