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Monoclonal Antibodies

Pharmacological Study for Glioblastoma

Phase 1
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying the safety and best dose of the anti-LAG-3 antibody or urelumab alone and in combination with nivolumab to treat patients with recurrent glioblastoma.

Eligible Conditions
  • Glioblastoma
  • Gliosarcoma
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD of Anti-CD137 + Anti-PD-1 as determined by frequency of toxicity
MTD of Anti-LAG-3 + Anti-PD-1 as determined by frequency of toxicity
Maximum tolerated dose (MTD) of anti-CD137 as monotherapy as determined by frequency of toxicity
+1 more
Secondary outcome measures
Overall Response to Anti-LAG-3 + Anti-PD-1, assessed by RANO and iRANO
Overall Response to anti-CD137 as monotherapy, assessed by RANO and iRANO
Overall Response to anti-LAG-3 monoclonal antibody BMS-98601, assessed by RANO and iRANO
+3 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Intratumoral StudiesExperimental Treatment5 Interventions
Patients pre-operatively receive either anti-LAG-3 monoclonal antibody BMS-986016 (Arm A1), or urelumab (Arm A2), or nivolumab and anti-LAG-3 monoclonal antibody BMS-986016 as in Part B (B1)), or nivolumab and urelumab as in Part B (B2). Within 45 days of surgical resection, patients post-operatively receive drug from one of the four arms. (3pts enrolled before the Anti-CD137 antibody (BMS-663513 - urelumab) treatment arm closed by BMS on 10/16/18 due to closure of BMS Urelumab development program. Subjects currently on treatment may continue.)
Group II: B2 Anti-CD137 + Anti-PD-1Experimental Treatment4 Interventions
Patients receive Anti-PD-1 (nivolumab) IV over 60 minutes on days 1 and 15 and Anti-CD137 (urelumab) IV on day 1. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. (2pts enrolled before the Anti-CD137 antibody (BMS-663513 - urelumab) treatment arm closed by BMS on 10/16/18 due to closure of BMS Urelumab development program. Subjects currently on treatment may continue.) Pharmacological Study Laboratory Biomarker Analysis
Group III: B1 Anti-LAG3 + Anti-PD-1 (nivolumab)Experimental Treatment3 Interventions
Patients receive Anti-PD-1 (nivolumab) IV over 60 minutes and anti-LAG-3 monoclonal antibody BMS-986016 IV on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Pharmacological Study Laboratory Biomarker Analysis
Group IV: A2 Anti-CD137 (Urelumab)Experimental Treatment2 Interventions
Patients receive Anti-CD137 (Urelumab) IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity Pharmacological Study Laboratory Biomarker Analysis
Group V: A1 Anti-LAG-3Experimental Treatment3 Interventions
Patients receive Anti-LAG-3 monoclonal antibody BMS-986016 IV over 60 minutes and on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Pharmacological Study Laboratory Biomarker Analysis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anti-CD137
2016
Completed Phase 1
~70
Anti-LAG-3 Monoclonal Antibody BMS 986016
2016
Completed Phase 1
~70
Anti-PD-1
2016
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,837 Total Patients Enrolled
31 Trials studying Glioblastoma
920 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,062 Total Patients Enrolled
322 Trials studying Glioblastoma
23,052 Patients Enrolled for Glioblastoma
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,451 Total Patients Enrolled
19 Trials studying Glioblastoma
2,753 Patients Enrolled for Glioblastoma

Media Library

Anti-CD137 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02658981 — Phase 1
Glioblastoma Research Study Groups: B1 Anti-LAG3 + Anti-PD-1 (nivolumab), A2 Anti-CD137 (Urelumab), B2 Anti-CD137 + Anti-PD-1, Intratumoral Studies, A1 Anti-LAG-3
Glioblastoma Clinical Trial 2023: Anti-CD137 Highlights & Side Effects. Trial Name: NCT02658981 — Phase 1
Anti-CD137 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02658981 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a trial of this kind been attempted before?

"Since 2012, the effectiveness of Pharmacological Study has been investigated through clinical trials. The first examination was sponsored by Ono Pharmaceutical Co. Ltd and involved 659 patients. After gaining approval in Phase 1 & 2 Drug Trials, live studies of this medication are now present across 49 nations with 2356 cities participating in the research process."

Answered by AI

What additional research has been conducted on Pharmacological Study?

"In 2012, the Pharmacological Study was first conducted at Local Institution. Since then, 837 trials have been completed and 717 are actively recruiting patients in various locations such as Los Angeles, California."

Answered by AI

What is the recruitment scale of this research endeavor?

"This study has now closed its recruitment period, having last been updated on the 1st of December 2022. For those looking for alternative clinical trials, there are presently 1729 open studies related to gliosarcoma and 717 Pharmacological Studies recruiting patients."

Answered by AI

Are there any open slots remaining for enrolment in this trial?

"Unfortunately, this clinical trial has now closed its enrolment period. It was initially posted on August 24th 2016 and last updated on December 1st 2022. However, there are presently 1729 trials actively recruiting participants with gliosarcoma and 717 studies searching for volunteers to participate in a Pharmacological Study."

Answered by AI

What outcome is the medical research attempting to attain?

"Over the course of a four-week period, researchers will assess the Maximum Tolerated Dose (MTD) of Anti-CD137 + Anti-PD-1 via toxicity monitoring. Secondary objectives consist of determining the Overall Response Rate to anti-LAG3 monoclonal antibody BMS-98601 and two combinations - Anti–LAG3+Anti–PD1 and anti–CD137 – through RANO and iRANO evaluations. For each drug dose, these responses are estimated with an associated 95% confidence interval."

Answered by AI

What is the scale of this medical trial in terms of active sites?

"Currently, 11 medical centres are enrolling patients for this study. These include the Jonsson Comprehensive Cancer Center at UCLA in Los Angeles, Henry Ford Hospital in Detroit, Wake Forest University Comprehensive Cancer Center in Winston-Salem as well as 8 other sites."

Answered by AI

Has the Pharmacological Study been validated by the FDA?

"The safety of Pharmacological Study was evaluated as a 1 due to the dearth of data supporting its efficacy and limited research regarding its potential risks."

Answered by AI

What afflictions can be addressed through Pharmacological Study?

"Pharmacological Study can be used to treat a variety of malignant neoplasms, including the inoperable melanoma and squamous cell carcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Anti-LAG-3 Alone & in Combination w/ Nivolumab Treating Patients w/ Recurrent GBM (Anti-CD137 Arm Closed 10/16/18)
2016. "Anti-LAG-3 Alone & in Combination w/ Nivolumab Treating Patients w/ Recurrent GBM (Anti-CD137 Arm Closed 10/16/18)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02658981.
~7 spots leftby Apr 2025
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