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Cancer Vaccine

Personalized Cancer Vaccine + RT + Pembrolizumab for Glioblastoma

Phase 1

Recruiting

Led By David A. Reardon, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status ≥ 70

Pathologically confirmed WHO grade IV glioblastoma or variants (gliosarcoma, glioblastoma with oligodendroglial features, giant cell glioblastoma) with adequate tumor material for genomic sequencing. Participants will be eligible if the original diagnosis was a lower grade glioma and a subsequent histologic diagnosis of glioblastoma or its variants was made, and patient received no prior therapy other than surgery

Must not have

Stereotactic biopsy (without further resection);

Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new type of vaccine as a possible treatment for patients with glioblastoma. It is evaluating the safety of the vaccine and finding the right dose to use.

Who is the study for?

Adults with newly diagnosed glioblastoma who can undergo specific imaging tests, are not pregnant or breastfeeding, and agree to use contraception. They should have a certain performance status indicating they can carry out daily activities and must not be on corticosteroids. Prior cancer treatments other than surgery for glioblastoma are disqualifying.

What is being tested?

The trial is testing a new vaccine made from the patient's tumor characteristics combined with radiation therapy and Pembrolizumab (an immunotherapy drug). It aims to see if this personalized vaccine can safely stimulate the immune system to fight brain cancer cells.

What are the potential side effects?

Potential side effects include allergic reactions related to vaccines, issues from live vaccines taken recently, autoimmune disease flare-ups, infections requiring treatment, heart problems, planned major surgeries interfering with treatment, or adverse events from previous therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but may not be able to do active work.

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I have a specific type of brain tumor (glioblastoma) and haven't received treatment other than surgery.

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My post-surgery scan shows remaining tumor is less than 1 cm big.

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My blood, kidney, and liver functions are within normal ranges.

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My tumor is located above the cerebellum, as confirmed by scans before surgery.

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My diagnosis is astrocytoma with features of glioblastoma.

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My cancer's MGMT status was tested and is known.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a precise biopsy without further surgery.

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I haven't had cancer treatment in the last 2 weeks or I've recovered from side effects.

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I have or had lung inflammation that needed steroids.

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I have not received a live vaccine in the last 30 days.

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I have an active tuberculosis infection.

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I do not have any uncontrolled illnesses like severe infections or heart problems.

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I have HIV or hepatitis but my viral load is undetectable.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I am scheduled for a major surgery soon.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort 1: Number of participants who are clinically able to initiate post-RT vaccine therapy within 12 weeks or less from date of surgery

Cohort 1: Number of participants with at least 10 actionable peptides as a measure of study feasibility

Cohorts 1, 1a, 1b, & 1c: Number of participants with Adverse Events as a measure of safety and tolerability

+1 more

Secondary study objectives

All Cohorts: Number of participants who achieve IFN-γ T-cell response at week 16 via ELISPOT assessments

Cohort 1d: Number of participants who are alive without progression at 11 months after surgery resection

Cohorts 1, 1a, 1b, & 1c: Number of participants who are alive without progression at eight months after surgery resection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Coh 1d: Std RT+TMZ Followed by 6 Cyc TMZ + NeoVax + PembroExperimental Treatment5 Interventions

• RT: Standard RT (60Gy) + concurrent daily temozolomide (TMZ) over 6 weeks. Concurrent TMZ @ 75 mg/m2/day for 6 weeks. Followed by: * 6 cycles of Adjuvant temozolomide (TMZ): Starts 4-6 weeks after completion of RT. TMZ (150-200 mg/m2/day) on days 1-5 of each 28-day cycle for 6 cycles. * Pembrolizumab: Starts 1-4 weeks after completion of NeoVax priming, and continues every 3 weeks for up to 2 years * NeoVax: Starts in the Adjuvant setting - as soon as available after RT - and is administered on days 1, 4, 8, 15, 22 \[priming doses\], 78 and 134 \[booster doses\] o NeoVax Day 1 does not have to coincide with Pembrolizumab dosing

Group II: Coh 1c: Std RT (+ 1 dose Pembro) Followed by NeoVax & PemboExperimental Treatment4 Interventions

* RT: Standard RT (60Gy) over 6 weeks * Pembrolizumab: Single dose of pembrolizumab administered within 2 weeks of start of RT; re-starts 1-4 weeks after completion of NeoVax priming, and continues every 3 weeks for up to 2 years. * NeoVax: Starts in the Adjuvant setting - as soon as available after RT - and is administered on days 1, 4, 8, 15, 22 \[priming doses\], 78 and 134 \[booster doses\] o NeoVax Day 1 does not have to coincide with Pembrolizumab dosing

Group III: Coh 1b: Std RT Followed by NeoVax + PembrolizumabExperimental Treatment4 Interventions

* RT: Standard RT (60Gy) over 6 weeks * Pembrolizumab: Starts 1-4 weeks after completion of NeoVax priming, and continues every 3 weeks for up to 2 years * NeoVax: Starts in the Adjuvant setting - as soon as available after RT - and is administered on days 1, 4, 8, 15, 22 \[priming doses\], 78 and 134 \[booster doses\] o NeoVax Day 1 does not have to coincide with Pembrolizumab dosing

Group IV: Coh 1a: Pembrolizumab w Std RT Followed by NeoVax + PembroExperimental Treatment4 Interventions

* RT: Standard RT (60Gy) over 6 weeks * Pembrolizumab: Starts within 2 weeks of start of RT, and continues every 3 weeks for up to 2 years * NeoVax: Starts in the Adjuvant setting - as soon as available after RT - and is administered on days 1, 4, 8, 15, 22 \[priming doses\], 78 and 134 \[booster doses\] o NeoVax Day 1 does not have to coincide with Pembrolizumab dosing

Group V: Coh 1 (Original Cohort): Standard RT Followed by NeoVaxExperimental Treatment3 Interventions

After the screening procedures confirm participant eligible to participate in the research study (must be registered to within 6 weeks of resection): * \~ 6 weeks of standard radiation therapy (RT) followed by an RT-recovery period. * During that time, participant NeoAntigen Vaccine-Preparation is created (process takes \~ 12 weeks) After participant recovers from RT and vaccine is created, participant will re-screen to confirm participant is eligible to receive study vaccinations. Once registered, participant will proceed to receive study vaccinations: - NeoAntigen Vaccine: NeoVax will be administered on an individual basis using a dosing schedule that incorporates both priming and boost phases (\~ 7 months total: 5 priming followed by 2 boost vaccine administrations)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Poly-ICLC

2016

Completed Phase 2

~300

Temozolomide

2010

Completed Phase 3

~1880