E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or Refractory Hodgkin’s Disease |
|
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 |
|
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 |
To measure best objective response rate up to Day 106 in patients with relapsed or refractory Hodgkin's disease administered MDX-060. |
|
E.2.2 | Secondary objectives of the trial |
1. To characterize progression-free survival 2. To characterize time to progression 3. To determine response duration 4. To determine immunogenicity of MDX-060 5. To explore the correlation of PET scan results with objective response observed with conventional imaging in this patient population 6. To characterize the health-related QoL in patients who recieved MDX-060 7. To characterize the safety of MDX-060 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Diagnosis of HD (excluding HIV-associated HD); 2. Patients must have failed or relapsed second line (i.e., salvage) chemotherapy or relapsed or failed autologous stem cell transplant. Patients who are not candidates for stem cell transplant, exhibit chemo-resistant disease, or refuse further chemotherapy may also be included; 3. Patients must have measurable disease; 4. At least 4 weeks since the last chemotherapy or radiation prior to the first dosing of MDX-060 and have recovered from any toxicity associated with such treatment or returned to baseline; 5. Age ≥ 18 years; 6. Life expectancy ≥12 weeks; 7. ECOG Performance Status of 0 – 2 (Appendix 2); 8. Screening laboratory values must meet the following criteria: • WBC ≥ 1500/µL • Neutrophils ≥ 1000/µL • Platelets ≥ 75,000/µL • Hemoglobin ≥ 8.0 g/dL • Creatinine ≤ 2 ULN • AST ≤ 2 ULN • Serum total bilirubin ≤ 2 mg/dL (unless diagnosed with Gilbert’s syndrome) • HIV negative • Hepatitis B surface antigen negative for active or chronic infection • Hepatitis C antibody negative for active or chronic infection Laboratory abnormalities outside of the permissible range, but attributed to lymphoma, with clear involvement of the related organ, will be permitted; 9. Patient must have read, understood, and provided written informed consent after the nature of the study has been fully explained; 10. 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 a negative serum β-HCG pregnancy test conducted during screening (within 7 days of IMP administration); and 11. Men who may father a child must agree to the use of male contraception for the duration of their participation in the study. 12. Patients on corticosteriods must be tapered off the medication 2 weeks prior to MDX-060 administration and remain off corticosteriods until Day 106 |
|
E.4 | Principal exclusion criteria |
1. Previous treatment with any anti-CD30 antibody; 2. History of allogenic transplantation; 3. Any tumor lesion ≥ 10 cm in diameter; 4. Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease-free for at least 5 years is permissible; 5. Any significant active or chronic infection; 6. 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 to be enrolled in the study). Patients with a positive PPD who have received prophylaxis will be admitted into the study; 7. Pregnant or nursing; 8. Any underlying medical condition which, in the Principal Investigator’s opinion, will make the administration of IMP hazardous or obscure the interpretation of adverse events; or 9. Concomitant chemotherapy, systemic steroids, investigational agents, other anti-HD biologics, or radiation therapy. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Best objective response rate up to Day 106 (or any prior timepoint during the study if adequate information is available to make the determination) as determined by the Response Criteria for Non-Hodgkin's Lymphoma.
|
|
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 | Yes |
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 | Yes |
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
|
The study will terminate 2 years after the last patient enrolled has received the last dose of MDX-060. |
|
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 |