← Back to Search

Checkpoint Inhibitor

Tremelimumab for Melanoma

Phase 1
Waitlist Available
Led By Mark H. O'Hara, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically or cytologically confirmed metastatic melanoma, metastatic non-small cell lung cancer, metastatic breast cancer, or metastatic pancreatic adenocarcinoma relapsed or refractory to therapy as outlined
Age greater than or equal to 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new combination of cancer treatments to see if it is safe and effective.

Who is the study for?
Adults with metastatic melanoma, lung, breast, or pancreatic cancers who have tried at least one line of therapy and are not responding well can join. They must be in good physical condition (ECOG 0-1), have tumors that can be measured and treated with radiation, and use effective birth control. People cannot participate if they've had certain vaccines recently, other active cancers, previous treatments that conflict with the trial's methods or any uncontrolled illnesses.Check my eligibility
What is being tested?
The study is testing a combination treatment for advanced cancer patients: hypofractionated radiotherapy along with two immunotherapy drugs called MEDI4736 and Tremelimumab. The goal is to find out the best way to combine these treatments safely and effectively.See study design
What are the potential side effects?
Possible side effects include typical reactions from radiotherapy like skin irritation and fatigue as well as immune-related issues such as inflammation in various organs due to MEDI4736 and Tremelimumab. Each patient may experience different side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has spread and does not respond to treatment anymore.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
My brain metastases are not causing any symptoms.
Select...
I am using effective birth control as a woman able to have children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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 Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment3 Interventions
Subjects will receive 20 mg/kg MEDI4736 and 1 mg/kg tremelimumab in combination every 4 weeks for 4 doses, followed by 10 mg/kg MEDI4736 monotherapy every 2 weeks for 18 doses. The total duration of therapy is 12 months. Cohort 2 tests 17 Gy x 1 fraction.
Group II: Cohort 1Experimental Treatment3 Interventions
Subjects will receive 20 mg/kg MEDI4736 and 1 mg/kg tremelimumab in combination every 4 weeks for 4 doses, followed by 10 mg/kg MEDI4736 monotherapy every 2 weeks for 18 doses. The total duration of therapy is 12 months. Cohort 1 tests 8 Gy x 3 fractions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
Not yet FDA approved
Radiotherapy
2017
Completed Phase 3
~2610
Durvalumab
FDA approved

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,042 Total Patients Enrolled
16 Trials studying Melanoma
871 Patients Enrolled for Melanoma
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,642 Total Patients Enrolled
17 Trials studying Melanoma
896 Patients Enrolled for Melanoma
Mark H. O'Hara, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine

Frequently Asked Questions

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

Are there any preceding studies that utilized Tremelimumab?

"Presently, 340 medical studies focusing on Tremelimumab are underway. Of those trials, 52 have reached Phase 3. Cordoba, Texas serves as the primary center for these experiments; however 13107 treatment centers around the world are testing its efficacy."

Answered by AI

Does this trial remain open to new participants?

"Unfortunately, no more recruits are being accepted for this trial. First posted on January 26th 2016 and last updated October 12th 2021, it is now closed to new applicants. However, those interested in other studies may want to consider the 3356 clinical trials recruiting participants with breast cancer or the 340 open Tremelimumab experiments."

Answered by AI

Has the FDA granted authorization for Tremelimumab's usage?

"The safety of tremelimumab is estimated to be at a level 1 due to this being an early phase trial, so there's only limited evidence on its efficacy and safety."

Answered by AI

How many individuals are actively taking part in this clinical investigation?

"This trial has ended its recruitment process. It was first posted on January 26th 2016 and the data was last updated on October 12th 2021. As an alternative, there are 3316 trials for breast cancer and 340 studies that use Tremelimumab currently recruiting patients."

Answered by AI

What therapeutic purpose is Tremelimumab most frequently employed for?

"Tremelimumab is the go-to treatment for most cases of unresectable stage III non-small cell lung cancer. This pharmaceutical has additionally been proven to be efficacious in managing metastatic ureter urothelial carcinoma and advanced directives."

Answered by AI

Is this the inaugural implementation of a clinical trial such as this?

"Since its inception in 2007, AstraZeneca has sponsored and conducted numerous studies on Tremelimumab. After the initial clinical trial of 37 participants, Phase 2 approval was granted for this drug. Currently there are 340 ongoing trials located in 1327 cities scattered across 58 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers
2016. "Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02639026.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top