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Angiogenesis Inhibitor

Combination Therapy for Brain Cancer

Phase 1
Waitlist Available
Led By Santosh Kesari, MD, PhD
Research Sponsored by John Wayne Cancer Institute
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 5 years
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of using nivolumab, ipilimumab, lomustine, bevacizumab, and temozolomide after surgery and before standard therapy with radiation and temozolomide in patients with newly diagnosed high grade glioma.

Eligible Conditions
  • High Grade Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Rate of dose limiting toxicities
Secondary outcome measures
Change in clinical molecular profile of tumor tissue after treatment
Levels of immunotherapeutic agents in specimens
Overall survival (OS)
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: 6 Nivo-Ipi-Bev-TMZExperimental Treatment4 Interventions
Nivolumab plus Ipilimumab plus Bevacizumab plus 5-day Temozolomide
Group II: 5 Nivo-Ipi-TMZExperimental Treatment3 Interventions
Nivolumab plus Ipilimumab plus 5-day Temozolomide
Group III: 4 Nivo-Ipi-CCNU-TMZExperimental Treatment4 Interventions
Nivolumab plus Ipilimumab plus Lomustine (CCNU) plus 5-day Temozolomide
Group IV: 3 Nivo-Ipi (closed to enrollment)Experimental Treatment2 Interventions
Nivolumab plus Ipilimumab
Group V: 2 NivoExperimental Treatment2 Interventions
Nivolumab
Group VI: 1 SOC (closed to enrollment)Active Control2 Interventions
Standard conformal brain radiation therapy with concurrent and adjuvant temozolomide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Bevacizumab
2013
Completed Phase 4
~5280
5-day Temozolomide
2018
Completed Phase 1
~50
Lomustine
2008
Completed Phase 3
~1540
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

John Wayne Cancer InstituteLead Sponsor
21 Previous Clinical Trials
5,500 Total Patients Enrolled
Saint John's Cancer InstituteLead Sponsor
25 Previous Clinical Trials
6,978 Total Patients Enrolled
Santosh Kesari, MD, PhD4.713 ReviewsPrincipal Investigator - Saint John's Cancer Institute
John Wayne Cancer Institute
8 Previous Clinical Trials
147 Total Patients Enrolled
5Patient Review
The physician and staff were amazing.

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03425292 — Phase 1
Gliomas Research Study Groups: 1 SOC (closed to enrollment), 2 Nivo, 3 Nivo-Ipi (closed to enrollment), 4 Nivo-Ipi-CCNU-TMZ, 5 Nivo-Ipi-TMZ, 6 Nivo-Ipi-Bev-TMZ
Gliomas Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03425292 — Phase 1
Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03425292 — Phase 1

Frequently Asked Questions

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

Is this medical experiment unprecedented in its design?

"Currently, 1,303 active studies regarding lomustine are being conducted in 2,965 cities and 69 countries. Originally initiated by Schering-Plough in 2002 with 60 participants to reach Phase 2 drug approval stage, this project has since seen the completion of 1,638 trials."

Answered by AI

Are there any comparable investigations involving Lomustine?

"At present, there are 1303 active studies of Lomustine with 194 trials in the third phase. Houston is a common research site for this medication; however, there are 64013 other clinical trial venues testing it as well."

Answered by AI

What medical conditions does Lomustine usually address?

"Lomustine is most frequently prescribed for the management of malignant tumours. It has also been proven to be effective in treating ailments such as unresectable melanoma, squamous cell carcinoma, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

How many participants are eligible to take part in this clinical trial?

"Affirmative. Clinicaltrials.gov's records demonstrate that recruitment for this study, initially posted on March 1st 2018, is still in progress. To complete the trial 90 patients need to be enrolled from a single site."

Answered by AI

Are there any open slots for participants in this research study?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical experiment is currently enlisting individuals for participation. The trial was initially publicized on March 1st 2018 and last refreshed on May 18th 2022; it requires 90 patients from a single site."

Answered by AI

What risks do patients take when using Lomustine?

"In consideration of the limited data available attesting to its safety and efficacy, Lomustine is assigned a score of 1 on our team's rating scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer
Santosh Kesari 2018. "A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03425292.
~7 spots leftby Apr 2025
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