Condition or disease | Intervention/treatment | Phase |
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Malignant Glioma | Biological: PVSRIPO Drug: Atezolizumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b/2 Trial of PVSRIPO in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma |
Estimated Study Start Date : | February 2020 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | January 2024 |
Arm | Intervention/treatment |
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Experimental: PVSRIPO + Atezolizumab
Single PVSRIPO infusion at a dose of 5x10^7 tissue culture infected dose (TCID50). Atezolizumab infusions at a dose of 1200 mg every three weeks for up to two years.
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Biological: PVSRIPO
Oncolytic polio/rhinovirus recombinant
Drug: Atezolizumab Antibody
Other Name: Tecentriq
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient or partner(s) meets one of the following criteria:
Exclusion Criteria:
Patients with severe, active co-morbidity, defined as follow:
Patients who have not completed all standard of care treatments for recurrent glioma, including surgical procedure and radiation therapy (at least 59 Gy)
NOTE: If a patient is treated for an unrelated malignancy other than the exceptions noted within the past 3 years, a letter from their treating oncologist for the unrelated malignancy must be on file confirming that said unrelated malignancy does not require current active treatment (prophylactic like tamoxifen OK) and that the patient is stable with low risk of recurrence/death within 3 years from this other malignancy (i.e., disease is stable). If this letter is not on file, a consult with the Sponsor's medical designee is required prior to submitting the patient for consideration of enrollment in the trial.
Study Director: | Darell D Bigner, MD, PhD | Istari Oncology, Inc. | |
Principal Investigator: | Dina M Randazzo, DO | Duke University |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 31, 2019 | ||||||
First Posted Date ICMJE | June 4, 2019 | ||||||
Last Update Posted Date | February 11, 2020 | ||||||
Estimated Study Start Date ICMJE | February 2020 | ||||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma | ||||||
Official Title ICMJE | A Phase 1b/2 Trial of PVSRIPO in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma | ||||||
Brief Summary | This study evaluates the safety of PVSRIPO treatment in combination with Atezolizumab in patients with WHO grade IV malignant glioma. All patients will receive a single PVSRIPO infusion followed by atezolizumab infusions every three weeks for up to two years. | ||||||
Detailed Description | The purpose of this phase1b/2 study of atezolizumab in combination with oncolytic polio/rhinovirus recombinant (PVSRIPO) in patients with recurrent World Health Organization (WHO) grade IV malignant glioma is to assess the safety of the combination of PVSRIPO + atezolizumab, as well as describe the survival of patients receiving this novel therapy combination. Patients will receive an intratumoral infusion of PVSRIPO followed by atezolizumab treatment with possible surgical resection after the first atezolizumab treatment at the discretion of the treating neurosurgeon. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Malignant Glioma | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: PVSRIPO + Atezolizumab
Single PVSRIPO infusion at a dose of 5x10^7 tissue culture infected dose (TCID50). Atezolizumab infusions at a dose of 1200 mg every three weeks for up to two years.
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Withdrawn | ||||||
Actual Enrollment ICMJE |
0 | ||||||
Original Estimated Enrollment ICMJE |
31 | ||||||
Estimated Study Completion Date ICMJE | January 2024 | ||||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
NOTE: If a patient is treated for an unrelated malignancy other than the exceptions noted within the past 3 years, a letter from their treating oncologist for the unrelated malignancy must be on file confirming that said unrelated malignancy does not require current active treatment (prophylactic like tamoxifen OK) and that the patient is stable with low risk of recurrence/death within 3 years from this other malignancy (i.e., disease is stable). If this letter is not on file, a consult with the Sponsor's medical designee is required prior to submitting the patient for consideration of enrollment in the trial. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | United States | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03973879 | ||||||
Other Study ID Numbers ICMJE | Pro00100677 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Darell Bigner, Duke University | ||||||
Study Sponsor ICMJE | Darell Bigner | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Duke University | ||||||
Verification Date | February 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |