An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC (Checkmate 171)
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ClinicalTrials.gov Identifier: NCT02409368 |
Recruitment Status :
Completed
First Posted : April 6, 2015
Results First Posted : July 29, 2021
Last Update Posted : November 14, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Nivolumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 812 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC |
Actual Study Start Date : | April 29, 2015 |
Actual Primary Completion Date : | March 7, 2018 |
Actual Study Completion Date : | August 27, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
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Drug: Nivolumab |
- Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events [ Time Frame: From first dose to time of analysis of primary endpoint (approximately up to 34 months) ]The total number of participants with high grade treatment related select adverse events.
- Number of Participants With High Grade Select Adverse Events [ Time Frame: From first dose up to 100 days post last dose (up to 76 months) ]The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
- Median Time to Onset of Any Grade Select Adverse Events [ Time Frame: From first dose up to 100 days post last dose (up to approximately 65 months) ]Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
- Median Time to Resolution of Any Grade Select Adverse Events [ Time Frame: From first dose to up to 100 days post last dose (up to approximately 45 months) ]Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
- Overall Survival [ Time Frame: From the first dosing up to the date of death (up to approximately 76 months) ]Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
- Objective Response Rate (ORR) [ Time Frame: From first dose up to last dose (up to approximately 76 months) ]ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- ECOG Status: PS 0-1 & PS 2
- Subjects with histologically or cytologically-documented SqNSCLC
- Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
- Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
- Subjects with treated or asymptomatic CNS metastases
- Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
- Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
- Males and Females, ages 18 or older
Exclusion Criteria:
- Subjects with untreated, symptomatic CNS metastases
- Subjects with carcinomatous meningitis
- Subjects with active, known or suspected autoimmune disease.
- Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409368
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02409368 |
Other Study ID Numbers: |
CA209-171 2014-001285-10 ( EudraCT Number ) |
First Posted: | April 6, 2015 Key Record Dates |
Results First Posted: | July 29, 2021 |
Last Update Posted: | November 14, 2022 |
Last Verified: | October 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |