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Monoclonal Antibodies
Anti-Tim-3 + Anti-PD-1 + SRS for Glioblastoma
Phase 1
Waitlist Available
Led By Lawrence Kleinberg, MD
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
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within -7 days prior to the start of therapy. Women must not be breastfeeding
Patients tumor target (GTV) should be ≤ 5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of initial diagnosis until the date of death from any cause assessed up to 24 months
Awards & highlights
Study Summary
This trial studies the side effects of MBG453 and spartalizumab when given together with stereotactic radiosurgery in treating patients with recurrent GBM.
Who is the study for?
This trial is for adults over 18 with recurrent GBM who've had first-line therapy including surgery, radiation, and Temozolomide. They must have a Karnofsky Performance Status ≥ 70, no more than two recurrences of GBM or gliosarcoma confirmed by biopsy or MRI, normal organ/marrow function, and be able to undergo MRIs. Women must not be pregnant/breastfeeding and use contraception.Check my eligibility
What is being tested?
The trial tests the safety of stereotactic radiosurgery combined with MBG453 and spartalizumab in treating recurrent GBM. It aims to see if this combination can better target cancer cells while sparing healthy tissue compared to current treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapy such as fatigue, allergic reactions to the monoclonal antibodies (MBG453 and spartalizumab), inflammation in organs due to immune response, as well as localized effects from the high-dose radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding and have a recent negative pregnancy test.
Select...
My tumor is 5 cm or smaller.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I've had surgery, radiation, and Temozolomide for my cancer, unless my tumor is MGMT unmethylated.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with Grade IV brain cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of initial diagnosis until the date of death from any cause assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of initial diagnosis until the date of death from any cause assessed up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 5.0
Secondary outcome measures
Objective Response
Overall survival
Progression-free survival
+1 moreSide effects data
From 2019 Phase 1 & 2 trial • 172 Patients • NCT0232573983%
Aspartate aminotransferase increased
67%
Alanine aminotransferase increased
67%
Diarrhoea
50%
Pyrexia
50%
Abdominal distension
50%
Hyperphosphataemia
33%
Blood bilirubin increased
33%
Oedema peripheral
33%
Anaemia
33%
Abdominal pain
33%
Nausea
33%
Fatigue
33%
Neutrophil count decreased
33%
Pruritus
33%
Rash
17%
Epistaxis
17%
Productive cough
17%
Liver carcinoma ruptured
17%
Tinea cruris
17%
Dysgeusia
17%
Oesophageal varices haemorrhage
17%
Hyperglycaemia
17%
Blood creatinine increased
17%
Hypokalaemia
17%
Vomiting
17%
Rash pustular
17%
Sinusitis
17%
Blood creatine phosphokinase increased
17%
Weight decreased
17%
Gamma-glutamyltransferase increased
17%
Platelet count decreased
17%
Arthralgia
17%
Myalgia
17%
Insomnia
17%
Dyspnoea exertional
17%
Hot flush
17%
Headache
17%
Cough
17%
Pneumonitis
17%
Hyperthyroidism
17%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: FGF401 120 mg + PDR001 300 mg
All Patients of Combination Dose
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
All Patients of Single Agent FGF401
Phase I: FGF401 80 mg + PDR001 300 mg
All Patients
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 80 mg Fed
Phase I: 120 mg Fasted
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (MBG453, spartalizumab, stereotactic radiosurgery)Experimental Treatment1 Intervention
Patients receive MBG453 and spartalizumab IV over 30 minutes on Day 1. Patients then undergo stereotactic radiosurgery on Day 8. Courses with MBG453 and spartalizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MBG453
2017
Completed Phase 1
~250
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,371 Total Patients Enrolled
23 Trials studying Glioblastoma
1,676 Patients Enrolled for Glioblastoma
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,884 Total Patients Enrolled
31 Trials studying Glioblastoma
967 Patients Enrolled for Glioblastoma
Lawrence Kleinberg, MDPrincipal InvestigatorJohns Hopkins University/Sidney Kimmel Cancer Center
3 Previous Clinical Trials
74 Total Patients Enrolled
2 Trials studying Glioblastoma
53 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with immune therapy, not including steroids.I have lung disease that causes symptoms or could affect lung-related side effect management.I have a known positive history of HIV or active Hepatitis B/C.I am not pregnant or breastfeeding and have a recent negative pregnancy test.I haven't had major surgery, except for brain surgery, in the last 2 weeks.My tumor is 5 cm or smaller.I am able to care for myself but may not be able to do active work.I've had surgery, radiation, and Temozolomide for my cancer, unless my tumor is MGMT unmethylated.I have an autoimmune disease but it's either mild or under control.I haven't had any vaccines for infectious diseases in the last 4 weeks.I am using or willing to use contraception during and after the study.I have had an organ or stem cell transplant.My cancer has spread outside of my brain.You have had an allergic reaction or are very sensitive to any of the ingredients in the study drug.I am 18 years old or older.I've been cancer-free for 5 years, or had certain low-risk cancers treated.I've been taking more than 4 mg of dexamethasone or similar medication daily for at least 5 days.I have a controlled neurological condition not related to my cancer.I have been diagnosed with Grade IV brain cancer.My brain tumor has come back no more than 2 times and has been confirmed.It has been over 30 days since my last chemotherapy session.I have recovered from any serious side effects of my previous treatments.My organ and bone marrow functions are normal.I've had specific brain radiation but either have confirmed tumor recurrence or new MRI changes outside the treated area.You are able to have an MRI scan.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (MBG453, spartalizumab, stereotactic radiosurgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Will MBG453 usage have any detrimental effects on patients?
"Judging from the available evidence, MBG453's safety rating is 1 on a scale of 1 to 3. This can be attributed to this being Phase I trial with limited data confirming its efficacy and safety."
Answered by AI
Is this trial a pioneering venture into new territory?
"Currently, Novartis Pharmaceuticals has 37 active trials for MBG453 distributed over 44 nations and 207 cities. This drug first entered clinical testing in 2011 with the goal of passing its Phase 1 approval stage; since then 21 studies have been completed successfully."
Answered by AI
Is this research study still open to participants?
"Unfortunately, the trial is not presently accepting new participants. It was first posted on February 18th 2020 and last updated November 22nd 2022. If you're looking for other trials however, there are currently 442 glioblastoma studies recruiting patients as well as 37 clinical trials in need of MBG453 test subjects."
Answered by AI
What prior research has been conducted involving MBG453?
"A total of 37 clinical trials dedicated to MBG453 are underway, two of which have progressed into the third phase. The vast majority of these medical studies take place in New york City, yet 873 sites across the world are running their own investigations."
Answered by AI
What is the sample size of this experiment?
"Unfortunately, there is no current recruitment for this clinical trial. It was first listed on February 18th 2020 and its information has been most recently updated on November 22nd 2022. If you are looking to participate in other trials, 442 studies that deal with glioblastoma have open registration while 37 others involve MBG453 and need participants."
Answered by AI
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