An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combi... | Not Recruiting
An Investigational Immuno-therapy S... | Not Recruiting
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
CheckMate 451

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Medical Conditions
  • Lung Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02538666
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab followed by Nivolumab by itself, will prolong overall survival and progression free survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Biological : Nivolumab, Biological : Ipilimumab, Other : Placebo

Study Arm Groups : Nivolumab monotherapy, Nivolumab and ipilimumab combination therapy, Nivolumab and ipilimumab combination therapy, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Overall Survival (OS); Approximately 30 months after the first subject is randomized; Progression-free survival (PFS); Approximately 6 months after the last subject is randomized
Secondary Outcome Measures
    A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen; Approximately 30 months; An OS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen; Approximately 30 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
810
Participant Inclusion Criteria
    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:

    - Subjects with histologically or cytologically confirmed extensive stage disease SCLC

    - Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    Exclusion Criteria:

    - Subjects with symptomatic Central Nervous System (CNS) metastases

    - Subjects receiving consolidative chest radiation

    - Subjects with active, known, or suspected autoimmune disease are excluded

    - All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Truro
TR1 3LJ
London
NW1 2PG
Oxford
OX3 7LJ
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Sheffield
S10 2SJ
The Clatterbridge Cancer Centre NHS Foundation Trust
Birkenhead
CH63 4JY
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)
EudraCT Number
Not available for this trial
Funder(s)
  • Ono Pharmaceutical Co. Ltd
Other Study ID Numbers
CA209-451
Sponsor(s)
Bristol-Myers Squibb
Key Dates

Recruitment Start Date

Sep 2015

Recruitment End Date

Sep 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

26 Aug 2015

Date updated in source

06 Nov 2017