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Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

Study Purpose

The purpose of the study is to characterize the safety and tolerability of avelumab in combination with Laser Interstitial Thermal Therapy (LITT) for blood barrier disruption in patients with recurrent glioblastoma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must have histologically proven GBM from the initial resection.
  • - Patients must have a life expectancy > 16 weeks.
Patients must have a Karnofsky performance status of ≥ 60 or ECOG 0
  • - 2.
  • - Patient's requirement for dexamethasone should be ≤ 4mg daily or a stable dose at enrollment.
  • - Patients must have adequate bone marrow, hepatic and renal function and hemoglobin and the test musts be performed within 14 days prior to study Day 1.
  • - Highly effective contraception for both male and female subjects if the risk of conception exists.

Exclusion Criteria:

  • - Known history of autoimmune disorder except diabetes mellitus type 1, vitiligo or hypothyroidism only requiring hormone replacement.
  • - Patients who have received any other therapeutic investigational agent within 30 days of enrollment with the exception of the personalized MTA vaccine (NCT03223103) that can be continued throughout the study.
  • - Patients who have received any other therapeutic investigational agent within 30 days of enrollment or prior.
  • - Prior placement of intracavitary BCNU-impregnated wafers (Gliadel).
  • - Prior treatment with checkpoint inhibitors, CTL-4 antibody or other immunotherapy agents.
  • - Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment.
  • - Prior organ transplantation, including allogeneic stem cell transplantation.
  • - Significant acute or chronic infections including, among others: HIV, AIDS, HBV.
  • - Pregnancy or lactation.
Contact site for full inclusion/exclusion list.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03341806
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Icahn School of Medicine at Mount Sinai
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Adilia Hormigo, MD, PhD
Principal Investigator Affiliation Icahn School of Medicine at Mount Sinai
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, GBM
Additional Details

This is an open label, non-randomized Phase I study of intravenous avelumab every 2 weeks to be administered after real-time MRI-guided LITT therapy for patients with a first recurrence of a glioblastoma. The primary objective of the study is to characterize the tolerability and safety profile of avelumab in combination with MRI guided LITT administered to patients diagnosed with recurrent GBM. Part A, the initial cohort of patients will be treated with intravenous avelumab alone. Part B, patients will receive avelumab in combination with MRI-guided LITT to characterize the tolerability and safety of the combined treatment.

Arms & Interventions

Arms

Experimental: Patients with Recurrent Glioblastoma

Part A - Avelumab Part B - Avelumab + MRI-guided LITT therapy

Interventions

Drug: - Avelumab

Avelumab will be administered intravenously every 2 weeks at a dose of 10 mg/kg for 2 cycles

Combination Product: - MRI-guided LITT therapy

(Part B) prior to receiving Avelumab 10 mg/kg every 2 weeks + LITT

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

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