A Randomized Study of Nivolumab Versus Bevacizumab and a Safety Study of Nivolumab in Adult Subjects With Recurrent Glioblastoma (GBM) (CheckMate 143)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02017717
First received: December 17, 2013
Last updated: February 19, 2015
Last verified: December 2014
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Purpose
The purposes of the study are to understand the
- Safety and tolerability of Nivolumab or Nivolumab in combination with Ipilimumab in a safety lead-in phase (Cohort 1 and Cohort 1b) and
- The safety, tolerability and efficacy of Nivolumab versus Bevacizumab (Cohort 2) in patients diagnosed with recurrent glioblastoma (GBM).
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Glioblastoma |
Biological: Nivolumab Biological: Bevacizumab Biological: Ipilimumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Adult Subjects With Recurrent Glioblastoma (GBM) |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Anaplastic Astrocytoma
Glioblastoma
Glioma
Gliosarcoma
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Cohort 1 and 1b: Safety and tolerability based on drug related events leading to permanent discontinuation prior to completing 4 doses [ Time Frame: Approximately up to 8 months ] [ Designated as safety issue: Yes ]
- Cohort 2: Overall Survival (OS) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
OS of Nivolumab versus Bevacizumab.
Overall Survival is defined as the time between the date of randomization and the date of death due to any cause
Secondary Outcome Measures:
- Overall Survival rate (OS) [ Time Frame: At 12 months ] [ Designated as safety issue: No ]Comparing OS between Nivolumab and Bevacizumab
- Progression Free Survival (PFS) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
Comparing PFS between Nivolumab and Bevacizumab
PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause
- Objective Response Rate(ORR) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
Comparing ORR between Nivolumab and Bevacizumab
ORR is defined as the number of subjects whose best overall response (BOR) is Complete Response (CR) or Partial Response (PR) divided by all randomized subjects
| Estimated Enrollment: | 260 |
| Study Start Date: | January 2014 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm N:Nivolumab
Cohort 1: Nivolumab 3mg/kg solution intravenously once every 2 weeks until disease progression or unacceptable toxicity
|
Biological: Nivolumab
Other Name: BMS-936558
|
|
Experimental: Arm N + I:Nivolumab + Ipilimumab
Cohort 1: Nivolumab 1mg/kg + Ipilimumab 3mg/kg every 3 weeks x 4 doses, then Nivolumab 3mg/kg every 2 weeks until disease progression or unacceptable toxicity Cohort 1b: Nivolumab 3mg/kg + Ipilimumab 1mg/kg intravenously every 3 weeks for 4 doses, then Nivolumab 3mg/kg every 2 weeks thereafter until disease progression or unacceptable toxicity |
Biological: Nivolumab
Other Name: BMS-936558
Biological: Ipilimumab
|
|
Active Comparator: Arm B: Bevacizumab
Cohort 2: Bevacizumab solution 10 mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity
|
Biological: Bevacizumab
Other Name: Avastin
|
Detailed Description:
Number of Arms: 2 in cohort 1, 1 in Cohort 1b 2 in cohort 2
Enrollment: 372 enrolled; 20 randomized to Cohort 1, 20 Non-randomized to Cohort 1b, 220 randomized to Cohort 2
Allocation: Randomized Controlled Trial: participants are assigned to intervention groups by chance (Cohort 1 and 2), For Cohort 1b, participants are assigned to a single intervention group (not randomized)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects with histologically confirmed Grade IV malignant glioma
- Previous treatment with radiotherapy and temozolomide
- Documented first recurrence of GBM
- Karnofsky performance status (PS) ≥ 70
Exclusion Criteria:
- More than one recurrence of GBM
- Presence of extracranial metastatic or leptomeningeal disease
- Active, known or suspected autoimmune disease
- Prior Bevacizumab or other anti-vascular growth factor (VEGF) or anti-angiogenic treatment
- Clinically significant cardiovascular disease
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02017717
Show 57 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02017717
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: | Clinical.Trials@bms.com | ||
| Contact: First line of the email MUST contain NCT# and Site #. |
Show 57 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02017717 History of Changes |
| Other Study ID Numbers: | CA209-143, 2013-003738-34 |
| Study First Received: | December 17, 2013 |
| Last Updated: | February 19, 2015 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Germany: Federal Institute for Drugs and Medical Devices Germany: Ministry of Health France: Agence Nationale de Sécurité du Médicament et des produits de santé Spain: Spanish Agency of Medicines Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: The Danish National Committee on Biomedical Research Ethics Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Switzerland: Federal Office of Public Health Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Poland: National Institute of Medicines Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents Growth Inhibitors Growth Substances Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015