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Checkpoint Inhibitor

Tremelimumab monotherapy for Bladder Cancer

Phase 2
Waitlist Available
Led By Sharma Padmanee, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy;
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 months in retreatment phase
Awards & highlights

Study Summary

This trial is testing tremelimumab, an immunotherapy drug, as a possible treatment for patients with advanced solid tumors.

Eligible Conditions
  • Bladder Cancer
  • Breast Cancer
  • Pancreatic Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with a solid tumor cancer, such as bladder cancer, metastatic pancreatic cancer, or triple negative breast cancer. You cannot tolerate, are not eligible for, or have declined the standard initial treatment for your cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12 months in retreatment phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 months in retreatment phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase
Secondary outcome measures
Best Objective Response (BoR) During Tremelimumab Monotherapy Phase
BoR During Retreatment Phase
DCR During Retreatment Phase
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: treme mono to be sequenced to MEDI4736 mono or combinationExperimental Treatment3 Interventions
tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab monotherapy
2015
Completed Phase 2
~70
MEDI4736 monotherapy
2015
Completed Phase 2
~130
MEDI4736 + tremelimumab combination therapy
2015
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,241 Previous Clinical Trials
288,522,076 Total Patients Enrolled
Sharma Padmanee, MD, PhDPrincipal InvestigatorAnderson Cancer Center, the University of Texas

Frequently Asked Questions

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

How does the efficacy of MEDI4736 + tremelimumab combination therapy compare to other treatments?

"The safety of MEDI4736 + tremelimumab combination therapy was rated as a 2. This is due to the fact that this is only a Phase 2 trial, so while there is some evidence supporting its safety, none exists for efficacy."

Answered by AI

Are there other examples of MEDI4736 + tremelimumab being used together to treat patients?

"There are a total of 345 ongoing clinical trials for MEDI4736 + tremelimumab combination therapy. Out of those, 51 have progressed to Phase 3 testing. Although the majority of research is based in Cordoba, Texas, there are 13051 locations running trials worldwide."

Answered by AI

Does this type of experiment with drugs happen often?

"The research and development of MEDI4736 + tremelimumab began in 2007. A clinical trial was conducted that same year and was sponsored by AstraZeneca. After the initial Phase 2 drug approval in 2007, which only involved 37 patients, there are now 345 live studies being conducted for this combination therapy across 1325 cities and 58 countries."

Answered by AI

Are adolescents eligible to participate in this research project?

"The age bracket for patients that this trial is looking to enroll starts at 18 years old and ends at 150 years old."

Answered by AI

Are there any volunteers still needed for this clinical trial?

"No, this particular trial is not recruiting patients at the moment according to its listing on clinicaltrials.gov. This information was last updated on November 8th, 2022. Although this study isn't looking for participants right now, there are 1848 other trials with open recruitment across a variety of medical fields."

Answered by AI

Could I potentially take part in this research?

"In order to qualify for this study, potential patients must have a diagnosis of urinary bladder cancer and meet the age criteria of being between 18-150 years old. Currently, the trial is looking to enroll a total of 64 individuals."

Answered by AI

What types of cancers does the MEDI4736 + tremelimumab combination therapy target?

"This combination therapy of MEDI4736 and tremelimumab is most often used to treat stage iii non-small cell lung cancer that cannot be removed through surgery. It can also be an effective treatment for metastatic ureter urothelial carcinoma and advance directives."

Answered by AI

How many people have been approached to participate in this research?

"Presently, this study is not recruiting patients. The trial was first posted on November 2nd, 2015 and was last updated on November 8th, 2022. However, there are 1503 clinical trials for urinary bladder cancer and 345 studies for the MEDI4736 + tremelimumab combination therapy that are actively searching for participants."

Answered by AI
~7 spots leftby Mar 2025