| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Muscle Invasive Bladder Cancer |
| Tumore alla vescica muscolo-invasivo (MIBC) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Muscle Invasive Bladder Cancer |
| Tumore alla vescica muscolo-invasivo (MIBC) |
|
| 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 | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10005003 |
| E.1.2 | Term | Bladder cancer |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| 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 |
1. To compare pathologic complete response (pCR) rates obtained in Arm A (preoperative pembrolizumab + neoadjuvant chemotherapy + Radical Cystectomy (RC) + Pelvic Lymph Node Dissection [PLND]) and Arm B (preoperative placebo + neoadjuvant chemotherapy + RC+ PLND), based on central pathology review, in participants whose tumors express programmed death ligand 1 (PD-L1) combined positive score (CPS) >=10 and in all participants, irrespective of CPS score.
2. To compare event-free survival (EFS) between Arm A (perioperative pembrolizumab + neoadjuvant chemotherapy + RC + PLND) and Arm B (perioperative placebo + neoadjuvant chemotherapy + RC + PLND), evaluated in participants whose tumors express PD-L1 CPS >=10 and in all participants, irrespective of CPS score. |
1. Confrontare i tassi di risposta patologica completa (pathologic complete response, pCR) ottenuti nel braccio A (uso preoperatorio di pembrolizumab + chemioterapia neoadiuvante + cistectomia radicale (CR) + dissezione dei linfonodi pelvici Pelvic Lymph Node Dissection, [PLND]) e nel braccio B (uso preop. di placebo + chemiot. neoadiuv. + CR + PLND), in base alla revisione della patologia a livello centrale, nei sogg. con tumori che esprimono il ligando1 di morte programmata (programmed death ligand 1, PD-L1) con punteggio positivo combinato (combined positive score, CPS) >=10 e in tutti i sogg., indip. dal punteggio CPS.
2. Confrontare la sopravvivenza libera da eventi (event-free survival, EFS) tra il braccio A (uso perioperatorio di pembrolizumab + chemioterapia neoadiuvante + CR + PLND) e il braccio B (uso perioperatorio di placebo + chemioterapia neoadiuvante + CR + PLND), valutata nei sogg. con tumori che esprimono PD-L1 CPS >=10 e in tutti i sogg., indip. dal punteggio CPS. |
|
| E.2.2 | Secondary objectives of the trial |
1. To compare the overall survival (OS) between Arm A and Arm B, evaluated in participants whose tumors express PD-L1, CPS >=10 and all participants, irrespective of CPS score.
2. To assess disease-free survival (DFS) in participants from Arm A and Arm B, who are disease free after surgery based on participants whose tumors express PD-L1, CPS >=10 and all participants, irrespective of CPS score.
3. To compare the rate of pathologic downstaging (pDS) between Arm A and Arm B, evaluated in participants whose tumors express PD-L1, CPS >=10 and all participants, irrespective of CPS score.
4. To evaluate the safety and tolerability of pembrolizumab + chemotherapy + RC + PLND. |
1 Confrontare la sopravvivenza globale (overall survival,OS) tra il braccio A (uso periop. di pembr.+chem. neoadiuv.+CR+PLND) e il braccio B (uso periop. di plac.+chem. neoadiuv.+CR+PLND), valutata nei sogg. con tumori che esprimono PD-L1 CPS>=10 e in tutti i sogg., indip. dal punt. CPS
2 Valutare la sopravv. libera da malattia (disease-free survival.DFS) nei sogg. del br. A (uso periop. di pembr.+chem. neoadiuv.+CR+PLND) e del br. B (uso periop. di plac.+chem. neoadiuv.+CR+PLND), che siano liberi da malattia dopo l’interv. chir., sulla base dei sogg. con tumori che espr. PD-L1 CPS>=10 e tutti i sogg., indip. dal punt. CPS
3 Confrontare il tasso di regress. dello stadio patologico (pathologic downstaging,pDS) tra il br. A (uso preop. di pembr.+chem. neoadiuv.+CR+PLND) e il br. B (uso preop. di plac.+chem. neoadiuv.+CR+PLND), valutato nei sogg. con tumori che espr. PD-L1 CPS>=10 e in tutti i sogg., indip. dal punt. CPS
4 Valutare la sicurezza e la tollerabilità di pembr.+ chem.+CR+PLND |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Other types of substudies
Specify title, date and version of each substudy with relative objectives: Merck will conduct Future Biomedical Research on DNA (blood and/or tissue and/or others specimens) collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
|
Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Merck condurrà una Ricerca Biomedica Futura su campioni di DNA (sangue e/o tessuti e/o altri campioni) raccolti nel corso di questo studio clinico. Tale ricerca ha lo scopo di esaminare vari biomarcatori per rispondere a domande che stanno emergendo e che non sono descritte in altre parti del protocollo (nell’ambito dello studio principale), e verrà condotta solo su campioni di soggetti che abbiano rilasciato apposito consenso.
L'obiettivo della raccolta dei campioni per la Ricerca Biomedica Futura è quello di esplorare e identificare biomarcatori che contribuiscano scientificamente alla comprensione delle malattie e/o della relative terapie. L'obiettivo ultimo è quello di utilizzare tali informazioni per sviluppare farmaci più sicuri e più efficaci, e/o per garantire che i soggetti ricevano la dose giusta del giusto farmaco al
momento giusto.
|
|
| E.3 | Principal inclusion criteria |
1. Have a histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (>=50%) urothelial histology (histology and presence of muscle invasion to be confirmed by BICR):
- Participants with mixed histology are eligible provided the urothelial component is >=50% as noted above.
- Participants whose tumors contain any neuroendocrine component are not eligible.
- Urothelial carcinomas not originating from the bladder (eg, upper tract [ureters, renal pelvis], urethra) are not eligible.
2. Have clinically non-metastatic bladder cancer (N0M0) determined by imaging (CT chest and CT or MRI of the abdomen/pelvis), confirmed by BICR.
3. Be deemed eligible for RC + PLND by his/her urologist and/or oncologist and agree to undergo curative intent standard RC + PLND (including prostatectomy if applicable) as per AUA/ASTRO/ASCO/SUO guidelines
4. Have a transurethral resection (TUR) of a bladder tumor (obtained within 60 days prior to enrollment [ICF signed]) that is submitted and adequate to determine histology, muscle invasion, and PD-L1 status by central pathology vendor. In the event the sample is not evaluable for PD-L1, the participant will be assigned to the CPS <10 group for stratification.
5. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Have demonstrated adequate organ function (all screening labs should be performed within 14 days prior to randomization).
7. Participant is male or female and at least 18 years of age inclusive, at the time of signing the informed consent.
8. A male participant must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 180 days (corresponding to time needed to eliminate any study treatment(s) [pembrolizumab and or any active combination] plus an additional 90 days [a spermatogenesis cycle] for study treatments where there is risk of clinically relevant genotoxicity) after the last dose of study treatment and refrain from donating sperm during this period.
9. A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least 1 of the following conditions applies:
a. Not a woman of childbearing potential (WOCBP)
b. WOCBP who agrees to follow the contraceptive guidance:Contraceptive Guidance and Pregnancy Testing during the treatment period and for at least 180 days (corresponding to time needed to eliminate any study treatment(s) [pembrolizumab and or any active combination] plus 30 days [a menstruation cycle] for study treatments with risk of genotoxicity) after the last dose of study treatment.
10. The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research. |
1. Presentare diagnosi istologicamente confermata di tumore della vescica muscolo-invasivo (T2-T4aN0M0) con istologia uroteliale predominante (>=50%) (istologia e presenza di invasione muscolare da confermare mediante BICR):
- I soggetti con istologia mista sono idonei a condizione che la componente uroteliale sia >=50% come indicato sopra.
- I soggetti con tumori contenenti qualsiasi componente neuroendocrina non sono idonei.
- I carcinomi uroteliali che non hanno origine dalla vescica (ad es. tratto superiore [ureteri, pelvi renale], uretra) non sono idonei.
2. Presentare un tumore della vescica clinicamente non metastatico (N0M0) determinato mediante diagnostica per immagini (TC del torace e TC o RMI di addome/pelvi) e confermato mediante BICR.
3. Essere considerato idoneo a CR + PLND dall’urologo e/o dall’oncologo e accettare di sottoporsi a CR + PLND standard con intento curativo (inclusa la prostatectomia, se applicabile) secondo le linee guida AUA/ASTRO/ASCO/SUO indicate nell’Appendice 9 (Sezione 10.9 del protocollo).
4. Essere stato sottoposto a resezione transuretrale (transurethral resection, TUR) di un tumore della vescica (nei 60 giorni precedenti l’arruolamento [ICF firmato]) che sia stata presentata e risulti adatta a determinare l’istologia, l’invasione muscolare e lo stato di PD-L1 da parte del servizio di patologia centrale. Nel caso in cui il campione sia non valutabile per PD-L1, il soggetto verrà assegnato al gruppo CPS <10 gruppo per la stratificazione.
5. Avere uno stato di validità di 0 o 1 in base alla scala Gruppo Cooperativo Orientale di Oncologia (Eastern Cooperative Oncology Group, ECOG).
6. Dimostrare una funzionalità d’organo adeguata (tutti gli esami di laboratorio di screening devono essere eseguiti nei 14 giorni precedenti la randomizzazione).
7. Il soggetto è un soggetto di sesso maschile o femminile di almeno 18 anni di età al momento della firma del consenso informato.
8. I soggetti di sesso maschile devono accettare di usare uno dei metodi contraccettivi indicati nell’Appendice 5 di questo protocollo durante il periodo del trattamento e per almeno 180 giorni (che corrispondono al tempo necessario per eliminare qualsiasi trattamento dello studio [pembrolizumab e/o qualsiasi combinazione attiva], più altri 90 giorni [un ciclo di spermatogenesi] per i trattamenti dello studio che prevedono un rischio di genotossicità rilevante) dopo l’ultima dose del trattamento dello studio ed evitare di donare lo sperma durante questo periodo.
Per i restanti criteri di inclusione fare riferimento alla sinossi. |
|
| E.4 | Principal exclusion criteria |
1. Has a known additional malignancy that is progressing or has required active anti-cancer treatment <=3years of study randomization
2. Has received any prior systemic anti-neoplastic treatment for MIBC.
3. Has an abdomino-pelvic lymph node >=15 mm in the short axis.
4. Is cisplatin-ineligible, as defined by meeting any one of the following criteria:
- Impaired renal function with measured or calculated creatinine clearance (CrCl) <60 mL/min (calculated by Cockcroft-Gault method or 24-hour urine collection).
- ECOG Performance Status >= 2
- CTCAE v.4 Grade >=2 audiometric hearing loss (threshold shift of >25 dB averaged at 2 consecutive test frequencies in at least 1 ear; testing is not required at screening; it may be performed at Investigator's discretion)
- CTCAE v.4 Grade >=2 peripheral neuropathy
- New York Heart Association (NYHA) Class III heart failure
5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PDL2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
6. Has received therapy with hematopoietic growth factor such as granulocyte-colony stimulating factor (G-CSF) or GM-CSF in 14 days prior to randomization.
7. Has received prior systemic anti-cancer therapy including investigational agents within 3 years of randomization.
8. Has received any prior radiotherapy to the bladder.
9. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
10. Is currently participating in or has participated in a study of an investigational agent orhas used an investigational device within 4 weeks prior to the first dose of study intervention.
11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
12. Has hypersensitivity to mAbs (including pembrolizumab) and/or any of their excipients.
13. Has severe hypersensitivity (=Grade 3) to cisplatin and/or gemcitabine and any of their excipients.
14. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy is not considered a form of systemic treatment and is allowed.
15. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
16. Has an active infection requiring systemic therapy. Participant may be rescreened once after resolution of the infection.
17. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health
authority
18. Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as detectable HCV RNA via qualitative nucleic acid testing) infection. Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
19. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
20. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Refer to protocol for the rest of exclusion criteria. |
1. Presenta una malignità nota che sia in fase di progressione o abbia richiesto un trattamento antitumorale attivo <=3 anni dalla randomizzazione dello studio.
2. Ha ricevuto qualsiasi precedente trattamento antineoplastico sistemico per MIBC.
Nota: è consentito un precedente trattamento per NMIBC con terapia a base di instillazione intra-vescicale, come BCG o chemioterapia intra-vescicale.
3. Presenta un linfonodo pelvico-addominale con asse corto >=15 mm.
4. Non è idoneo al cisplatino; tale condizione è definita in base al soddisfacimento di uno qualsiasi dei seguenti criteri:
- Compromissione della funzionalità renale con clearance della creatinina (CrCl) calcolata o misurata <60 ml/min (calcolata mediante metodo di Cockcroft-Gault o raccolta delle urine nell’arco di 24 ore).
- Stato di validità ECOG >= 2
- Perdita dell’udito audiometrico di grado >=2 secondo i criteri comuni di terminologia per gli eventi avversi (Common Terminology Criteria for Adverse Events, CTCAE) v.4 (soglia di scostamento >25 dB sulla media di 2 frequenze di test consecutive in almeno 1 orecchio; il test non è richiesto allo screening e può essere eseguito a discrezione dello sperimentatore).
- Neuropatia periferica di grado >=2 secondo i criteri CTCAE v.4.
- Insufficienza cardiaca congestizia di classe III in base all'Associazione di cardiologia di New York (New York Heart Association, NYHA)
5. Ha ricevuto una terapia precedente con un agente anti-PD-1, anti-PD-L1 o anti-PD-L2 o con un agente diretto contro un altro recettore stimolante o co-inibitorio delle cellule T (ad es. CTLA-4, OX-40, CD137).
6. Ha ricevuto una terapia con fattore di crescita ematopoietico, come il fattore stimolante le colonie di granulociti (granulocyte-colony stimulating factor, G-CSF) o il fattore stimolante le colonie di granulociti macrofagi (Granulocyte-Macrophage colony stimulating factor, GM-CSF) nei 14 giorni precedenti la randomizzazione.
7. Ha ricevuto una precedente terapia antitumorale sistemica, inclusi agenti sperimentali entro 3 anni dalla randomizzazione.
8. È stato precedentemente sottoposto a radioterapia alla vescica.
9. Ha ricevuto una vaccinazione con vaccino vivo nei 30giorni precedenti la prima dose di farmaco dello studio. Esempi di vaccini vivi comprendono, a titolo esemplificativo ma non esaustivo: morbillo, parotite, rosolia, varicella/zoster, febbre gialla, rabbia, bacillo di Calmette-Guérin (BCG) e vaccino tifoideo. I vaccini per l’influenza stagionale iniettabili in genere sono vaccini con virus inattivati e sono ammessi; tuttavia i vaccini antinfluenzali intranasali (ad es. Flu-Mist®) sono vaccini vivi attenuati e non sono consentiti.
