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Monoclonal Antibodies

Tebentafusp (IMCgp100) for Melanoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Immunocore Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Life expectancy of at least 3 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of tebentafusp (IMCgp100) as a single agent and in combination with durvalumab (MEDI4736) and/or tremelimumab in patients with metastatic cutaneous melanoma who have progressed on prior PD-1 inhibitors.

Eligible Conditions
  • Melanoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are expected to live for at least 3 more months.

Timeline

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
Phase 1b Number of dose-limiting toxicities
Phase 2b Objective Response Rate
Secondary outcome measures
Correlation of PD-L1 and gp100
Disease Control Rate
Duration of Response
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm 5Experimental Treatment1 Intervention
Tebentafusp (IMCgp100) (single agent) subcutaneous injection
Group II: Arm 4Experimental Treatment1 Intervention
Tebentafusp (IMCgp100) (single agent)
Group III: Arm 3Experimental Treatment3 Interventions
IV Tebentafusp (IMCgp100) with durvalumab (MEDI4736) and tremelimumab
Group IV: Arm 2Experimental Treatment2 Interventions
IV Tebentafusp (IMCgp100) with tremelimumab
Group V: Arm 1Experimental Treatment2 Interventions
IV Tebentafusp (IMCgp100) with durvalumab (MEDI4736)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tebentafusp (IMCgp100)
2015
Completed Phase 2
~120
tremelimumab
2013
Completed Phase 2
~1550
durvalumab
2017
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

Immunocore LtdLead Sponsor
13 Previous Clinical Trials
3,027 Total Patients Enrolled
9 Trials studying Melanoma
2,645 Patients Enrolled for Melanoma
AstraZenecaIndustry Sponsor
4,237 Previous Clinical Trials
288,449,562 Total Patients Enrolled
19 Trials studying Melanoma
2,595 Patients Enrolled for Melanoma
Mohammed Dar, MDStudy DirectorImmunocore Ltd
3 Previous Clinical Trials
913 Total Patients Enrolled
2 Trials studying Melanoma
838 Patients Enrolled for Melanoma

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02535078 — Phase 1 & 2
Melanoma Research Study Groups: Arm 1, Arm 2, Arm 5, Arm 4, Arm 3
Melanoma Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT02535078 — Phase 1 & 2
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02535078 — Phase 1 & 2

Frequently Asked Questions

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

What are the conditions that IMCgp100 is used to treat?

"IMCgp100 is not only useful in treating unresectable stage iii non-small cell lung cancer, but also in metastatic ureter urothelial carcinoma and other advanced directives."

Answered by AI

At how many sites is this research being conducted?

"Patients are being enrolled at 14 different centres across America, with 3 major locations being Washington University in St. Louis, Missouri, the University of Chicago in Illinois and Duke University Cancer Center in Durham, North carolina."

Answered by AI

Are there any positions available for participants in this research project?

"That is correct. The online information shows that this study, which was originally posted on November 1st, 2015, is still looking for patients. In total, they need 312 people to participate and there are 13 different recruitment sites."

Answered by AI

Could you please tell us if there is prior history with IMCgp100 in medical research?

"At the moment, there are 347 clinical trials underway for IMCgp100. 51 of these active studies are in their third phase. Most of the research being conducted for IMCgp100 is based out of Cordoba, Texas; however, there are a total 13136 locations running trials for this medication across the globe."

Answered by AI

How many individuals are participating in this clinical trial?

"In order to run this study, 312 individuals that meet the pre-determined inclusion criteria are required. Candidates can enrol at sites such as Washington University in St. Louis or University of Chicago."

Answered by AI

Is this the first time this type of experiment has been conducted?

"There are 347 ongoing studies involving IMCgp100 in 58 countries and 1334 cities. The first study, sponsored by AstraZeneca, completed Phase 2 drug approval in 2007 with 37 patients. Since then, 125 more trials have been completed."

Answered by AI
~12 spots leftby Mar 2025