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Alkylating agents
IMCgp100 for Uveal Melanoma
Phase 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
No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization
Histologically or cytologically confirmed metastatic UM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 assessments will be performed between first dose of imcgp100 and end of treatment, assessed up to 5.5 years.
Awards & highlights
Study Summary
This trial is looking at whether a new drug, IMCgp100, is better than other standard treatments for people with a certain type of cancer.
Who is the study for?
Adults with advanced Uveal Melanoma (UM) who haven't had systemic or regional liver-directed therapy for metastatic UM can join. They must be HLA-A*0201 positive, have measurable disease, and a good performance status. Excluded are those on steroids/immunosuppressants, with certain medical histories like severe allergies to biologics or active infections requiring antibiotics.Check my eligibility
What is being tested?
The trial is testing the effectiveness of IMCgp100 compared to other treatments (dacarbazine, ipilimumab, pembrolizumab) in improving survival rates for patients with advanced UM. Participants will be assigned to receive either IMCgp100 or one of the investigator's choice drugs.See study design
What are the potential side effects?
IMCgp100 and other study drugs may cause immune-related reactions, fatigue, skin issues, digestive problems and potential risks related to organ inflammation. Specific side effects depend on the drug received but generally include typical chemotherapy and immunotherapy-related adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had any liver-targeted treatments like chemo, radiation, or embolization.
Select...
My cancer, known as UM, has spread and this was confirmed through testing.
Select...
I haven't received any systemic therapy for my advanced or metastatic cancer.
Select...
My genetic test shows I am HLA A*0201 positive.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 assessments will be performed between first dose of imcgp100 and end of treatment, assessed up to 5.5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 assessments will be performed between first dose of imcgp100 and end of treatment, assessed up to 5.5 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy: Overall Survival
Secondary outcome measures
Efficacy: Disease Control Rate (DCR)
Efficacy: Duration of Response (DOR)
Efficacy: Objective Response Rate (ORR)
+7 moreSide effects data
From 2022 Phase 1 & 2 trial • 146 Patients • NCT0257030881%
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%
Dermal cyst
2%
Upper-airway cough syndrome
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
Active Control
Group I: IMCgp100 (tebentafusp, Kimmtrak)Experimental Treatment1 Intervention
Biologic:IMCgp100 (Soluble gp 100-specific T cell receptor with anti - CD3 scFV: IMCgp100)
Group II: Investigator's ChoiceActive Control3 Interventions
1 of 3 Investigator's Choice options: Systemic Dacarbazine
1 of 3 Investigator's Choice options: Systemic Ipilimumab
1 of 3 Investigator's Choice options: Systemic Pembrolizumab
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
3,391 Total Patients Enrolled
Immunocore Trial DisclosureStudy DirectorImmunocore Ltd
Mohammed DarStudy DirectorImmunocore Ltd
1 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have brain metastases needing steroids in the last 3 weeks.I have not had major surgery within the last 2 weeks.I have a history of adrenal insufficiency.I do not have any cancer other than the one being treated in this study.I am currently on steroids or other medications that weaken my immune system.I have had or currently have lung inflammation treated with steroids.I am a woman who can have children and am sexually active with a man who is not sterilized.I cannot receive standard treatments like dacarbazine, ipilimumab, or pembrolizumab due to health reasons.I've had initial treatment for my cancer when it was localized, aiming for a cure.I haven't used any bone marrow growth factors in the last 2 weeks.I am a male and will use double barrier contraception during and for 6 months after the study.I am 18 years old or older.I have a history of lung scarring or fibrosis.I haven't had radiotherapy in the last 2 weeks, except for palliative care.You have been diagnosed with HIV.You have an active hepatitis B or hepatitis C virus infection according to the hospital's rules.You are in a hospital because you were ordered to be there by a court or other official authority.I have a history of colitis or inflammatory bowel disease.I haven't had any liver-targeted treatments like chemo, radiation, or embolization.I am currently on antibiotics for an infection.You have had severe allergic reactions to other similar medications in the past.My cancer, known as UM, has spread and this was confirmed through testing.I haven't received any systemic therapy for my advanced or metastatic cancer.Your lab test results are not within the normal range.You have a disease that can be measured or observed according to specific guidelines.I had surgery to remove a few cancer spread spots.I have a heart condition that affects my daily life.My genetic test shows I am HLA A*0201 positive.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: IMCgp100 (tebentafusp, Kimmtrak)
- Group 2: Investigator's Choice
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What pathological conditions does IMCgp100 have a track record of ameliorating?
"IMCgp100, which is a viable treatment for unresectable melanoma, can also be employed to manage microsatellite instability high and pheochromocytomas as well as reduce the risk of recurrence."
Answered by AI
Is the age restriction for this research study limited to individuals over 20 years old?
"This research study is recruiting volunteers aged 18 or older but younger than 99."
Answered by AI
How many participants are engaged in the current research project?
"This particular trial is no longer seeking patients, having last been updated on the 10th of March 2022. For those exploring other options, there are currently 756 melanoma and uveal trials actively recruiting as well as 1286 IMCgp100 studies in process."
Answered by AI
To whom is this research open for enrollment?
"This medical trial seeks 378 patients aged 18 to 99 with uveal melanoma. All participants must have the capacity for understanding written informed consent, and no prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy (prior surgical resection of oligometastatic disease is acceptable). In addition to this criteria, individuals may not be re-treated with an Investigator's Choice therapy that was administered as adjuvant/neoadjuvant treatment; furthermore those who have received nivolumab previously cannot receive pembrolizumab as a choice by their doctor. Aspiring enrollees"
Answered by AI
Does this research currently accept new participants?
"This experiment is no longer accepting participants. It was first posted in October 2017 and last updated on March 2022. If you are searching for additional trials, there are 756 studies recruiting patients with melanoma and 1286 clinical tests looking to enrol individuals receiving IMCgp100 treatment."
Answered by AI
In what areas can this clinical experiment be accessed?
"Presently, 26 medical sites are enrolling patients for this trial. Some of the locales include Edmonton, San Francisco and New york. To reduce travel time to your appointment it is wise to select a clinic close by you when signing up."
Answered by AI
What other analyses have been conducted related to IMCgp100?
"Presently, there are 1,286 studies pertaining to IMCgp100; 166 of these research programs exist in Phase 3. Though most trials connected with this therapy take place in Houston, Texas, it is possible to find clinical sites running investigation all across the USA."
Answered by AI
What adverse effects have been observed in individuals using IMCgp100?
"The safety rating for IMCgp100 is 2, as there are limited clinical data to indicate its efficacy but evidence suggesting it may be safe."
Answered by AI
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