E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Ovarian Cancer |
Metastatisk ovariecancer |
|
E.1.1.1 | Medical condition in easily understood language |
Ovarian Cancer |
Æggestokkræft |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033130 |
E.1.2 | Term | Ovarian cancer NOS |
E.1.2 | System Organ Class | 100000004864 |
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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 |
To evaluate toxicity (according to CTCAE version 4.0) and feasibility. |
At evaluere bivirkninger (ifølge CTCAE version 4.0) og gennemførlighed. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate treatment related immune responses To evaluate clinical response (according to RECIST 1.1 - response rate, progressionfree survival and overall survival) |
At evaluere behandlingsrelateret immunresponser At evaluere klinisk respons (ifølge RECIST 1.1 - responsrate, progressionsfri overlevelse og samlet overlevelse) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histological proven advanced ovarian cancer with the possibility of surgical removal of tumor tissue of > 1 cm3. Histology must be high grade serous carcinoma. 2. Progressive or recurrent resistant disease after platin-based chemotherapy or progressive or recurrent disease after second line or additional chemotherapy 3. Age: 18 – 70 years 4. ECOG performance status of ≤1 5. Life expectancy of > 6 months 6. At least one measurable parameter in accordance with RECIST 1.1 –criteria’s 7. No significant toxicities or side effects (CTC ≤ 1) from possible previous treatments, except sensoric- and motoric neuropathy (CTC ≤ 2) and/or alopecia (CTC ≤ 2). 8. Sufficient organ function. 9. Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment. 10. Signed statement of consent after receiving oral and written study information 11. Willingness to participate in the planned controls and capable of handling toxicities. |
1. Histologisk verificeret metastatisk ovariecancer, hvor det er muligt kirurgisk at fjerne tumorvæv på > 1 cm3. Histologien skal være high-grade serøst adenokarcinom. 2. Progressiv eller tilbagevendende sygdom resistent overfor platin-baseret kemoterapi eller progressiv eller tilbagevendende sygdom efter anden linie eller yderligere kemoterapi. 3. Alder 18-70 år 4. ECOG performance status 0 eller 1. 5. Forventet overlevelse på > 6 måneder. 6. Mindst et målbart parameter i henhold til RECIST 1.1 kriterierne. 7. Ingen signifikant toxicitet eller bivirkninger (CTC 0 ≤ 1) fra mulige tidligere behandlinger, undtagen sensorisk- og motorisk neuropati (CTC ≤ 2) og/eller alopeci (CTC ≤ 2). 8. Sufficient organfunktion. 9. Kvinder i den fertile alder skal benytte sikker antikonception. Dette gælder fra inklusion til 6 måneder efter behandlingen. 10. Underskrevet informeret samtykke efter mundtlig og skriftlig forsøgsinformation. 11. Patienten skal være villig til at deltage i de planlagte kontroller og i stand til at håndtere toxicitet. |
|
E.4 | Principal exclusion criteria |
1. Patients with other cancers within 5 years. 2. Known hypersensitivity to one of the active drugs or one or more of the excipients. 3. Serious comorbidity or autoimmune disease. 4. Creatinine clearence < 70 ml/min (in selected cases it can be decided to include patients with a lower GFR with the use of a reduced dose of chemotherapy). 5. Acutte/chronic infection with HIV, hepatitis, tuberculosis among others. 6. Severe allergies or previous anaphylactic reactions. 7. Pregnant women and women breastfeeding. 8. Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, metothrexate among others). 9. Simultaneous treatment with other experimental drugs. 10. Simultaneous treatment with other systemic anti-cancer treatments. 11. Patients with active and uncontrollable hypercalcaemia. |
1. Patienter med anden cancer indenfor 5 år. 2. Kendt hypersensitivitet til et af de aktive stoffer eller en/flere af hjælpestofferne. 3. Alvorlig komorbiditet eller autoimmun sygdom. 4. Creatinin clearance < 70 ml/min (i udvalgte tilfælde kan det blive besluttet at inkludere patienter med lavere GFR og give en reduceret dosis kemoterapi. 5. Akut/kronisk infektion med HIV, hepatitis, tuberkulose blandt andre. 6. Alvorlige allergier eller tidligere anafylaktiske reaktioner. 7. Gravide kvinder og kvinder der ammer. 8. Samtidig behandling med systemiske immunsupprimerende stoffer (herunder prednisolon, methotrexat blandt andre). 9. Samtidig behandling med andre eksperimentelle stoffer. 10. Samtidig behandling med andre systemiske anti-cancer behandlinger. 11. Patienter med aktiv og ukontrollerbar hypercalcæmi. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is toxicity (according to CTCAE 4.0). |
Det primære endepunkt er bivirkninger (ifølge CTCAE 4.0). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint will be evaluated before treatment, during treatment and at follow-up visits untill 6 months after treatment. |
Det primære endepunkt vil blive evalueret før behandling, under behandling og ved opfølgende besøg op til 6 måneder efter behandling. |
|
E.5.2 | Secondary end point(s) |
Secondary endpoints are treatment related immune response and clinical response (according to RECIST 1.1 - response rate, progressionfree survival and overall survival). |
Sekundære endepunkter er behandlingsrelateret immunrespons og klinisk respons (ifølge RECIST 1.1 - responsrate, progressionsfri overlevelse og samlet overlevelse). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoints will be evaluated after all patients have received treatment and clinical response is evaluated. Estimated 1 year after treatment of last patient. |
De sekundære endepunkter vil blive evalueret efter at alle patienter har modtaget behandling og klinisk respons er vurderet. Estimeret 1 år efter sidste patients behandling. |
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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 | No |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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
|
LVLS |
Sidste patients sidste besøg. |
|
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 |