A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors
NCT ID: NCT03889275
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2019-10-24
2022-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1A: MEDI5395 Dose Level 1 + Sequential Durvalumab
Participants will receive IV infusions of MEDI5395 Dose Level 1 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab every 4 weeks (Q4W) starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Cohort 2A: MEDI5395 Dose Level 2 + Sequential Durvalumab
Participants will receive IV infusions of MEDI5395 Dose Level 2 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Cohort 3A: MEDI5395 Dose Level 3 + Sequential Durvalumab
Participants will receive IV infusions of MEDI5395 Dose Level 3 on Days 1, 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Cohort 3A Backfill: MEDI5395 Dose Level 3 + Sequential Durvalumab
Participants will receive IV infusions of MEDI5395 Dose Level 2 on Day 1 and Dose Level 3 on Days 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Cohort 4A: MEDI5395 Dose Level 4 + Sequential Durvalumab
Participants will receive IV infusions of MEDI5395 Dose Level 2 on Day 1 and Dose Level 4 on Days 4, 8, 10, 12, and 15 followed by durvalumab Q4W starting from 14 days after the last dose of MEDI5395 for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Cohort 1B: MEDI5395 Dose Level 1 + Concurrent Durvalumab
Participants will receive IV infusions of MEDI5395 Dose Level 1 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Cohort 2B: MEDI5395 Dose Level 2 + Concurrent Durvalumab
Participants will receive IV infusions of MEDI5395 Dose Level 2 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Cohort 3B: MEDI5395 Dose Level 3 + Concurrent Durvalumab
Participants will receive IV infusions of MEDI5395 Dose Level 3 on Days 1, 4, 8, 10, 12, and 15 and durvalumab Q4W, starting from the same day as third dose of MEDI5395, for maximum of 2 years or until disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity; whichever occurs first.
MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Interventions
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MEDI5395
Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have histologic documentation of advanced solid tumor and received and have progressed, are refractory, or are intolerant to standard therapy for the specific tumor type. All participants are required to have had at least one prior line of treatment in the recurrent or metastatic setting
* Participants must have at least 1 measurable lesion and an additional non-lymph node non-target lesion that can be biopsied at acceptable risk as judged by the investigator. (Note: if a non-target lesion is not available or cannot be biopsied, a RECIST target, non-lymph node lesion, lesion \>= 2 cm in longest diameter may be used for non-excisional biopsy
* All participants must consent to provide tumor tissue for correlative studies
* The ECOG performance status of 0 to 1
* Adequate organ function
* Use of highly effective contraception (females) or male condom plus spermicide (males)
Exclusion Criteria
* Primary central nervous system (CNS) disease is excluded
* Participants who have received prior check point inhibitor immunotherapy within 28 days and/or oncolytic virus therapy within 90 days prior to the first dose of MEDI5395
* Unresolved toxicities from prior anticancer therapy that led to permanent discontinuation of prior immunotherapy or that required immunosuppression other than corticosteroids
* History of severe allergic reactions to any of the study drug components
* Infectious disease exclusions including tuberculosis, Human immunodeficiency virus (HIV), hepatitis A, B or C, active bacterial, fungal or viral infections plus receipt of live attenuated vaccine prior to first dose of MEDI5395. (NOTE: Participants with evidence of fully recovered past hepatitis B infection who developed immunity OR hepatitis B/C with undetectable virus load and are on medications may be permitted).
* Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic test at screening
* Any conditions requiring use of any systemic immunosuppressant including systemic corticosteroids, methotrexate, azathioprine, tumor necrosis factor (TNF) inhibitor, and/or interleukin 6 (IL-6) blockers
* Active autoimmune disease or chronic inflammatory condition (Exceptions include vitiligo, alopecia, hypothyroidism on stable treatment, diverticulosis, controlled celiac disease, and chronic skin conditions not requiring systemic therapy)
* Active acquired immune-deficiency states
* Participants who are regularly exposed to poultry or birds
* Current active hepatitis or biliary disease (except for Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease)
* Clinically significant pulmonary disease and cardiac disease
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
18 Years
101 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medimmune LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
La Jolla, California, United States
Research Site
Rochester, Minnesota, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Providence, Rhode Island, United States
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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Davar D, Carneiro BA, Dy GK, Sheth S, Borad MJ, Harrington KJ, Patel SP, Galanis E, Samson A, Agrawal S, Chen Z, Fan C, Gong M, Burton J, Tu E, Durham N, Laubscher K, Arnaldez F, Zamarin D. Phase I study of a recombinant attenuated oncolytic virus, MEDI5395 (NDV-GM-CSF), administered systemically in combination with durvalumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Nov 17;12(11):e009336. doi: 10.1136/jitc-2024-009336.
Related Links
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Other Identifiers
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D6450C00001
Identifier Type: -
Identifier Source: org_study_id
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