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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019290-15 | EudraCT Number |
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IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The drug is designed to target melanoma cells and stimulate immune cells to kill them. This trial is designed to establish the level of drug that can be given to a patient that is tolerable. It also designed to establish the best dosing schedule for the drug and to look for signals that the drug is working as intended.
IMCgp100 is a bispecific biologic incorporating an engineered T cell receptor (TCR) specific for a peptide antigen derived from the protein gp100 presented in the context of HLA A2 on the surface of melanoma cells. The TCR is fused to an anti-CD3 antibody single-chain variable fragment (scFv) that recruits and activates non-melanoma specific T cells (killer T cells) in physical contact with the cancer T cell. This is a Phase I study designed to assess the safety profile and establish a tolerable dose of IMCgp100 in HLA A2 positive malignant melanoma patients. The study has two treatment arms with different treatment schedules, weekly or daily dosing. Each treatment arm in the study has two parts. In the first part, dose escalation, the safety and tolerability of the drug are examined and the optimal dose of drug is established. In the second part of the trial, participants will receive an extended course of treatment with a view to assessing the effect of the drug on disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMCgp100 weekly dosing regimen | Experimental | Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each. |
|
| IMCgp100 daily dosing regimen | Experimental | Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMCgp100 | Drug | For each arm, the study will be divided into two parts: In part 1, dose escalation, the MTD or RP2D for each dosing regimen will be established. In part 2, dose expansion, a cohort of participants will be treated at the RP2D or MTD. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of IMCgp100 Administered Weekly (Dose Escalation Part) | The maximum tolerated dose (MTD) for IMCgp100 administered by weekly dosing was determined based on the frequency of dose-limiting toxicity (DLT) occurring during Days 1 to 8. Participants presented at MTD in the dose escalation phase. Abbreviations: ng/kg=nanograms/kilogram | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 |
| MTD of IMCgp100 Administered Daily (Dose Escalation Part) | The MTD for IMCgp100 administered by daily dosing was determined based on the frequency of DLT occurring during Days 1 to 8. The 50 mcg dose was the RP2D for daily dosing, as the MTD was not achieved. Abbreviations: mcg=micrograms | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) with an onset date after the date of first dose and within 30 days after the last administration of study medication in either treatment arm. AEs with missing date of onset were considered treatment emergent. | Day 1 (first dose), 30 days after the last dose |
| Number of Participants Experiencing Clinically Significant Laboratory Parameters (Hematology) | Laboratory parameters included clinical chemistry, hematology, and urinalysis. For hematology, this included red cell count, hemoglobin, hematocrit, mean cell volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, leukocyte differential count (percentage or absolute), prothrombin time, and activated partial tissue thromboplastin time. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose. | 28 months |
| Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Hematology) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Overall Response Per Response Evaluation Criteria In Solid Tumors (RECIST) (Weekly Dosing-Dose Expansion Part) | The best overall response was assigned as complete response (CR), partial response (PR), minor response, stable disease, progressive disease (PD) or not evaluable (NE) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. | 28 months |
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Inclusion Criteria:
Pathologically documented Stage IV malignant melanoma or unresectable Stage III melanoma for which no standard effective therapy exists or for which an appropriate window exists between alternative therapeutic options. Participants for whom early treatment with vemurafenib is indicated, e.g. rapidly progressing or symptomatic disease, are excluded from this trial.
Previous surgery (other than resection of skin metastases), radiotherapy, chemotherapy, immunotherapy or experimental therapy completed > 4 weeks before and all adverse events resolved to ≤ grade 1. In cases where localized radiotherapy has been applied, treatment with IMCgp100 can be commenced after a two week period.
Human leukocyte antigen (HLA) A2 positive.
≥ 18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Participants participating in the dose escalation part of Arm 2 only require assessable disease.
Life expectancy > 3 months.
Blood tests within the following parameters:
Female participants of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 6 months following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female participants must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile.
Male participants must be surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last study drug infusion.
Participants with a history of adrenal insufficiency, maintained on stable replacement dose corticosteroid (< 10 mg/d prednisone or the equivalent) are eligible for treatment with IMCgp100, unless there is a past history of adrenal crisis. Eligible participants with a history of adrenal insufficiency receiving replacement dose corticosteroid must receive prophylactic stress dose corticosteroid prior to dosing during the first four doses of IMCgp100 treatment, regardless of weekly or daily dosing regimen.
Able to give informed consent.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study:
Symptomatic brain metastases that are unstable, require steroids, or that have required radiation within the last 28 days.
