A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors
A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination With Durvalumab in Subjects With Advanced Solid Tumors
2 other identifiers
interventional
61
2 countries
11
Brief Summary
To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination with intravenous durvalumab in patients with solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2019
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedStudy Start
First participant enrolled
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2023
CompletedOctober 2, 2024
September 1, 2024
4.3 years
May 6, 2019
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of subjects with adverse events (AEs) serious adverse events (SAEs) and dose limiting toxicities (DLTs).
The occurrence of DLTs will be used to establish the maximum tolerated dose (MTD) of MEDI1191.
From time of informed consent until 90 days after the last dose of investigational product (MEDI1191 or durvalumab).
Objective response rate (ORR) in patients within expansion arms.
The ORR is defined as the proportion of subjects with confirmed response (CR) or confirmed partial response (PR).
Estimated to be from time of informed consent up to 3.5 years.
Secondary Outcomes (11)
Number of advanced solid tumor subjects with adverse events (AEs) serious adverse events (SAEs) and dose limiting toxicities (DLTs).
From time of informed consent until 90 days after the last dose of investigational product (MEDI1191 or durvalumab).
Objective response rate (ORR) in advanced solid tumor subjects.
Estimated to be from time of informed consent up to 3.5 years.
Disease Control Rate (DCR).
Estimated to be from time of informed consent up to 3.5 years.
Duration of Response (DoR).
Estimated to be from time of informed consent up to 3.5 years.
Time To Response (TTR).
Estimated to be from time of informed consent up to 3.5 years .
- +6 more secondary outcomes
Study Arms (2)
MEDI1191 escalation in combination with durvalumab
EXPERIMENTALMEDI1191 escalation in sequential and concurrent combination with durvalumab
MEDI1191 expansion in combination with durvalumab
EXPERIMENTALMEDI1191 expansion in concurrent combination with durvalumab
Interventions
Subjects will receive MEDI1191 (at least twice)
Subject will receive durvalumab every 4 weeks
Eligibility Criteria
You may qualify if:
- ECOG 0 to 1.
- Adequate organ function within 2 weeks of starting study treatment.
- Prior to the first dose of MEDI1191, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic.
- Cessation of systemic corticosteroids at doses exceeding 12 mg/day prednisone or equivalent, methotrexate, azathioprine, ustekinumab (Stelara®), and tumor necrosis factor (TNF)-α/IL-6 blockers for at least 7 days prior to the first dose of MEDI1191.
- Subjects must have at least one lesion suitable for intratumoral dosing for superficial lesions but at least two lesion suitable for intratumoral dosing for deep-seated lesions.
- Subjects must have at least one non-injected lesion that can be measured by RECIST v1.1.
- Histologic or cytologic confirmation of advanced solid tumor.
- Received and have progressed on or refractory to at least 1 line of standard systemic therapy in the recurrent/metastatic setting.
- Highly effective method of contraception from screening, and must agree to continue using such precautions for 3 months after the final dose of investigational product.
- Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 through 3 months after receipt of the final dose of investigational product.
You may not qualify if:
- Subjects who have received prior IL-12 either alone or as part of a treatment regimen.
- Subjects who were administered any live attenuated vaccines within 30 days prior to first MEDI1191 injection.
- Known allergy or hypersensitivity to any component of MEDI1191 or durvalumab formulations.
- Active or prior documented autoimmune disorders within the past 5 years prior to the first scheduled dose of study treatment except alopecia, hypothyroidism (stable of hormone replacement), chronic skin condition (does not require systemic therapy), and celiac disease (controlled by diet alone).
- Immune-deficiency states - myelodysplastic disorders, marrow failure states, human immunodeficiency virus infection, history of solid organ transplant, bone marrow allograft, or active tuberculosis.
- History of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
- Require continuous anticoagulation or antiplatelet therapy (except for ≤ 100 mg acetylsalicylic acid \[ASA\]) which cannot be interrupted for more than 7 days for IT delivery of MEDI1191.
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer.
- Received only one dose of prior immunotherapy agent alone or as part of a combination regimen
- Experienced a toxicity that led to permanent discontinuation of prior immunotherapy
- All AEs while receiving prior immunotherapy did not resolve to ≤ Grade 1 or baseline prior to screening for this study.
- Experienced a ≥ Grade 3 AE (including pneumonitis) or neurologic, ocular, or cardiac AE of any grade while receiving prior immunotherapy.
- Required the use of additional immunosuppression other than corticosteroids for the management of an AE, or experienced recurrence of an AE if re-challenged, or is currently requiring a maintenance dose of \> 12 mg prednisone or equivalent per day.
- Any toxicity from prior therapy that has not completely resolved to ≤ Grade 1 or baseline at the time of consent.
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI1191, except intranasal, topical, inhaled corticosteroids, local steroid injections, systemic corticosteroids at physiologic doses not to exceed 12 mg/day of prednisone or equivalent, or steroids as premedication for hypersensitivity reactions.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (11)
Research Site
La Jolla, California, 92093, United States
Research Site
Los Angeles, California, 90025, United States
Research Site
Los Angeles, California, 90089, United States
Research Site
New York, New York, 10029, United States
Research Site
New York, New York, 10065, United States
Research Site
The Bronx, New York, 10461, United States
Research Site
Providence, Rhode Island, 02903, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Barcelona, 08035, Spain
Research Site
Madrid, 28027, Spain
Research Site
Pamplona, 31008, Spain
Related Links
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
MedImmune LCC
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 13, 2019
Study Start
May 8, 2019
Primary Completion
August 24, 2023
Study Completion
August 24, 2023
Last Updated
October 2, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- 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.
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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.