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PD-L1 Inhibitor

MEDI1191 for Cancer

Phase 1
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of medi1191 through to 3.5 years after last dose of investigational product.
Awards & highlights

Study Summary

This trial is testing a new drug, MEDI1191, given directly into tumors, either alone or with the existing drug durvalumab, to see if it is effective against solid tumors.

Eligible Conditions
  • Solid Tumors
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of medi1191 through to 3.5 years after last dose of investigational product.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of medi1191 through to 3.5 years after last dose of investigational product. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with adverse events (AEs) serious adverse events (SAEs) and dose limiting toxicities (DLTs).
Objective response rate (ORR) in patients within expansion arms.
Secondary outcome measures
Area under the concentration-time curve (AUC) of MEDI1191
Clearance of MEDI1191
Disease Control Rate (DCR).
+8 more

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471
26%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: MEDI1191 expansion in combination with durvalumabExperimental Treatment2 Interventions
MEDI1191 expansion in concurrent combination with durvalumab
Group II: MEDI1191 escalation in combination with durvalumabExperimental Treatment2 Interventions
MEDI1191 escalation in sequential and concurrent combination with durvalumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI1191
2019
Completed Phase 1
~70
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,848 Total Patients Enrolled
MedImmune LCCStudy DirectorMedImmune LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the research team recruiting for this trial?

"This medical trial concluded its recruitment process. It was initially posted on May 8th 2019 and last updated on November 30th 2022. However, there are still 2998 trials actively enrolling those with malignancies and 333 studies accepting participants for MEDI1191 specifically."

Answered by AI

Do I meet the requirements to join this clinical experiment?

"This clinical trial is recruiting 61 patients aged 18 to 101 who have been diagnosed with malignancies. Additionally, there are strict prerequisites for enrollment including ECOG 0-1 status and adequate organ function within 2 weeks of receiving treatment. Participants must also cease using certain medications 7 days prior to the first dose of MEDI1191, provide histological or cytological confirmation of their condition, have progressed on at least one line of standard systemic therapy in the recurrent/metastatic setting., use an effective form contraception from screening through 3 months after receipting the final dose of investigational product (if applicable) , show evidence that they possess"

Answered by AI

How widespread is the administration of this trial?

"Presently, this trial has 7 different sites across the country. These include centres located in The Bronx, Newport Beach and La Jolla amongst other locations. It is paramount to select a clinic that offers convenient access for participants if you choose to join the study."

Answered by AI

Does this clinical experiment cater to individuals over the age of 45?

"This clinical trial is open to anyone between 18 and 101 years of age. There are 378 trials specifically for those under 18, while 3084 studies are targeting patients over the age of 65."

Answered by AI

What purpose is this clinical research aiming to fulfill?

"The primary outcome of the trial, which will be assessed within a 90 day period from initial informed consent, is Objective Response Rate (ORR) in patients receiving either MEDI1191 or Durvalumab. Secondary outcomes include Area Under Concentration-Time Curve (AUC), Maximum Observed Concentration (Cmax), and Progression Free Survival (PFS). PK endpoints for MEDI1191 and durvalumab concentrations in serum at multiple time points after administration are also under evaluation."

Answered by AI

Has MEDI1191 received clearance from the United States Food and Drug Administration?

"MEDI1191 was rated a 1 on our safety scale due to the initial Phase 1 trial, which provided limited evidence for both its efficacy and potential risks."

Answered by AI

What pathologies is MEDI1191 usually prescribed to address?

"MEDI1191 is an effective treatment option for individuals suffering from unresectable stage III non-small cell lung cancer, those with metastatic ureter urothelial carcinoma who have not received previous treatments and more."

Answered by AI

Are there any past experiments that have utilized MEDI1191?

"MEDI1191 first entered clinical trials in 2010 at City of Hope. Thus far, 106 studies have been completed and 333 are currently ongoing; the majority of these latter investigations take place within Bronx, New york."

Answered by AI

Are there any openings for participants in this experiment?

"This clinical trial is not presently selecting participants. It was first advertised on May 8th, 2019 and last modified November 30th of 2022. If you are interested in other trials, 2998 trials related to malignancies are currently enrolling patients while 333 studies concerning MEDI1191 have available openings for research subjects."

Answered by AI
~10 spots leftby Apr 2025