Other active malignancy in the past 5 years except carcinoma in situ, completely excised nonmelanomatous skin cancer or any other malignancy that in the opinion of the investigator is considered to be cured.
Comorbid medical condition that would increase the risk of toxicity in the opinion of the investigator or sponsor. Symptomatic on-going infection must be resolved before the patient can be treated in the study.
Uveitis.
Had myocardial infarction within 1 year before enrolment, symptomatic congestive heart failure (New York Heart Association > Class II), unstable angina or unstable cardiac arrhythmia requiring medication.
Has an ejection fraction < 50%.
Clinically significant electrocardiogram (ECG) changes that obscure the ability to assess the RR, PR and QT intervals. Participants with corrected QT interval (QTc) calculated by Bazetts or locally preferred formula which is greater than 500 ms.
Has hepatic function as follows:
Bleeding diathesis
Immunosuppressive condition or treatment including previous transplantation, splenectomy or known human immunodeficiency virus (HIV) infection.
Has a history of adult seizures.
Participants with evidence of a raised intracranial pressure in Arm 2 of the study who will have a cerebrospinal fluid sample taken.
Participants receiving chronic corticosteroid treatment (longer than 8 weeks duration) for management of pre-existing adverse events at any dose, or participants with a history of chronic corticosteroid treatment longer than 8 weeks duration for adverse events within 6 months.
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| Name | Affiliation | Role |
|---|---|---|
| Namir Hassan, PhD | Immunocore Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic | Los Angeles | California | 90025 | United States | ||
| Yale Cancer Center |
All-patients population and safety population both comprised 84 participants who enrolled in the study and who also received at least one IMCgp100 dose; the all-patients and safety population for Arm 1 was 66 participants and for Arm 2 was 18 participants. Efficacy population was 54 participants in Arm 1 and 15 participants in Arm 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMCgp100 Weekly Dosing Regimen | Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each. |
| FG001 | IMCgp100 Daily Dosing Regimen | Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Laboratory parameters included clinical chemistry, hematology, and urinalysis. For hematology, this included red cell count, hemoglobin, hematocrit, mean cell volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, leukocyte differential count (percentage or absolute), prothrombin time, and activated partial tissue thromboplastin time. Laboratory parameter abnormalities were graded by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death. |
| 28 months |
| Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry) | Laboratory parameters included clinical chemistry, hematology, and urinalysis. Clinical chemistry parameters included calcium, phosphorus, magnesium, albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, lactate dehydrogenase, sodium, potassium, bicarbonate, creatinine, chloride, glucose, urea, uric acid, and C-reactive protein. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose. | 28 months |
| Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Clinical Chemistry) | Laboratory parameters included clinical chemistry, hematology, and urinalysis. Clinical chemistry parameters included calcium, phosphorus, magnesium, albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, lactate dehydrogenase, sodium, potassium, bicarbonate, creatinine, chloride, glucose, urea, uric acid, and C-reactive protein. Laboratory parameter abnormalities were graded by the investigator using CTCAE v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death. | 28 months |
| Number of Participants Experiencing Clinically Significant Electrocardiograms (ECGs) | Twelve lead ECGs were obtained after the participant has rested in a supine position for at least 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator or designated physician occurring at any time on treatment from normal pre-dose. | 28 months |
| Number of Participants Experiencing Clinically Significant Vital Signs | Vital signs included temperature, blood pressure, respiration rate, and heart rate. Measurements were made after the participant had been resting supine for a minimum of 5 minutes. Blood pressure and heart rate were measured using a recording device with an appropriate cuff size. Temperature and respiration rate were measured as per clinical practice. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose. | 28 months |
| Number of Participants Experiencing Clinically Significant Physical Examination Results (Weight Decrease) | Physical examination included weight, a record of skin pigmentation, and photographic record of any vitiligo if present. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose. | 28 months |
| Number of Participants Experiencing ≥Grade 3 Severity in Physical Examination Results (Skin Pigmentation) | Physical examination included weight, a record of skin pigmentation, and photographic record of any vitiligo if present. Abnormalities were graded by the investigator using CTCAE v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death. | 28 months |
| Number of Participants With Anti-IMCgp100 Antibody Formation (Dose Escalation and Dose Expansion Parts) | To provide a comprehensive anti-drug antibody (ADA) summary for the study, individual participant data were combined and assessed as distinct groups based on characteristics of their ADA response. Evaluable participants were those with post-drug administration samples. ADA prevalence (pre- existing antibody response) was measured as the number of baseline-positive participant out of all participants who provided baseline samples. Overall ADA incidence was calculated based on the combined number of treatment-boosted and treatment-induced ADA-positive participants. The treatment-induced incidence was determined as the number of ADA- positive participants of those that were ADA-negative at baseline; while treatment-boosted incidence was determined as the number of participants with an ADA titer increase equal to or greater than the minimum significant dilution (3-fold) of the assay. | 28 months |
| Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation) | The maximum plasma concentration (Cmax) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. Abbreviations: ng/kg = nanograms/kilogram | Day 1, Cycle 1 |
| Estimated Cmax of IMCgp100 of 900 ng/kg By-weight Dose (Dose Escalation and Dose Expansion Parts) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. | Day 1, Cycle 1 |
| Estimated Cmax of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. Abbreviations: mcg = micrograms | Day 1, Cycle 1 |
| Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. | Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 |
| Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. On Day 1, IMCgp100 20 mcg was given, IMCgp100 30 mcg was administered on Day 8, and IMCgp100 50 mcg was dosed on Days 15 and after. | Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 |
| Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. This dosing regimen was implemented following the Urgent Safety Measure to adapt the dosing in the Phase 1 study that dropped Dose 1 to 40 mcg from the identified 50 mcg RP2D. | Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 |
| Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The RP2D identified in this study following review of all safety and pharmacokinetic data in the dose escalation of the Phase 1 study was the 50 mcg flat dose. | Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 |
| Estimated Cmax of IMCgp100 of a Single Infusion Flat Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. | Cycle 1: Day 1 |
| Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation) | The area under the concentration-time curve (AUC), measured in hours by picograms per milliliter ( h*pg/ml) is a method of measurement of the total exposure of a drug in blood. | Day 1, Cycle 1 |
| AUC of IMCgp100 of 900 ng/kg By-weight Dose (Dose Escalation and Dose Expansion Parts) | The AUC, measured in h*pg/ml, is a method of measurement of the total exposure of a drug in blood. | Day 1, Cycle 1 |
| AUC of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts) | The AUC (measured in h*pg/ml) is a method of measurement of the total exposure of a drug in blood. Participants in the 20 mcg and 40 mcg dose groups received intra-participant dose-escalation up to 50 mcg on Day 15. | Day 1, Cycle 1 |
| AUC of IMCgp100 of 50 mcg Flat Dose (Dose Escalation and Dose Expansion Parts) | The AUC (measured in h*pg/ml) is a method of measurement of the total exposure of a drug in blood. | Day 1, Cycle 1 |
| New Haven |
| Connecticut |
| 06520-8028 |
| United States |
| Memorial Slone Kettering Cancer Center | New York | New York | 10065 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Queen Elizabeth Hospital | Birmingham | United Kingdom |
| Addenbrooke's Hospital | Cambridge | United Kingdom |
| The Beatson Institute | Glasgow | United Kingdom |
| St James Hospital | Leeds | United Kingdom |
| NIHR Biomedical Research Centre | Oxford | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: The all-patients population and the safety population both comprised the 84 participants who enrolled in the study and who also received at least one IMCgp100 dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | IMCgp100 Weekly Dosing Regimen | Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each. |
| BG001 | IMCgp100 Daily Dosing Regimen | Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of IMCgp100 Administered Weekly (Dose Escalation Part) | The maximum tolerated dose (MTD) for IMCgp100 administered by weekly dosing was determined based on the frequency of dose-limiting toxicity (DLT) occurring during Days 1 to 8. Participants presented at MTD in the dose escalation phase. Abbreviations: ng/kg=nanograms/kilogram | Safety population: all participants who received at least 1 dose of IMCgp100, up to a maximum of 600 ng/kg. | Posted | Number | ng/kg | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 |
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| Primary | MTD of IMCgp100 Administered Daily (Dose Escalation Part) | The MTD for IMCgp100 administered by daily dosing was determined based on the frequency of DLT occurring during Days 1 to 8. The 50 mcg dose was the RP2D for daily dosing, as the MTD was not achieved. Abbreviations: mcg=micrograms | Safety population: all participants who received at least 1 dose of IMCgp100 | Posted | Number | mcg | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 |
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| Primary | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) with an onset date after the date of first dose and within 30 days after the last administration of study medication in either treatment arm. AEs with missing date of onset were considered treatment emergent. | Safety Population | Posted | Number | percentage of participants | Day 1 (first dose), 30 days after the last dose |
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| Primary | Number of Participants Experiencing Clinically Significant Laboratory Parameters (Hematology) | Laboratory parameters included clinical chemistry, hematology, and urinalysis. For hematology, this included red cell count, hemoglobin, hematocrit, mean cell volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, leukocyte differential count (percentage or absolute), prothrombin time, and activated partial tissue thromboplastin time. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose. | Safety Population | Posted | Number | number of participants | 28 months |
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| Primary | Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Hematology) | Laboratory parameters included clinical chemistry, hematology, and urinalysis. For hematology, this included red cell count, hemoglobin, hematocrit, mean cell volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, leukocyte differential count (percentage or absolute), prothrombin time, and activated partial tissue thromboplastin time. Laboratory parameter abnormalities were graded by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death. | Safety Population | Posted | Number | number of participants | 28 months |
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| Primary | Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry) | Laboratory parameters included clinical chemistry, hematology, and urinalysis. Clinical chemistry parameters included calcium, phosphorus, magnesium, albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, lactate dehydrogenase, sodium, potassium, bicarbonate, creatinine, chloride, glucose, urea, uric acid, and C-reactive protein. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose. | Safety Population | Posted | Number | number of participants | 28 months |
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| Primary | Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Clinical Chemistry) | Laboratory parameters included clinical chemistry, hematology, and urinalysis. Clinical chemistry parameters included calcium, phosphorus, magnesium, albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, lactate dehydrogenase, sodium, potassium, bicarbonate, creatinine, chloride, glucose, urea, uric acid, and C-reactive protein. Laboratory parameter abnormalities were graded by the investigator using CTCAE v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death. | Safety Population | Posted | Number | number of participants | 28 months |
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| Primary | Number of Participants Experiencing Clinically Significant Electrocardiograms (ECGs) | Twelve lead ECGs were obtained after the participant has rested in a supine position for at least 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator or designated physician occurring at any time on treatment from normal pre-dose. | Safety Population | Posted | Number | number of participants | 28 months |
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| Primary | Number of Participants Experiencing Clinically Significant Vital Signs | Vital signs included temperature, blood pressure, respiration rate, and heart rate. Measurements were made after the participant had been resting supine for a minimum of 5 minutes. Blood pressure and heart rate were measured using a recording device with an appropriate cuff size. Temperature and respiration rate were measured as per clinical practice. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose. | Safety Population | Posted | Number | number of participants | 28 months |
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| Primary | Number of Participants Experiencing Clinically Significant Physical Examination Results (Weight Decrease) | Physical examination included weight, a record of skin pigmentation, and photographic record of any vitiligo if present. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose. | Safety Population | Posted | Number | number of participants | 28 months |
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| Primary | Number of Participants Experiencing ≥Grade 3 Severity in Physical Examination Results (Skin Pigmentation) | Physical examination included weight, a record of skin pigmentation, and photographic record of any vitiligo if present. Abnormalities were graded by the investigator using CTCAE v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death. | Safety Population | Posted | Number | number of participants | 28 months |
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| Secondary | Number of Participants With Best Overall Response Per Response Evaluation Criteria In Solid Tumors (RECIST) (Weekly Dosing-Dose Expansion Part) | The best overall response was assigned as complete response (CR), partial response (PR), minor response, stable disease, progressive disease (PD) or not evaluable (NE) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. | Efficacy population: only evaluable participants (those having both a baseline and post treatment sample). | Posted | Number | participants | 28 months |
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| Secondary | Number of Participants With Anti-IMCgp100 Antibody Formation (Dose Escalation and Dose Expansion Parts) | To provide a comprehensive anti-drug antibody (ADA) summary for the study, individual participant data were combined and assessed as distinct groups based on characteristics of their ADA response. Evaluable participants were those with post-drug administration samples. ADA prevalence (pre- existing antibody response) was measured as the number of baseline-positive participant out of all participants who provided baseline samples. Overall ADA incidence was calculated based on the combined number of treatment-boosted and treatment-induced ADA-positive participants. The treatment-induced incidence was determined as the number of ADA- positive participants of those that were ADA-negative at baseline; while treatment-boosted incidence was determined as the number of participants with an ADA titer increase equal to or greater than the minimum significant dilution (3-fold) of the assay. | Efficacy population | Posted | Number | participants | 28 months |
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| Secondary | Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation) | The maximum plasma concentration (Cmax) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. Abbreviations: ng/kg = nanograms/kilogram | Pharmacokinetics (PK) Population: all participants who receive at least 1 dose of IMCgp100 and have at least 1 measurable PK concentration with the relevant date, time and dosing data for this sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms/milliliter | Day 1, Cycle 1 |
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| Secondary | Estimated Cmax of IMCgp100 of 900 ng/kg By-weight Dose (Dose Escalation and Dose Expansion Parts) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms/milliliter | Day 1, Cycle 1 |
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| Secondary | Estimated Cmax of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. Abbreviations: mcg = micrograms | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms/milliliter | Day 1, Cycle 1 |
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| Secondary | Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. | PK Population | Posted | Mean | Standard Deviation | picograms/milliliter | Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 |
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| Secondary | Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. On Day 1, IMCgp100 20 mcg was given, IMCgp100 30 mcg was administered on Day 8, and IMCgp100 50 mcg was dosed on Days 15 and after. | PK Population | Posted | Mean | Standard Deviation | mcg | Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 |
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| Secondary | Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. This dosing regimen was implemented following the Urgent Safety Measure to adapt the dosing in the Phase 1 study that dropped Dose 1 to 40 mcg from the identified 50 mcg RP2D. | PK Population | Posted | Mean | Standard Deviation | mcg | Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 |
