Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma | Recruiting
Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma
Health Conditions
  • Malignant Melanoma
Recruiting
Recruitment Status
NCT01211262
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • Definition of the maximum tolerated dose (MTD) and evaluation of the safety and tolerability of multiple injections of IMCgp100 for each of two treatment regimens (weekly dosing and daily dosing); 28 months
Secondary Outcome Measures
  • Characterisation of the pharmacokinetics and changes in tumour burden following IMCgp100 administration; 28 months
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
80
Participant Inclusion Criteria
  • Inclusion Criteria:
  • 1. 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. Patients for whom early
  • treatment with vemurafenib is indicated e.g. rapidly progressing or symptomatic
  • disease, are excluded from this trial.
  • 2. 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 localised radiotherapy has been
  • applied, treatment with IMCgp100 can be commenced after a two week period.
  • 3. HLA A2 positive.
  • 4. ≥ 18 years old.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • 6. For patients in the Dose-Expansion part only, measurable disease according to RECIST
  • criteria. For patients in the Dose-escalation part of the study, only 'assessable
  • disease' is required.
  • 7. Life expectancy >3 months.
  • 8. Blood tests within the following parameters:
  • 1. Platelet count ≥100 x 109/L
  • 2. Haemoglobin ≥10g/dL
  • 3. Calculated creatinine clearance ≥60 mL/min using the modified Cockcroft-Gault
  • equation
  • 4. Neutrophil counts ≥1x109/L
  • 5. Lymphocyte count ≥0.5x109/L
  • 9. Female patients 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 patients must be
  • postmenopausal (no menstrual period for a minimum of 12 months) or surgically
  • sterile.
  • 10. Male patients must be surgically sterile or willing to use a double barrier
  • contraception method upon enrolment, during the course of the study, and for 6 months
  • following the last study drug infusion.
  • 11. Able to give informed consent.
  • Exclusion Criteria:
  • 1. Symptomatic brain metastases that are unstable, require steroids, or that have
  • required radiation within the last 28 days
  • 2. Other active malignancy in the past 5 years except carcinoma in situ, completely
  • excised non-melanomatous skin cancer or any other malignancy that in the opinion of
  • the investigator is considered to be cured.
  • 3. Comorbid medical condition that would increase the risk of toxicity in the opinion of
  • the investigator or sponsor. Any symptomatic ongoing infection must be resolved
  • before the patient can be treated in the study.
  • 4. Uveitis
  • 5. 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.
  • 6. Has an ejection fraction <50%.
  • 7. Clinically significant electrocardiogram (ECG) changes that obscure the ability to
  • assess the RR, PR and QT intervals. Patients with QTc calculated by Bazetts or
  • locally preferred formula which is greater than 500ms.
  • 8. Has hepatic function as follows:
  • 1. Aspartate aminotransferase >2.5 x upper limit of normal (ULN)
  • 2. Alanine aminotransferase >2.5 x ULN
  • 3. Bilirubin >2.0 x ULN
  • 4. Prothrombin time or partial thromboplastin time>1.5 x ULN
  • 9. Bleeding diathesis.
  • 10. Immunosuppressive condition or treatment including previous transplantation,
  • splenectomy or known HIV infection.
  • 11. Has a history of adult seizures.
Participant Exclusion Criteria
  • Inclusion Criteria:
  • 1. 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. Patients for whom early
  • treatment with vemurafenib is indicated e.g. rapidly progressing or symptomatic
  • disease, are excluded from this trial.
  • 2. 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 localised radiotherapy has been
  • applied, treatment with IMCgp100 can be commenced after a two week period.
  • 3. HLA A2 positive.
  • 4. ≥ 18 years old.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • 6. For patients in the Dose-Expansion part only, measurable disease according to RECIST
  • criteria. For patients in the Dose-escalation part of the study, only 'assessable
  • disease' is required.
  • 7. Life expectancy >3 months.
  • 8. Blood tests within the following parameters:
  • 1. Platelet count ≥100 x 109/L
  • 2. Haemoglobin ≥10g/dL
  • 3. Calculated creatinine clearance ≥60 mL/min using the modified Cockcroft-Gault
  • equation
  • 4. Neutrophil counts ≥1x109/L
  • 5. Lymphocyte count ≥0.5x109/L
  • 9. Female patients 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 patients must be
  • postmenopausal (no menstrual period for a minimum of 12 months) or surgically
  • sterile.
  • 10. Male patients must be surgically sterile or willing to use a double barrier
  • contraception method upon enrolment, during the course of the study, and for 6 months
  • following the last study drug infusion.
  • 11. Able to give informed consent.
  • Exclusion Criteria:
  • 1. Symptomatic brain metastases that are unstable, require steroids, or that have
  • required radiation within the last 28 days
  • 2. Other active malignancy in the past 5 years except carcinoma in situ, completely
  • excised non-melanomatous skin cancer or any other malignancy that in the opinion of
  • the investigator is considered to be cured.
  • 3. Comorbid medical condition that would increase the risk of toxicity in the opinion of
  • the investigator or sponsor. Any symptomatic ongoing infection must be resolved
  • before the patient can be treated in the study.
  • 4. Uveitis
  • 5. 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.
  • 6. Has an ejection fraction <50%.
  • 7. Clinically significant electrocardiogram (ECG) changes that obscure the ability to
  • assess the RR, PR and QT intervals. Patients with QTc calculated by Bazetts or
  • locally preferred formula which is greater than 500ms.
  • 8. Has hepatic function as follows:
  • 1. Aspartate aminotransferase >2.5 x upper limit of normal (ULN)
  • 2. Alanine aminotransferase >2.5 x ULN
  • 3. Bilirubin >2.0 x ULN
  • 4. Prothrombin time or partial thromboplastin time>1.5 x ULN
  • 9. Bleeding diathesis.
  • 10. Immunosuppressive condition or treatment including previous transplantation,
  • splenectomy or known HIV infection.
  • 11. Has a history of adult seizures.
Interventions
Drug; IMCgp100; For each arm the study will be divided into two parts: In part 1, dose escalation, the MTD for each dosing regimen will be established. In part 2, dose expansion, a cohort of patients will be treated at MTD.; [IMCgp100 weekly dosing regimen, IMCgp100 daily dosing regimen]
Design Details
Sorry, this information is not available
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
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Scientific Title
A Phase 1, Open Label, Dose Finding Study to Assess the Safety and Tolerability of IMCgp100, a Monoclonal T Cell Receptor Anti-CD3 scFv Fusion Protein in Patients With Advanced Malignant Melanoma
Secondary Trial Identifying Number
2010-019290-15
Website
Sorry, this information is not available
Study Funded By
Immunocore Ltd
Funder Type
Sorry, this information is not available
Study Sponsored By
Immunocore Ltd
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

28 Sep 2010

Last Updated

08 Jan 2015

Date Record Refreshed on UKCTG

24 Jul 2015