E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HLA-A*0201-Positive Patients with Previously Treated, Unresectable Stage III or IV Melanoma |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study in patients with unresectable Stage III or IV melanoma who have been previously treated with other agents, is to compare overall survival of patients administered MDX-010 in combination with gp100 melanoma peptide vaccine versus those administered gp100 melanoma peptide vaccine alone. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are: 1. Comparison of overall survival of patients administered MDX-010 in combination with gp100 melanoma peptide vaccine vs. those administered MDX-010 monotherapy, and of patients administered vaccine monotherapy vs. those administered MDX-010 monotherapy; 2. Determination of the safety; 3. Evaluation of best overall response rate (BORR); 4. Determination of major durable response rate; 5. Determination of duration of response; 6. Determination of progression-free survival; 7. Determination of time-to-progression; and 8. Evaluation of health-related Quality of Life. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histologic diagnosis of malignant melanoma; Measureable unresectable Stage III or IV melanoma; at least 18 years of age; positive for HLA-A*0201; have demonstrated 1 of the following in response to at least 1 cycle of 1 or more regimens containing 1 or more of the following: IL-2, dacarbazine, temozolamide, fotemustine and/or carboplatin: 1) relapse following an objective response, 2) failed to demonstrate an objective response, or 3) inability to tolerate treatment due to unacceptable toxicity; at least 28 days since treatment with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy, and 14 days for gamma knife treatment and recovered from any clinically significant toxicity experienced during treatment; Women must meet 1 of the following criteria: post menopausal for at least 1 year; surgically incapable of bearing children, or utilizing a reliable form of contraception. Women of childbearing potential must have negative pregnancy tests; Men who may father a child must agree to the use of male contraception; Life expectancy greater than 4 months; ECOG of 0 or 1; meet required lab values; and negative HIV, HepB and HepC tests. |
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E.4 | Principal exclusion criteria |
Any other prior malignancy from which the patient has been disease free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or adequately treated carcinoma in situ of the cervix, breast or bladder; Primary ocular melanoma; Active, untreated CNS metastasis; Prior treatment with an anit-CTLA4 antibody; Prior treatment with any cancer therapeutic vaccine, including gp100 peptides; Active autoimmune disease or a history of autoimmune disease except for patients with vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism; Pregnant or nursing; Concomitant therapy with IL-2, interferon or other non-study anti-melanoma immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, or other investigational therapies, or chronic use of systemic corticosteroids; or the inability to provide adequate informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the comparison of overall survival of patients administered MDX-010 in combination with gp100 melanoma peptide vaccine versus those administered gp100 melanoma peptide vaccine alone. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
MDX-010 + Placebo Combination Therapy versus Placebo + MDX-1379 Combination Therapy |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |