A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03889275 |
Recruitment Status :
Active, not recruiting
First Posted : March 26, 2019
Last Update Posted : August 15, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors | Biological: MEDI5395 Biological: Durvalumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors. |
Actual Study Start Date : | October 24, 2019 |
Actual Primary Completion Date : | November 19, 2021 |
Estimated Study Completion Date : | December 19, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Sequential
MEDI5395 and durvalumab administered sequentially
|
Biological: MEDI5395
Subjects will receive multiple doses of MEDI5395 over several days. Biological: Durvalumab Durvalumab will be administered periodically for a maximum of 2 years or until radiologically confirmed disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity
Other Name: Imfinzi |
Experimental: Concurrent
MEDI5395 and durvalumab administered concurrently
|
Biological: MEDI5395
Subjects will receive multiple doses of MEDI5395 over several days. Biological: Durvalumab Durvalumab will be administered periodically for a maximum of 2 years or until radiologically confirmed disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity
Other Name: Imfinzi |
- Number of subjects with adverse events (AEs) serious adverse events (SAEs) and dose limiting toxicities (DLTs). [ Time Frame: From the time of informed consent until 90 days after the last dose of investigational product (MEDI5395 or durvalumab) ]The occurrence of DLTs will be used to establish the maximum tolerated dose (MTD) of MEDI5395.
- Objective response rate (ORR) [ Time Frame: Estimated to be from the time of informed consent for approximately 2.5 years ]The ORR is defined as the proportion of subjects with confirmed response (CR) or confirmed partial response (PR).
- Disease Control Rate (DCR) [ Time Frame: Estimated to be from the time of informed consent for approximately 2.5 years ]The DCR will be estimated by the proportion of disease control. Disease control is defined as CR, PR or stable disease.
- Duration of Response (DoR) [ Time Frame: Estimated to be from the time of informed consent for approximately 2.5 years ]The DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
- Time To Response (TTR) [ Time Frame: Estimated to be from the time of informed consent for approximately 2.5 years ]The TTR is defined as the time from the start of treatment with any investigational product until the first documentation of a subsequently confirmed objective response.
- Progression Free Survival (PFS) [ Time Frame: Estimated to be from the time of informed consent for approximately 2.5 years ]PFS will be measured from the start of treatment with any investigational product until the first documentation of disease progression or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Estimated to be from the time of informed consent for approximately 2.5 years ]OS will be measured from the start of treatment with investigational product until death due to any cause.
- MEDI5395 viral genome copies in blood collected over time [ Time Frame: Estimated to be from the time of informed consent for approximately 6 months ]MEDI5395 concentrations in blood will be tabulated by dose cohort along with descriptive statistics.
- Granulocyte-macrophage colony-stimulating factor (GM-CSF) concentrations in blood collected over time [ Time Frame: Estimated to be from the time of informed consent for approximately 6 months ]GM-CSF protein concentrations in blood will be tabulated by dose cohort along with descriptive statistics.
- Number of subjects who develop detectable anti-MEDI5395 neutralizing antibodies [ Time Frame: Estimated to be from the time of informed consent until approximately 90 days after the last dose of last investigational product ]Immunogenic response to MEDI5395 will be assessed by summarizing the number of subjects who develop detectable anti-MEDI5395 neutralizing antibodies
- Percentage of subjects who develop detectable anti-MEDI5395 neutralizing antibodies [ Time Frame: Estimated to be from the time of informed consent until approximately 90 days after the last dose of last investigational product ]Immunogenic response to MEDI5395 will be assessed by summarizing the percentage of subjects who develop detectable anti-MEDI5395 neutralizing antibodies
- The number of cluster of differentiation 8 (CD8) positive cells and programmed death-ligand 1(PD-L1) expressing cells within biopsies will be assessed. [ Time Frame: Estimated to be from the time of informed consent until 4 weeks after the first dose of MEDI5395 ]CD8 T cell infiltration and PD-L1 expression in tumors pre and post dosing will be assessed using validated IHC assays.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 101 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- The subject must consent to take precautionary measures to prevent Newcastle Disease Virus (NDV) transmission to humans and birds
- Subjects 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 subjects are required to have had at least one prior line of treatment in the recurrent or metastatic setting
- Subjects 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 subjects must consent to provide tumor tissue for correlative studies
- ECOG performance status of 0 to 1
- Adequate organ function
- Use of highly effective contraception (females) or male condom plus spermicide (males)
Exclusion Criteria
- Rapidly progressing disease defined as a subject that cannot tolerate a break of at least 8 weeks from systemic anticancer therapy.
- Primary central nervous system (CNS) disease is excluded
- Subjects 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: Subjects 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 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
- Subjects 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 subject safety or study results.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889275
United States, Arizona | |
Research Site | |
Phoenix, Arizona, United States, 85054 | |
United States, California | |
Research Site | |
La Jolla, California, United States, 92093 | |
United States, Minnesota | |
Research Site | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Research Site | |
Buffalo, New York, United States, 14263 | |
Research Site | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Research Site | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Pennsylvania | |
Research Site | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Rhode Island | |
Research Site | |
Providence, Rhode Island, United States, 02903 | |
United Kingdom | |
Research Site | |
Leeds, United Kingdom, LS9 7TF | |
Research Site | |
London, United Kingdom, SW3 6JJ |
Study Director: | Medimmune LLC | MedImmune LLC |
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT03889275 |
Other Study ID Numbers: |
D6450C00001 |
First Posted: | March 26, 2019 Key Record Dates |
Last Update Posted: | August 15, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure |
Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
solid tumors immunotherapy oncolytic virus NDV-GMCSF |
Neoplasms Durvalumab Antineoplastic Agents, Immunological Antineoplastic Agents |