Newly Diagnosed High Grade GliomaPhase 1NCT03425292
A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer
A Phase 1 study testing Temozolomide, conformal brain radiation therapy and Nivolumab in people with Newly Diagnosed High Grade Glioma, run by Saint John's Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and tolerability of the research study drugs nivolumab, ipilimumab, lomustine, bevacizumab, and temozolomide when used following surgery and before standard therapy with radiation and temozolomide in patients with newly diagnosed high grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed High Grade Glioma
- What is being tested?
- Temozolomide, conformal brain radiation therapy and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 27 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.
- Participant has the willingness to comply with all study procedures and availability for the duration of the study.
- Participant is being evaluated for a potential, or known, diagnosis of high grade glioma.
- Participant is a candidate for brain surgery or has undergone prior surgery and has not received any additional treatment for high grade glioma.
- Participant is male or female, ≥ 18 years of age.
- Participant has a Karnofsky Performance Status (KPS) ≥ 60%:
Who cannot join
- Participant has received prior anti-cancer treatment for high grade glioma.
- Participant has a diagnosis of immunodeficiency or active autoimmune disease.
- Participant is receiving chronic systemic steroid therapy in dosing exceeding 8 mg daily of dexamethasone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Note: This is assessed after surgery, prior to starting drug treatment.
- Participant has received a live vaccine within 28 days prior to the first dose of study agent. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), typhoid vaccine, and intranasal influenza vaccines (e.g., FluMist®).
- Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
- Participant is a female of childbearing potential who is pregnant or nursing.
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- Participant has a history of thrombotic or hemorrhagic stroke or myocardial infarction within 6 months.
- Participant has a history of intestinal perforations, fistula, hemorrhages, and/or hemoptysis ≤ 6 months prior to first study treatment.
- Participant has active gastrointestinal bleeding.
- Participant has uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg).
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint John's Cancer Institute
Santa Monica, California, 90404
About this study
The purpose of this study is to test the safety and tolerability of the research study drugs nivolumab, ipilimumab, lomustine, bevacizumab, and temozolomide when used following surgery and before standard therapy with radiation and temozolomide in patients with newly diagnosed high grade glioma.
Additional aims of the study are to:
- Find out side effects (good and bad) of study drug combinations.
- Evaluate any preliminary evidence of anticancer activity of study drug combinations .
- Evaluate tumor characteristics by collecting brain tumor tissue samples.
- Measure the amount of nivolumab and ipilimumab in biospecimens.
- Look at biomarkers in biospecimens.
Read the detailed description
Patients having a clinically planned surgical procedure (biopsy or cytoreduction) for a suspected diagnosis of high grade glioma will be approached for participation in this study. Tumor tissue obtained from surgery will be used for histological diagnosis and clinical molecular profiling, and excess tumor tissue will be collected for potential correlative studies. A small sample of blood and CSF for research will also be collected.
Once a diagnosis of high grade glioma is confirmed, the patient will be allocated to one of the study arms. Treatment will be started approximately 7-42 days following surgery once the patient has recovered from surgery. Routine clinical evaluations will be performed prior to treatment initiation and throughout treatment as clinically indicated. Radiographic brain imaging will be performed approximately 21-42 after treatment initiation and then routinely for medical management. Tumor response will be assessed according to immunotherapy Response Assessment in Neuro-Oncology (iRANO) Working Group criteria.
Treatment may continue until the patient experiences unacceptable toxicity or clear disease progression. The determination of whether to stop treatment due to disease progression will be based on the investigator's evaluation of the patient's clinical and radiographic condition, taking into consideration the interpretation of localized inflammatory responses that can mimic radiographic features of tumor progress. Patients discontinuing treatment will have further medical management as directed by their treating physician.
As part of follow-up, if the patient undergoes a surgery, results of clinical molecular profiling will be collected, and excess resected tumor tissue will be collected if available along with blood and CSF for correlative studies. A record of any additional anti-cancer treatments and survival status will be made every three to six months.
- Conditions
- Newly Diagnosed High Grade Glioma
- Being tested
- Temozolomide, conformal brain radiation therapy, Nivolumab, Ipilimumab, Bevacizumab
- Keywords
- immunotherapy, nivolumab, ipilimumab, bevcizumab, temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called temodar
concomitant and 5-day adjuvant temozolomide
conformal brain radiation therapyRadiation
standard radiation therapy for newly diagnosed glioblastoma
NivolumabDrug
Also called opdivo
nivolumab 240 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks
IpilimumabDrug
Also called yervoy
ipilimumab 1 mg/kg IV every 6 weeks (or every 8 weeks when nivolumab is administered every 4 weeks) for a maximum of 4 doses
BevacizumabDrug
Also called avastin
bevacizumab 5 mg/kg IV every 2 weeks (up to 10 mg/kg at treating physician's discretion)
5-day TemozolomideDrug
Also called temodar
150 mg/m^2 oral, once daily on Days 1-5 of each 28-day cycle (stepwise titration every cycle up to 200 mg/m^2 permitted)
5-day TemozolomideDrug
Also called temodar
100 mg/m^2 oral, once daily on Days 2-6 of each 6 week course (stepwise titration every cycle up to 200 mg/m^2 permitted)
LomustineDrug
Also called CCNU
100 mg/m^2 oral, on Day 1 of each 6 week course
Nivolumab monotherapyDrug
Also called opdivo
nivolumab 300 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 SOC (closed to enrollment) | Active comparator | Standard conformal brain radiation therapy with concurrent and adjuvant temozolomide Receives: Drug: Temozolomide; Radiation: conformal brain radiation therapy |
| 2 Nivo | Experimental | Nivolumab Receives: Drug: Nivolumab monotherapy |
| 3 Nivo-Ipi (closed to enrollment) | Experimental | Nivolumab plus Ipilimumab Receives: Drug: Nivolumab; Drug: Ipilimumab |
| 4 Nivo-Ipi-CCNU-TMZ | Experimental | Nivolumab plus Ipilimumab plus Lomustine (CCNU) plus 5-day Temozolomide Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: 5-day Temozolomide; Drug: Lomustine |
| 5 Nivo-Ipi-TMZ | Experimental | Nivolumab plus Ipilimumab plus 5-day Temozolomide Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: 5-day Temozolomide |
| 6 Nivo-Ipi-Bev-TMZ | Experimental | Nivolumab plus Ipilimumab plus Bevacizumab plus 5-day Temozolomide Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Bevacizumab; Drug: 5-day Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose limiting toxicities
treatment-related adverse events that impact administration of treatment
Measured: first 28 days of treatment
Secondary outcomes (6)
Treatment-related adverse events
Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03.
Measured: approximately 7 months
Tumor response rates
Evidence of anti-tumor activity as measured according to immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria.
Measured: up to 5 years
Progression free survival (PFS)
The duration of time from start of treatment until objective tumor response.
Measured: up to 5 years
Overall survival (OS)
The duration of time from start of treatment to death.
Measured: up to 5 years
Levels of immunotherapeutic agents in specimens
Immunotherapeutic drug levels in specimens.
Measured: approximately 4 months
Change in clinical molecular profile of tumor tissue after treatment
Comparison of tumor tissue molecular profile generated from before and after study treatment.
Measured: approximately 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Mar 2018
- Primary completion12 Sep 2022
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newly Diagnosed High Grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santosh Kesari, Saint John's Cancer Institute
- Investigators
- Santosh Kesari, MD, PhD, Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425292
- Sponsor's protocol ID
- JWCI-17-0801
- Status last verified
- Nov 2023
- First submitted
- 21 Jan 2018
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Complete de-identified patient data set will be available upon reasonable request to the principal investigator.
Publications
Kesari S, Wojcinski A, Pabla S, Seager RJ, Gill JM, Carrillo JA, Wagle N, Park DJ, Nguyen M, Truong J, Takasumi Y, Chaiken L, Chang SC, Barkhoudarian G, Kelly DF, Juarez TM. Pre-radiation Nivolumab plus ipilimumab in patients with newly diagnosed high-grade gliomas. Oncoimmunology. 2024 Dec 31;13(1):2432728. doi: 10.1080/2162402X.2024.2432728. Epub 2024 Nov 21.
PubMed 39572979
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer
- ClinicalTrials.gov ID
- NCT03425292
- Acronym / sponsor ID
- JWCI-17-0801
- Conditions
- Newly Diagnosed High Grade Glioma
- Keywords
- immunotherapy, nivolumab, ipilimumab, bevcizumab, temozolomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and tolerability of the research study drugs nivolumab, ipilimumab, lomustine, bevacizumab, and temozolomide when used following surgery and before standard therapy with radiation and temozolomide in patients with newly diagnosed high grade glioma.
Additional aims of the study are to:
- Find out side effects (good and bad) of study drug combinations.
- Evaluate any preliminary evidence of anticancer activity of study drug combinations .
- Evaluate tumor characteristics by collecting brain tumor tissue samples.
- Measure the amount of nivolumab and ipilimumab in biospecimens.
- Look at biomarkers in biospecimens.
Detailed description
Patients having a clinically planned surgical procedure (biopsy or cytoreduction) for a suspected diagnosis of high grade glioma will be approached for participation in this study. Tumor tissue obtained from surgery will be used for histological diagnosis and clinical molecular profiling, and excess tumor tissue will be collected for potential correlative studies. A small sample of blood and CSF for research will also be collected.
Once a diagnosis of high grade glioma is confirmed, the patient will be allocated to one of the study arms. Treatment will be started approximately 7-42 days following surgery once the patient has recovered from surgery. Routine clinical evaluations will be performed prior to treatment initiation and throughout treatment as clinically indicated. Radiographic brain imaging will be performed approximately 21-42 after treatment initiation and then routinely for medical management. Tumor response will be assessed according to immunotherapy Response Assessment in Neuro-Oncology (iRANO) Working Group criteria.
Treatment may continue until the patient experiences unacceptable toxicity or clear disease progression. The determination of whether to stop treatment due to disease progression will be based on the investigator's evaluation of the patient's clinical and radiographic condition, taking into consideration the interpretation of localized inflammatory responses that can mimic radiographic features of tumor progress. Patients discontinuing treatment will have further medical management as directed by their treating physician.
As part of follow-up, if the patient undergoes a surgery, results of clinical molecular profiling will be collected, and excess resected tumor tissue will be collected if available along with blood and CSF for correlative studies. A record of any additional anti-cancer treatments and survival status will be made every three to six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 SOC (closed to enrollment) | Active comparator | Drug: Temozolomide, Radiation: conformal brain radiation therapyStandard conformal brain radiation therapy with concurrent and adjuvant temozolomide |
| 2 Nivo | Experimental | Drug: Nivolumab monotherapyNivolumab |
| 3 Nivo-Ipi (closed to enrollment) | Experimental | Drug: Nivolumab, Drug: IpilimumabNivolumab plus Ipilimumab |
| 4 Nivo-Ipi-CCNU-TMZ | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: 5-day Temozolomide, Drug: LomustineNivolumab plus Ipilimumab plus Lomustine (CCNU) plus 5-day Temozolomide |
| 5 Nivo-Ipi-TMZ | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: 5-day TemozolomideNivolumab plus Ipilimumab plus 5-day Temozolomide |
| 6 Nivo-Ipi-Bev-TMZ | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: Bevacizumab, Drug: 5-day TemozolomideNivolumab plus Ipilimumab plus Bevacizumab plus 5-day Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.
- Participant has the willingness to comply with all study procedures and availability for the duration of the study.
- Participant is being evaluated for a potential, or known, diagnosis of high grade glioma.
- Participant is a candidate for brain surgery or has undergone prior surgery and has not received any additional treatment for high grade glioma.
- Participant is male or female, ≥ 18 years of age.
Key exclusion criteria (10 listed)
- Participant has received prior anti-cancer treatment for high grade glioma.
- Participant has a diagnosis of immunodeficiency or active autoimmune disease.
- Participant is receiving chronic systemic steroid therapy in dosing exceeding 8 mg daily of dexamethasone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Note: This is assessed after surgery, prior to starting drug treatment.
- Participant has received a live vaccine within 28 days prior to the first dose of study agent. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), typhoid vaccine, and intranasal influenza vaccines (e.g., FluMist®).
- Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemozolomideAlso: temodarconcomitant and 5-day adjuvant temozolomide | Drug | 1 SOC (closed to enrollment) |
| conformal brain radiation therapystandard radiation therapy for newly diagnosed glioblastoma | Radiation | 1 SOC (closed to enrollment) |
| NivolumabAlso: opdivonivolumab 240 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks | Drug | 3 Nivo-Ipi (closed to enrollment), 4 Nivo-Ipi-CCNU-TMZ, 5 Nivo-Ipi-TMZ, 6 Nivo-Ipi-Bev-TMZ |
| IpilimumabAlso: yervoyipilimumab 1 mg/kg IV every 6 weeks (or every 8 weeks when nivolumab is administered every 4 weeks) for a maximum of 4 doses | Drug | 3 Nivo-Ipi (closed to enrollment), 4 Nivo-Ipi-CCNU-TMZ, 5 Nivo-Ipi-TMZ, 6 Nivo-Ipi-Bev-TMZ |
| BevacizumabAlso: avastinbevacizumab 5 mg/kg IV every 2 weeks (up to 10 mg/kg at treating physician's discretion) | Drug | 6 Nivo-Ipi-Bev-TMZ |
| 5-day TemozolomideAlso: temodar150 mg/m^2 oral, once daily on Days 1-5 of each 28-day cycle (stepwise titration every cycle up to 200 mg/m^2 permitted) | Drug | 5 Nivo-Ipi-TMZ, 6 Nivo-Ipi-Bev-TMZ |
| 5-day TemozolomideAlso: temodar100 mg/m^2 oral, once daily on Days 2-6 of each 6 week course (stepwise titration every cycle up to 200 mg/m^2 permitted) | Drug | 4 Nivo-Ipi-CCNU-TMZ |
| LomustineAlso: CCNU100 mg/m^2 oral, on Day 1 of each 6 week course | Drug | 4 Nivo-Ipi-CCNU-TMZ |
| Nivolumab monotherapyAlso: opdivonivolumab 300 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks | Drug | 2 Nivo |
Primary outcome
Rate of dose limiting toxicities
Time frame: first 28 days of treatment
treatment-related adverse events that impact administration of treatment
6 secondary outcomes
Treatment-related adverse events
Time frame: approximately 7 months
Tumor response rates
Time frame: up to 5 years
Progression free survival (PFS)
Time frame: up to 5 years
Overall survival (OS)
Time frame: up to 5 years
Levels of immunotherapeutic agents in specimens
Time frame: approximately 4 months
Change in clinical molecular profile of tumor tissue after treatment
Time frame: approximately 6 months to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 39572979Kesari S, Wojcinski A, Pabla S, Seager RJ, Gill JM, Carrillo JA, Wagle N, Park DJ, Nguyen M, Truong J, Takasumi Y, Chaiken L, Chang SC, Barkhoudarian G, Kelly DF, Juarez TM. Pre-radiation Nivolumab plus ipilimumab in patients with newly diagnosed high-grade gliomas. Oncoimmunology. 2024 Dec 31;13(1):2432728. doi: 10.1080/2162402X.2024.2432728. Epub 2024 Nov 21.
- Individual participant dataSharing planned: Yes. Complete de-identified patient data set will be available upon reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santosh Kesari, MD, PhD principal investigator
Saint John's Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Temozolomide, conformal brain radiation therapy and Nivolumab in people with Newly Diagnosed High Grade Glioma, run by Saint John's Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dose limiting toxicities (time frame: first 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.