Pembrolizumab for Relapse

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, OH
Relapse+2 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called Pembrolizumab and a vaccine called SurVaxM can help treat people with recurrent glioblastoma.

See full description

Eligible Conditions

  • Relapse
  • Recurrent Glioblastoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome and 1 secondary outcome in patients with Relapse. Measurement will happen over the course of 6 months from start of treatment.

Month 6
Progression free survival (PFS)
Year 1
Safety and tolerability of Pembrolizumab and SurVaxM as measure by CTCAE v 5 grading as per NCI

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm B - Have failed prior anti-PD1 therapy
1 of 2
Arm A - Have not received immunotherapy
1 of 2
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm B - Have failed prior anti-PD1 therapyArm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Arm A - Have not received immunotherapyArm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montanide ISA 51
2003
Completed Phase 2
~140
Pembrolizumab
FDA approved
Sargramostim
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year from enrollment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 year from enrollment for reporting.

Closest Location

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Relapse or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug.
Previous treatment with anti PD1 will be allowed only in the exploratory arm
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archive tissue
Histologically confirmed diagnosis of World Health Organization Grade IV glioma (glioblastoma or gliosarcoma)
Previous first line treatment with at least radiotherapy with or without temozolomide
Documented first recurrence of GBM by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI) performed within 21 days of randomization per RANO criteria.
-- Histopathologic confirmation of recurrent tumor, or -- New enhancement on MRI outside of the radiotherapy treatment field
Karnofsky performance status of 70 or higher or ECOG 0-2
--Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.

Patient Q&A Section

What are common treatments for glioblastoma?

"A variety of treatments are used for GLI: surgery, chemotherapy, radiation, targeted drugs, and combinations thereof. These treatments are often used by many patients over different time frames." - Anonymous Online Contributor

Unverified Answer

How many people get glioblastoma a year in the United States?

"The American Cancer Society estimates 7,040 to 10,910 people will develop glioblastoma a year in the United States. This disease has a poor prognosis and occurs primarily in older men." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for glioblastoma?

"More work is needed to identify patient populations who would have a substantial benefit from clinical trial enrollment and to develop and implement clinical trial protocols. We recommend a clinical trial for children if there are familial members with glioblastoma (Gli2401." - Anonymous Online Contributor

Unverified Answer

Can glioblastoma be cured?

"The authors conclude that the data suggests that the glioblastoma may be cured with a single course of therapy. However, this may not be appropriate strategy in all subsets of patients, and may not be sufficient for a complete cure. Furthermore, the authors do not recommend a treatment that may be curative in all patients with glioblastoma in the absence of adverse event risks. The authors recommend a more tailored treatment plan based on clinical and imaging assessments and should not seek to cure patients with glioblastoma unless they are able to control adverse events with the therapy." - Anonymous Online Contributor

Unverified Answer

What is glioblastoma?

"Glioblastoma is a tumour in the brain. The tumour usually starts in children under 10 years old and often spreads out from the lining of the base of the brain to form a solid mass. The tumour may have a number of symptoms. Most children die 6 to 12 months after they are diagnosed.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of glioblastoma?

"Most tumors are slow to grow (average size about four cm) which may take between 6 years and almost 20 years to grow to the size of an average human brain. It is important for a person to pay special attention to symptoms, signs, and signs of a tumor that could be a sign of a tumor or malignant brain disease like glioblastoma. This information may help to choose how an individual can best manage their tumor as well as their chances of being cured or having a long-lived remission. The prognosis of a glial tumor depends on if it has grown to a large size with signs of compression (infiltration), is the glioma in a person's brain or spinal cord." - Anonymous Online Contributor

Unverified Answer

What causes glioblastoma?

"There are different factors which contribute to the initiation of glioma. This includes not only genetic factors but also environmental factors. Overall, the main risk factors are age, ionizing radiation and the exposure to alimentary and occupational carcinogens. Additionally, the interaction of more than one of these risk factors have also contributed to this malignancy. The genetic predisposition seems also strongly influence this malignancy, although it is debated. Smoking behaviour also influences the development of glioma. These are the biggest risk factors for the future development of the patient with a malignancy." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets glioblastoma?

"Glioblastoma is the most common malignant brain tumor in children and young adults. It is especially common in the developing world, particularly Africa, India, Bangladesh and the Middle East. However, it is not limited to these regions and also occurs in the Western world. Most often it is diagnosed in people under 30 years of age and is associated with a worse prognosis compared to other primary brain cancers. It is found in both sexes." - Anonymous Online Contributor

Unverified Answer

What is pembrolizumab?

"Pembrolizumab is an FDA-approved immunotherapy to treat a large panel of tumors and is the first-in-class anti-PD-1 antibody. In May 2014, it was prescribed for a patient with recurrent glioblastoma at UCSF Medical Center." - Anonymous Online Contributor

Unverified Answer

Is pembrolizumab safe for people?

"This analysis shows that PD-1 inhibitors are associated with very few adverse events. The most frequent were headache, fatigue and constipation. Serious infections are an infrequent but serious side effect of a PD-1 inhibitor. The data also show that treatment of people with PD-1 inhibitors in this population is not harmful and is not associated with any increased mortality." - Anonymous Online Contributor

Unverified Answer

How does pembrolizumab work?

"In conclusion, pembrolizumab worked as primary treatment in our patient with a combination of previous and progressive relapsing disease even after four years from first infusion. This demonstrates a similar efficacy to that reported with previous therapies. Our case reinforces the hypothesis of efficacy of anti-PD-1 agents in patients previously treated with several lines of chemotherapy, even for patients who are more advanced than our patient." - Anonymous Online Contributor

Unverified Answer

How quickly does glioblastoma spread?

"• In a recent study, findings indicates that patients with stage 4 glioblastoma have a similar overall survival rate as those with stage 3 glioblastoma. • We conclude that TKI treatment should not be withheld in patients with stage 4 glioblastoma who present to the ED with symptoms of elevated intraventricular pressure. • Larger prospective studies are needed to determine the optimal timing of surgery in patients with stage 3 glioblastoma who present with symptoms of elevated intracranial pressure." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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