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
CompletedPhase 2Results postedLast updated 28 June 2022
What this trial tests
Phase 2 trial testing Nivolumab in Squamous Cell Non-small Cell Lung Cancer in 117 participants. Completed in 22 April 2021.
18 and older, any sex, with Squamous Cell Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)Primary· Day 1 of treatment up to approximately 14 months
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.
Group
Value
95% CI
Nivolumab, 3 mg/kg
14.5
8.7 – 22.2
Objective Response Rate (ORR) as Assessed by InvestigatorSecondary· Day 1 of treatment to approximately 101 months
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.
Group
Value
95% CI
Nivolumab, 3 mg/kg
15.4
9.4 – 23.2
Duration of Response (DOR) as Assessed by InvestigatorSecondary· From the first treatment to the date of the first documented tumor progression or death. Approximately up to 101 months
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
Group
Value
95% CI
Nivolumab, 3 mg/kg
16.00
12.45 – 29.54
Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC)Primary· From the first treatment to the date of the first documented tumor progression or death. Approximately up to 14 months
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
Group
Value
95% CI
Nivolumab, 3 mg/kg
12
6.7 – 19.3
Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC)Secondary· From the first treatment to the date of the first documented tumor progression or death. Approximately up to 21 months
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
Group
Value
95% CI
Nivolumab, 3 mg/kg
NA
8.31 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first visit to 100 days after last treatment. Approximately up to 101 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab, 3 mg/kg
Serious: 88/117 (75%)
Deaths: 108/117
Serious adverse events (84 terms)
Reaction
System
Nivolumab, 3 mg/kg
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
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NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
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NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
Other recruiting trials for Squamous Cell Non-small Cell Lung Cancer
Currently open trials in the same condition.
NCT05429463 — Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ）
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Other Bristol-Myers Squibb trials
Trials by the same sponsor.
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NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 28 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01721759.