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Monoclonal Antibodies

IMCgp100 for Uveal 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 up to 49 months
Awards & highlights

Study Summary

This trial is testing a new weekly dose regimen for a single agent, IMCgp100, in patients with metastatic uveal melanoma. The goal is to identify the maximum tolerated dose and recommended Phase II dose.

Eligible Conditions
  • Uveal Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 49 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 49 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 Participants With a Dose Limiting Toxicity (DLT) in Phase 1
Objective Response Rate in Phase 2
Secondary outcome measures
Apparent Terminal Plasma Half-life (t½) of Tebentafusp
Area Under the Plasma Concentration-Time Curve (AUC) of Tebentafusp
Disease Control Rate
+10 more

Side effects data

From 2022 Phase 1 & 2 trial • 146 Patients • NCT02570308
81%
Pyrexia
69%
Pruritus
68%
Nausea
66%
Chills
61%
Fatigue
42%
Hypotension
41%
Vomiting
41%
Dry skin
40%
Rash maculo-papular
35%
Edema peripheral
35%
Abdominal pain
33%
Headache
33%
Rash
32%
Back pain
27%
Periorbital edema
27%
Hair color changes
26%
Arthralgia
26%
Diarrhea
25%
Decreased appetite
24%
Constipation
24%
Rash generalized
23%
Cough
22%
Skin exfoliation
20%
Skin hypopigmentation
20%
Abdominal pain upper
19%
Dyspnea
18%
Myalgia
18%
Influenza like illness
18%
Aspartate aminotransferase increased
17%
Skin hyperpigmentation
17%
Dizziness
17%
Erythema
17%
Pruritus generalized
16%
Weight decreased
16%
Insomnia
16%
Generalized erythema
15%
Alanine aminotransferase increased
15%
Pain in extremity
14%
Hypertension
13%
Anemia
13%
Gastroesophageal reflux disease
13%
Flushing
13%
Urinary tract infection
12%
Tachycardia
12%
Face edema
12%
Dyspepsia
11%
Hypophosphatemia
11%
Hot flush
11%
Hypokalemia
11%
Abdominal distension
10%
Blood alklaline phosphatase increased
10%
Nasopharyngitis
10%
Anxiety
10%
Hypomagnesemia
10%
Oropharyngeal pain
9%
Sinus tachycardia
9%
Upper respiratory tract infection
9%
Musculoskeletal pain
9%
Lipase increased
9%
Dysgeusia
9%
Alopecia
9%
Night sweats
9%
Skin mass
9%
Neck pain
8%
Hyperbilirubinemia
8%
Paresthesia
8%
Cytokine release syndrome
8%
Hypocalcemia
8%
Nasal congestion
8%
Pain
7%
Asthenia
7%
Dry eye
7%
Malaise
6%
Amylase increased
6%
Peripheral sensory neuropathy
6%
Procedural pain
6%
Sinusitis
6%
Tumor pain
6%
Confusional state
6%
Generalized edema
6%
Rhinorrhea
6%
Hepatic pain
6%
Dermatitis acneiform
6%
Vitiligo
6%
Fall
5%
Gastritis
5%
Depression
5%
Skin lesion
5%
Vision blurred
5%
Musculoskeletal chest pain
5%
Rash erythematous
4%
Skin abrasion
4%
Hypoalbuminemia
4%
Dehydration
4%
Muscular weakness
4%
Rash pruritic
4%
Contusion
3%
Non-cardiac chest pain
3%
Flank pain
3%
Hypoxia
3%
Lymphopenia
3%
Lacrimation increased
3%
Dry mouth
3%
Blood creatinine increased
3%
Hyperkalemia
3%
Hyperhidrosis
2%
Upper-airway cough syndrome
2%
Dermal cyst
2%
Dermatitis allergic
2%
Atrial flutter
2%
Vertigo
2%
Palpitations
2%
Syncope
2%
Visual impairment
2%
Facial pain
2%
Skin laceration
2%
Sunburn
2%
Hypermagnesemia
2%
Hypoglycemia
2%
Neuropathy peripheral
2%
Bone pain
2%
Rhinitis allergic
2%
Productive cough
2%
Pulmonary embolism
2%
Pain of skin
2%
Blister
2%
Palmar-plantar erythrodysesthesia syndrome
2%
Ephelides
2%
Photosensitivity reaction
2%
Neutropenia
2%
Abdominal pain lower
2%
Infusion related reaction
2%
Hyperglycemia
2%
Pulmonary congestion
2%
Scab
2%
Eyelash hypopigmentation
2%
Sepsis
2%
Pleural effusion
2%
Ocular hyperemia
2%
Chest pain
2%
Dysuria
2%
Spinal cord compression
2%
Oral pain
2%
Oral herpes
2%
Gamma-glutamyltransferase increased
1%
Hemorrhage intracranial
1%
Sinus pain
1%
Embolism
1%
Cardiac failure
1%
Biliary colic
1%
Biliary tract infection
1%
Lymphadenopathy
1%
Eructation
1%
Atrial fibrillation
1%
Multiple organ system dysfunction syndrome
1%
Pulmonary edema
1%
Ear discomfort
1%
Arthritis infective
1%
Lung infection
1%
Ear pain
1%
Peripheral swelling
1%
Dysphagia
1%
Skin infection
1%
Fungal skin infection
1%
Tooth infection
1%
Arthropod bite
1%
Wound
1%
Malignant melanoma
1%
Rash papular
1%
Aphasia
1%
Pleuritic pain
1%
Dermatitis bullous
1%
Papule
1%
Anal abscess
1%
Left ventricular dysfunction
1%
Hepatic failure
1%
Pelvic fracture
1%
Infusion site hematoma
1%
Memory impairment
1%
Nephrolithiasis
1%
Skin fissures
1%
Skin irritation
1%
Jaundice cholestatic
1%
Device related infection
1%
General physical condition decreased
1%
Platelet count decreased
1%
Hypertensive crisis
1%
Infarction
1%
Tinnitus
1%
Blood cholesterol increased
1%
Cholangitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 Dose Expansion: 68 mcg Tebentafusp
Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp
Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp
Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp
Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose expansionExperimental Treatment1 Intervention
Dose expansion cohort with the recommended phase 2 dose of the intra-patient dose escalation regimen.
Group II: Dose escalationExperimental Treatment1 Intervention
Dose escalation cohorts of the intra-patient escalation regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMCgp100
2016
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Immunocore LtdLead Sponsor
13 Previous Clinical Trials
3,623 Total Patients Enrolled

