CompletedNCT03946800Updated Oct 2, 2024

A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors

A Phase 1 interventional study of MEDI1191 and Durvalumab in Solid Tumors and Cancer, sponsored by MedImmune LLC. Completed at 11 sites in 2 countries. Open to participants aged 18 Years to 101 Years. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by MedImmune LLC · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Aug 2023, 3 years 1 month ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 61
Allocation: Non-randomized
Ages: 18 Years to 101 Years
Sex: All

Study summary

To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination with intravenous durvalumab in patients with solid tumors.

Read the detailed description

This is a multicenter, open-label study to evaluate MEDI1191 delivered by intratumoral injection in sequential and concurrent combination with intravenous durvalumab to subjects with solid tumors. The study has a dose escalation design using mTPI-2 to evaluate a range of doses.

Conditions studied

Solid Tumors
Cancer

Browse trials for

Neoplasms 9,365

Keywords

MEDI1191
Durvalumab
MEDI4736
Imfinzi

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 61 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 101 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 7 days prior to the first dose of study treatment. For subjects who have received prior immunotherapy, the following additional exclusion criteria apply:
1. Received only one dose of prior immunotherapy agent alone or as part of a combination regimen
2. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy
3. All AEs while receiving prior immunotherapy did not resolve to ≤ Grade 1 or baseline prior to screening for this study.
4. Experienced a ≥ Grade 3 AE (including pneumonitis) or neurologic, ocular, or cardiac AE of any grade while receiving prior immunotherapy.
5. 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.
Cardiac exclusions: New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled hypertension, acute coronary syndrome within 6 months.
Any condition that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Uncontrolled intercurrent illness.
Untreated, active hepatitis B or C.
Major surgery within 4 weeks prior to first dose of MEDI1191 or still recovering from prior surgery.
Subjects with untreated active major depression with suicidal ideation and/or plan.
Female subjects who are pregnant, lactating, or intend to become pregnant during their participation in this study.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 61 participants (actual)

Study arms

Experimental
MEDI1191 escalation in combination with durvalumab
MEDI1191 escalation in sequential and concurrent combination with durvalumab
Biological: MEDI1191 · Biological: Durvalumab
Experimental
MEDI1191 expansion in combination with durvalumab
MEDI1191 expansion in concurrent combination with durvalumab
Biological: MEDI1191 · Biological: Durvalumab

Interventions

BiologicalMEDI1191
Subjects will receive MEDI1191 (at least twice)
BiologicalDurvalumab
Subject will receive durvalumab every 4 weeks

What researchers measure

Primary outcomes

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.
Time frame: 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).
Time frame: Estimated to be from time of informed consent up to 3.5 years.

Secondary outcomes

Number of advanced solid tumor 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.
Time frame: 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.
The ORR is defined as the proportion of subjects with confirmed response (CR) or confirmed partial response (PR).
Time frame: Estimated to be from time of informed consent up to 3.5 years.
Disease Control Rate (DCR).
The DCR will be estimated by the proportion of disease control. Disease control is defined as CR, PR or stable disease.
Time frame: Estimated to be from time of informed consent up to 3.5 years.
Duration of Response (DoR).
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 frame: Estimated to be from time of informed consent up to 3.5 years.
Time To Response (TTR).
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.
Time frame: Estimated to be from time of informed consent up to 3.5 years .
Progression Free Survival (PFS).
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.
Time frame: Estimated to be from time of informed consent up to 3.5 years.
Overall Survival (OS).
OS will be measured from the start of treatment with investigational product until death due to any cause.
Time frame: Estimated to be from time of informed consent up to 3.5 years.
Maximum observed concentration (Cmax) of MEDI1191 and durvalumab
The endpoints for assessment of PK of MEDI1191 and durvalumab include individual MEDI1191 and durvalumab concentrations in serum at different timepoints after administration.
Time frame: From first dose of MEDI1191 through to 30 days after last dose of investigational product.
Area under the concentration-time curve (AUC) of MEDI1191
The endpoints for assessment of PK of MEDI1191 include MEDI1191 concentrations in serum at different timepoints after administration.
Time frame: From first dose of MEDI1191 through to 30 days after last dose of investigational product.
Clearance of MEDI1191
The endpoints for assessment of PK of MEDI1191 include MEDI1191 concentrations in serum at different timepoints after administration.
Time frame: From first dose of MEDI1191 through to 30 days after last dose of investigational product.
Immunogenicity of MEDI1191
The endpoints for assessment of immunogenicity of MEDI1191 include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
Time frame: From first dose of MEDI1191 through to 3.5 years after last dose of investigational product.

Study locations

11 sites

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
Bronx, New York 10461, United States
Research Site
New York, New York 10029, United States
Research Site
New York, New York 10065, 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

References and documents

Individual participant data

Plan to share: Yes — 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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03946800
Lead sponsor: MedImmune LLC
Responsible party: Sponsor
First posted: May 13, 2019
Start date: May 8, 2019
Primary completion: Aug 24, 2023
Completion: Aug 24, 2023
Last update: Oct 2, 2024

Study contacts

MedImmune LCC

study director · MedImmune LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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