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Checkpoint Inhibitor

Immunotherapy for Brain Cancer

Phase 1

Waitlist Available

Led By Patrick Wen, 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

Have a Karnofsky performance status (KPS) ≥ 70 (Appendix A).

Be at first or second relapse. Note: Relapse is defined as progression following initial therapy (i.e., radiation ± chemotherapy). For participants who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapse.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks. til density is determined in surgical tumor tissue; on-study surgery occurs 14 days (+/- 5 days) after neoadjuvant day 1.

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating a new type of treatment called immunotherapy for Glioblastoma, a type of brain cancer.

Who is the study for?

This trial is for adults with Grade IV malignant glioma (glioblastoma or gliosarcoma) who have undergone initial treatment and are at their first or second relapse. Participants must be over 18, able to consent, have a performance status indicating they can carry out daily activities, and show tumor progression on scans. They should also have normal organ function as defined by the study's criteria.

What is being tested?

The trial is testing Pembrolizumab (MK-3475), an immunotherapy drug, in patients with recurrent/progressive Glioblastoma that can be accessed surgically. It aims to understand how this drug affects early immune responses against the tumor.

What are the potential side effects?

Pembrolizumab may cause side effects such as fatigue, skin reactions, diarrhea, liver inflammation, hormone gland problems like thyroid disorders, and could potentially worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself.

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My cancer has returned once or twice after treatment.

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I have received radiotherapy as my first treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks. cell cycle/cancer proliferation genetic signature is determined in surgical tumor tissue; on-study surgery occurs 14 days (+/- 5 days) after neoadjuvant day 1.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks. cell cycle/cancer proliferation genetic signature is determined in surgical tumor tissue; on-study surgery occurs 14 days (+/- 5 days) after neoadjuvant day 1.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks. cell cycle/cancer proliferation genetic signature is determined in surgical tumor tissue; on-study surgery occurs 14 days (+/- 5 days) after neoadjuvant day 1. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cell Cycle and Cancer Proliferation Genetic Signature

Incidence of Treatment-Emergent Adverse Events

Lymphocyte

Secondary study objectives

Progression Free Survival (PFS)

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468

40%

FATIGUE

37%

INFUSION RELATED REACTION

37%

NAUSEA

23%

ANOREXIA

23%

DIARRHEA

23%

BACK PAIN

23%

ABDOMINAL PAIN

20%

ARTHRALGIA

20%

NON-CARDIAC CHEST PAIN

20%

COUGH

17%

MYALGIA

17%

CONSTIPATION

17%

DYSPNEA

17%

CHILLS

13%

HEADACHE

13%

RASH MACULO-PAPULAR

13%

DIZZINESS

13%

PRURITUS

10%

LUNG INFECTION

10%

SINUS TACHYCARDIA

10%

ALLERGIC REACTION

10%

ANXIETY

10%

ANEMIA

10%

SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY

10%

URTICARIA

10%

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY

10%

EDEMA LIMBS

DEPRESSION

FLU LIKE SYMPTOMS

HYPONATREMIA

URINARY TRACT INFECTION

FLUSHING

HYPERTHYROIDISM

VOICE ALTERATION

PLEURAL EFFUSION

HYPERGLYCEMIA

DYSPEPSIA

PAIN

LYMPHOCYTE COUNT DECREASED

VOMITING

FEVER

FLATULENCE

CREATININE INCREASED

NECK PAIN

PRODUCTIVE COUGH

EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY

PELVIC PAIN

TUMOR PAIN

HYPOTHYROIDISM

HEMORRHOIDS

TREMOR

ESOPHAGITIS

CONJUNCTIVITIS

DEHYDRATION

GAIT DISTURBANCE

BLURRED VISION

INSOMNIA

BLOATING

PRESYNCOPE

PARESTHESIA

DRY MOUTH

GASTROESOPHAGEAL REFLUX DISEASE

SORE THROAT

BRONCHOSPASM

HYPOMAGNESEMIA

MOVEMENTS INVOLUNTARY

PERIPHERAL MOTOR NEUROPATHY

ACUTE KIDNEY INJURY

NASAL CONGESTION

PAIN OF SKIN

PNEUMONITIS

DRY SKIN

FLASHING LIGHTS

HYPOTENSION

SINUSITIS

HEARING IMPAIRED

MALAISE

ALKALINE PHOSPHATASE INCREASED

OSTEONECROSIS OF JAW

NEUTROPHIL COUNT DECREASED

THROMBOEMBOLIC EVENT

RASH ACNEIFORM

SOMNOLENCE

HYPERTENSION

MUSCLE WEAKNESS LOWER LIMB

SYNCOPE

VAGINAL INFECTION

PAIN IN EXTREMITY

DYSPHAGIA

POSTNASAL DRIP

COLITIS

HOT FLASHES

RESPIRATORY FAILURE

GASTROINTESTINAL DISORDERS - OTHER, SPECIFY

ALLERGIC RHINITIS

SEPSIS

WEIGHT GAIN

100%

80%

60%

40%

20%

Study treatment Arm

Imprime PGG 4 mg/kg

Imprime PGG 2 mg/kg

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pre-surgery MK-3475Experimental Treatment1 Intervention

-After a screening phase of 14 days, eligible subjects will be randomized into two groups. * Pembrolizumab (MK3475) pre-surgery at pre-determine dosage followed by Pembrolizumab at pre-determine dosage every 3 weeks post surgery. * MK-3475 will be administered intravenously

Group II: No MK-3475 at Pre-SurgeryActive Control1 Intervention

-After a screening phase of 14 days, eligible subjects will be randomized into two groups. * Pembrolizumab (MK-3475) at pre-determine dosage every 3 weeks post surgery. * MK-3475 will be administered intravenously

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-3475

2014

Completed Phase 2

~1350

0 / 3Eligibility criteria met