E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or Refractory Hodgkin’s Disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 5.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020266 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To characterize the best objective response rate of re-treatment with MDX-060 in patients with relapsed or refractory Hodgkin's Disease who, in protocol MDX060-03, had stable disease or better (partial or complete response) at Day 106 and subsequently experienced disease progression during the follow-up period. 2. To characterize the best objective response rate of MDX-060 plus gemcitabine in patients with relapsed or refractory Hodgkin's Disease who in protocol MDX060-03 experienced disease progression up to Day 106. |
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E.2.2 | Secondary objectives of the trial |
1. To characterize progression-free survival (PFS) in patients who received MDX-060 alone or in combination with gemcitabine. 2. To characterize time to progression (TTP) in patients who received MDX-060 alone or in combination with gemcitabine. 3. To determine response duration (RD). 4. To determine the immunogenicity of repeat cycles of MDX-060 in patients who received MDX-060 alone or in combination with gemcitabine. 5. To characterize health-related quality of life (QoL) in patients who received MDX-060 alone or in combination with gemcitabine. 6. To characterize the safety of MDX-060 alone or in combination with gemcitabine.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Experienced disease relapse or progression in Protocol MDX060-03; 2. Life expectancy ≥12 weeks; 3. Laboratory values must meet the following criteria: • WBC ≥ 1500/µL • Neutrophils ≥ 1000/µL • Platelets ≥ 75,000/µL • Hemoglobin ≥ 8 g/dL • Creatinine ≤ 2 ULN • AST ≤ 2 ULN • Serum total bilirubin ≤ 2 mg/dL (unless diagnosed with Gilbert’s syndrome) Laboratory abnormalities outside of the permissible range, but attributed to lymphoma, with clear involvement of the related organ, will be permitted; 4. Patient must have read and understood and provided written informed consent after the nature of the study has been fully explained; 5. Women of childbearing potential must have a negative serum β-HCG pregnancy test conducted during the pretreatment period (within 7 days of IMP administration) and a negative urine β-HCG pregnancy test conducted immediately prior to the first and fourth administrations of IMP at each cycle; 6. Men who may father a child must agree to the use of male contraception for the duration of their participation in the study; and 7. Patients on corticosteroids must be tapered offf the medication 2 weeks prior to MDX-060 administration and remain off corticosteroids until Day 106. |
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E.4 | Principal exclusion criteria |
1. Adverse event attributed to MDX-060 necessitating discontinuation of MDX-060; 2. Active significant infection; 3. Apparent active or latent infection, as indicated by any of the following: purified protein derivative (PPD) recently converted to positive; chest X-ray with evidence of infectious infiltrate; recent changes in fever/chill patterns (patients with a positive PPD who have a history of BCG vaccination, chest X-ray without evidence of tuberculosis, and no signs or symptoms of tuberculosis, will be permitted re-treatment). Patients with a positive PPD who have received prophylaxis will be permitted re-treatment; 4. Pregnant or nursing; 5. Any underlying condition which in the Investigator’s opinion will make the administration of IMP hazardous or obscure the interpretation of adverse events;or 6. Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Best Objective Response Rate (BORR) is the primary efficacy endpoint. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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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The study will terminate 2 years after the close of Protocol MDX060-03. |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |