A Phase 3 Study of Nivolumab, or Nivolumab with Ipilimumab, or Placebo in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) after Completing Platinum-based First Line Chemotherapy at multiple sites.

• Register: EUCTR
• Last refreshed on: 24 January 2022
• Main ID: EUCTR2015-002441-61-AT
• Date of registration: 21/12/2015
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb International Corporation
• Public title: A Phase 3 Study of Nivolumab, or Nivolumab with Ipilimumab, or Placebo in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) after Completing Platinum-based First Line Chemotherapy at multiple sites.
• 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
• Date of first enrolment: 19/01/2016
• Target sample size: 1012
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002441-61
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Denmark, 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

Contacts

• Name: GCT-SU
• Affiliation: Bristol-Myers Squibb International Corporation

• Name: GCT-SU
• Affiliation: Bristol-Myers Squibb International Corporation

Key inclusion & exclusion criteria

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
-ECOG performance status of 0 or 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 607
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 405

Exclusion criteria:
-Subjects with untreated central nervous system metastases are excluded
-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
-Symptomatic CNS metastases
-consolidation chest radiation


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Extensive stage disease small cell lung cancer who have completed first line chemotherapy
MedDRA version: 20.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Nivolumab
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558-01
Other descriptive name: BMS936558
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Product Name: Ipilimumab
Product Code: BMS-734016
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPILIMUMAB
CAS Number: 477202-00-9
Current Sponsor code: BMS-734016
Other descriptive name: BMS734016
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): - Overall Survival
- Progression-free survival

Secondary Objective: _To compare OS of nivolumab versus placebo in subjects with ED-SCLC after completion of platinum-based first
line chemotherapy
_To evaluate (descriptively) Overall Survival and BICR (Blinded Independent Central Review)-assessed Progression-Free Survival of nivolumab combined with ipilimumab versus nivolumab monotherapy.
_ To compare Blinded Independent Central Review (BICR) assessed PFS of nivolumab, and nivolumab in combination with ipilimumab versus placebo
_To evaluate tumor mutational burden as a predictive biomarker for OS and PFS of nivolumab, and nivolumab in combination with ipilimumab

Timepoint(s) of evaluation of this end point: - OS: Approximately 35 months after the first subject is randomized
- PFS: Approximately 35 months after the last subject is randomized

Main Objective: The purpose of this study is to show that maintenance therapy with nivolumab, or nivolumab plus ipilimumab followed by nivolumab alone, will prolong Overall Survival compared with placebo in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy.

Secondary Outcome(s)

Secondary end point(s): -Descriptive analysis of PFS and OS to evaluate nivolumab monotherapy to nivolumab with ipilimumab treatment regimen
_to compare OS of nivolumab versus placebo

Timepoint(s) of evaluation of this end point: Approximately 35 months

Secondary ID(s)

NCT02538666

2015-002441-61-BE

CA209-451

Source(s) of Monetary Support

Bristol-Myers Squibb International Corporation

Ethics review

Status: Approved
Approval date: 19/01/2016
Contact: