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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
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreTrial 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
3,656 Total Patients Enrolled
9 Trials studying Melanoma
2,645 Patients Enrolled for Melanoma
AstraZenecaIndustry Sponsor
4,286 Previous Clinical Trials
288,619,937 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a live vaccine for an infectious disease within the past 4 weeks before starting the study treatment.You are expected to live for at least 3 more months.You have tumors in your brain or spinal cord that are causing symptoms and have not been treated yet.You have taken steroids to treat cancer that has spread to your brain for more than 2 weeks before starting the study treatment.You have had serious allergic reactions to the medications used in the study before.You have a serious heart condition or your heart isn't working properly.You have a current autoimmune disease or have had one in the past.You have had lung problems in the past caused by previous treatments.It's okay if you have been using local steroids like eye drops, inhalers, or joint injections.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
- Group 3: Arm 5
- Group 4: Arm 4
- Group 5: Arm 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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