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Monoclonal Antibodies

Tremelimumab for Melanoma

Phase 1

Waitlist Available

Led By Patrick Ott, MD

Research Sponsored by F. Stephen Hodi, MD

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 2 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat metastatic melanoma.

Eligible Conditions

Metastatic Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of the maximum tolerated dose (MTD) of the combination of tremelimumab and MEDI3617

Secondary outcome measures

Disease Control Rate

Duration of Response

Overall Response Rate

+2 more

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407

38%

Fatigue

21%

Diarrhea

17%

Pruritus

17%

Maculopapular rash

17%

Anorexia

17%

Nausea

17%

Fever

14%

Rash maculo-papular

14%

Constipation

10%

Itching

10%

Anemia

10%

Abdominal pain

Cough

Dry Skin

Dehydration

Hypothyroidism

Non-cardiac chest pain

Weight loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab and Tremelimumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tremelimumab and MEDI3617Experimental Treatment2 Interventions

Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Tremelimumab-Fixed doses of Tremelimumab are given once per cycle MEDI3617-MEDI3617 is administered twice per cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tremelimumab

2017

Completed Phase 2

~3380

MEDI3617

2010

Completed Phase 1

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MedImmune LLCIndustry Sponsor

347 Previous Clinical Trials

793,894 Total Patients Enrolled

5 Trials studying Melanoma

289 Patients Enrolled for Melanoma

F. Stephen Hodi, MDLead Sponsor

Patrick Ott, MDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

19 Total Patients Enrolled

Frequently Asked Questions

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

Is this the pioneering trial of its type?

"Since 2007, Tremelimumab has been subject to a number of clinical trials. Initially sponsored by AstraZeneca and involving 37 participants in its first trial, the drug received Phase 2 approval shortly thereafter. Currently there are 91 studies actively running across 269 cities spanning 48 countries."

Answered by AI

What deleterious effects could arise from the use of Tremelimumab?

"Our experts scored tremelimumab's safety with a 1, as there is limited evidence supporting both its efficacy and security."

Answered by AI

How many participants can take part in this trial at one time?

"At this time, enrollment for the trial has been discontinued. The original posting was on May 1st 2014 and it ceased accepting participants after its last alteration on August 9th 2022. Patients seeking other studies may be interested in the 764 trials currently recruiting metastatic melanoma patients or 91 experiments that are looking to include people who receive tremelimumab therapy."

Answered by AI

Is enrollment currently open for this trial?

"According to clinicaltrials.gov, this trial is no longer in the recruitment phase; it was initially posted on May 1st 2014 and its most recent update took place on August 9th 2022. However, 855 other studies are still actively searching for participants at this time."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Combining CTLA-4 and Angiopoietin-2 Blockade in Patients with Advanced Melanoma: A Phase I Trial

Ott, Patrick A, Matthew Nazzaro, Kathleen L Pfaff, Evisa Gjini, Kristen D Felt, Jacquelyn O Wolff, Elizabeth I Buchbinder, et al.. 2021. “Combining CTLA-4 and Angiopoietin-2 Blockade in Patients with Advanced Melanoma: A Phase I Trial”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2021-003318.

clinicaltrials.govStudy

Phase I Clinical Trial of Tremelimumab Plus MEDI3617 in Patients With Unresectable Stage III or Stage IV Melanoma

F. Stephen Hodi, MD 2014. "Phase I Clinical Trial of Tremelimumab Plus MEDI3617 in Patients With Unresectable Stage III or Stage IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02141542.