Frequently Asked Questions

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

How many facilities are currently managing this trial?

"This medical experiment is taking place in two dozen centres, including those located within Miami, New york and Oklahoma City. It would be prudent to select the nearest site if one intends on joining this clinical trial as it minimizes travel requirements."

Answered by AI

Are there any opportunities for individuals to participate in this experiment?

"This research is no longer recruiting participants. The trial was listed on February 1st 2016 and the last update occurred on March 10th 2022. As an alternative, there are 756 studies for melanoma that are currently enrolling patients as well as 3 trials specifically involving IMCgp100 which require volunteers."

Answered by AI

Is this a unique clinical trial?

"At present, three active trials for IMCgp100 are running in 49 cities across 15 nations. The first trial was launched by Immunocore Ltd back in 2015 and enrolled 312 patients who completed both the Phase 1 and 2 drug approval stages. Since then, two follow-up experiments have been concluded."

Answered by AI

What is the objective of this trial?

"Immunocore Ltd, the trial sponsor, has identified Objective Response Rate measured over up to 49 months as its primary outcome. Additionally, researchers will be monitoring Duration of Response in Phase 1 and ICR for Phase 2, Pharmacokinetic Parameter Tmax, and pharmacokinetic Parameter t1/2 during dose escalation cohorts."

Answered by AI

What further explorations have been conducted regarding IMCgp100?

"The inaugural research of IMCgp100 was conducted in 2015 at Istituto Tumori Napoli Fondazione G. Pascale and has since seen the completion of 2 trials studies. At present, 3 clinical investigations are underway, with a major focus being placed on Miami, Florida."

Answered by AI

How many participants are eligible for this research initiative?

"At this time, recruitment for the trial has closed. Initially posted on February 1st 2016 and last edited March 10th 2022, there are presently other studies available with 756 trials actively searching for melanoma patients and 3 recruiting IMCgp100 recipients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma
2016. "A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02570308.
~16 spots leftby Apr 2025
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