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| Secondary | Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The RP2D identified in this study following review of all safety and pharmacokinetic data in the dose escalation of the Phase 1 study was the 50 mcg flat dose. | PK Population | Posted | Mean | Standard Deviation | mcg | Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 |
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| Secondary | Estimated Cmax of IMCgp100 of a Single Infusion Flat Dose (Dose Escalation) | The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms/milliliter | Cycle 1: Day 1 |
|
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| Secondary | Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation) | The area under the concentration-time curve (AUC), measured in hours by picograms per milliliter ( h*pg/ml) is a method of measurement of the total exposure of a drug in blood. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * picograms/milliliter | Day 1, Cycle 1 |
|
| ||||||||||||||||||||||||||
| Secondary | AUC of IMCgp100 of 900 ng/kg By-weight Dose (Dose Escalation and Dose Expansion Parts) | The AUC, measured in h*pg/ml, is a method of measurement of the total exposure of a drug in blood. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * picograms/milliliter | Day 1, Cycle 1 |
|
| ||||||||||||||||||||||||||
| Secondary | AUC of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts) | The AUC (measured in h*pg/ml) is a method of measurement of the total exposure of a drug in blood. Participants in the 20 mcg and 40 mcg dose groups received intra-participant dose-escalation up to 50 mcg on Day 15. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * picograms/milliliter | Day 1, Cycle 1 |
|
| ||||||||||||||||||||||||||
| Secondary | AUC of IMCgp100 of 50 mcg Flat Dose (Dose Escalation and Dose Expansion Parts) | The AUC (measured in h*pg/ml) is a method of measurement of the total exposure of a drug in blood. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * picograms/milliliter | Day 1, Cycle 1 |
|
|
Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMCgp100 Weekly Dosing Regimen | Weekly intravenous (IV) infusions of IMCgp100 at the weekly maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) over treatment cycles of eight weeks each. | 8 | 66 | 24 | 66 | 66 | 66 |
| EG001 | IMCgp100 Daily Dosing Regimen | Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six week treatment cycle at the MTD/daily RP2D. | 8 | 18 | 5 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| INTRA-ABDOMINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ADVERSE DRUG REACTION | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| CYTOKINE RELEASE SYNDROME | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BILIARY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| GASTRIC INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| LABORATORY TEST ABNORMAL | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| LIVER FUNCTION TEST INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ERYTHEMA OF EYELID | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| EYE IRRITATION | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| EYE PAIN | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| EYELID OEDEMA | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| OCULAR HYPERAEMIA | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PERIORBITAL OEDEMA | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| AXILLARY PAIN | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FACE OEDEMA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ANGULAR CHEILITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| CATHETER SITE INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| RASH PUSTULAR | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOPROTEINAEMIA | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SPEECH DISORDER | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HALLUCINATION | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RALES | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BLOOD BLISTER | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| COLD SWEAT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| GENERALISED ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HAIR COLOUR CHANGES | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| ONYCHOCLASIS | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| VITILIGO | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
Publication/presentation (manuscript, abstract or poster) to a journal/scientific meeting is sent to sponsor for review at least 1 month before submission who may delay submission by up to 90 days if it reasonably believes that publication of results may compromise its intellectual property rights or else insist that such data are removed. No single center/groups of centers may publish individually. Publication will not include confidential information without the permission of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Holland, Executive Director Head of Biostatistics | Immunocore, LLC | 1-267-589-9204 | chris.holland2@immunocore.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Male |
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| Black |
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| Asian |
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| Other |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 20 mcg |
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| 40 mcg |
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| 50 mcg |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 1 |
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| Day 8 |
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| Day 15 |
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| Day 22 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 50 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 10 mcg |
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| 20 mcg |
|
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| 30 mcg |
|
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| 40 mcg |
|
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| 50 mcg |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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