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

Part of paid clinical trials in Sacramento, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01721759
Phase
PHASE2
Status
Completed

Conditions

  • Squamous Cell Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 16, 2012
Status verified
Jun 2022
Primary completion
Jan 22, 2014
Completion
Apr 22, 2021

Study Design

Enrollment
117 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab, 3 mg/kg
    Participants 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.

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 ]

Locations (20)

FacilityCityStateZIPSite coordinators
University Of California Davis Medical CenterSacramentoCalifornia95817-
Va San Diego Healthcare SystemSan DiegoCalifornia92161-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Winship Cancer Institute.AtlantaGeorgia30322-
Local InstitutionMetairieLouisiana70006-
Tufts Medical CenterBostonMassachusetts02111-
Providence Cancer InstituteSouthfieldMichigan48075-
Mayo ClinicRochesterMinnesota55905-
Roswell Park Cancer InstituteBuffaloNew York14263-
Beth Israel Comprehensive Cancer CenterNew YorkNew York10011-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
University Of North Carolina At Chapel HillChapel HillNorth Carolina27599-7305-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State UniversityColumbusOhio43210-
Oregon Health & Science UniversityPortlandOregon97239-
Providence Oncology And HematologyPortlandOregon97213-
Network Office of Research and InnovationAllentownPennsylvania18103-
University Of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Henry-Joyce Cancer CenterNashvilleTennessee37232-
Oncology Consultants, PaHoustonTexas77024-

Find similar trials in Sacramento, CA

By research site
University Of California Davis Medical Center· Sacramento, CAVa San Diego Healthcare System· San Diego, CAH. Lee Moffitt Cancer Center & Research Institute· Tampa, FLWinship Cancer Institute.· Atlanta, GALocal Institution· Metairie, LATufts Medical Center· Boston, MA

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