Per i restanti criteri di esclusione fare riferimento alla sinossi. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Pathologic Complete Response Rate in All Participants
2. Pathologic Complete Response Rate in Participants Whose Tumors Express PD-L1, CPS >=10
3. Event-Free Survival in All Participants
4. Event-Free Survival in Participants Whose Tumors Express PD-L1, CPS >=10 |
1. Tasso di risposta patologica completa (pCR) in tutti i partecipanti
2. Tasso di pCR nei partecipanti i cui tumori esprimono PD-L1 CPS >=10
3. Sopravvivenza libera da eventi (EFS) in tutti i partecipanti
4. EFS nei partecipanti i cui tumori esprimono PD-L1 CPS >=10 |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 4 months (Time of surgery)
2. Up to approximately 4 months (Time of surgery)
3. Up to approximately 5.5 years
4. Up to approximately 5.5 years |
1. Fino a circa 4 mesi (Tempo di intervento)
2. Fino a circa 4 mesi (Tempo di intervento)
3. Fino a circa 5.5 anni
4. Fino a circa 5.5 anni |
|
| E.5.2 | Secondary end point(s) |
1. Overall Survival in All Participants
2. Overall Survival in Participants Whose Tumors Express PD-L1, CPS >=10
3. Disease-Free Survival in All Participants
4. Disease-Free Survival in Participants Whose Tumors Express PD-L1, CPS >=10
5. Pathologic Downstaging Rate in All Participants
6. Pathologic Downstaging Rate in Participants Whose Tumors Express PD- L1, CPS >=10
7. Percentage of Participants Experiencing Adverse Events (AEs)
8. Percentage of Participants Discontinuing Study Drug Due to an AE
9. Percentage of Participants Experiencing Perioperative Complications
10. Change in Patient-Reported Outcomes from Baseline in the Total Score of Functional Assessment of Cancer Therapy – General (FACT-G)
11. Change in Patient-Reported Outcomes from Baseline in the Total Score FACT B1-Cys
12. Change in Patient-Reported Outcomes from Baseline in FACT-B1-Cys-Trial Outcome Index (TOI)
13. Change in Patient-Reported Outcomes from Baseline in EQ-5D-5L Visual Analog Score (VAS)
14. Change in Patient-Reported Outcomes from Baseline in EQ-5D-5L Utility Score
15. Time to Deterioration (TTD) in FACT-G
16. Time to Deterioration in EQ-5D-5L VAS |
1. Sopravvivenza globale (OS) in tutti i partecipanti
2. OS nei partecipanti i cui tumori esprimono PD-L1 CPS >=10
3. Sopravvivenza libera da malattia (DFS) in tutti i partecipanti
4. DFS nei partecipanti i cui tumori esprimono PD-L1 CPS >=10
5. Tasso patologico di rallentamento (pDS) in tutti i partecipanti
6. Tasso pDS nei partecipanti i cui tumori esprimono PD-L1 CPS >=10
7. Percentuale di partecipanti che hanno manifestato un Evento Avverso (AE)
8. Percentuale di partecipanti che interrompono il trattamento in studio a causa di un Evento Avverso (AE)
9. Percentuale di partecipanti che hanno manifestato una complicazione perioperatoria
10. Variazioni negli esiti riferiti dal paziente rispetto al basale nel Total Score of Functional Assessment of Cancer Therapy – General (FACT-G)
11. Variazioni negli esiti riferiti dal paziente rispetto al basale nel Total Score FACT B1-Cys
12. Variazioni negli esiti riferiti dal paziente rispetto al basale nel FACT-B1-Cys-Trial Outcome Index (TOI)
13. Variazioni negli esiti riferiti dal paziente rispetto al basale nel EQ-5D-5L Visual Analog Score (VAS)
14. Variazioni negli esiti riferiti dal paziente rispetto al basale nel EQ-5D-5L Utility Score
15. Tempo al deterioramento (TTD) nel FACT-G
16. Tempo al deterioramento (TTD) nel EQ-5D-5L VAS |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 5.5 years
2. Up to approximately 5.5 years
3. From approximately 5 months up to approximately5.5 years
4. From approximately 5 months up to approximately5.5 years
5. Up to approximately 4 months (Time of surgery)
6. Up to approximately 4 months (Time of surgery)
7. Up to approximately 5.5 years
8. Up to approximately 1 year
9. Up to approximately 1 year
10. Up to approximately 5.5 years
11. Up to approximately 5.5 years
12. Up to approximately 5.5 years
13. Up to approximately 5.5 years
14. Up to approximately 5.5 years
15. Up to approximately 5.5 years
16. Up to approximately 5.5 years |
1. Fino a circa 5.5 anni
2. Fino a circa 5.5 anni
3. Da circa 5 mesi fino a circa 5.5 anni
4. Da circa 5 mesi fino a circa 5.5 anni
5. Fino a circa 4 mesi (Tempo di intervento)
6. Fino a circa 4 mesi (Tempo di intervento)
7. Fino a circa 5.5 anni
8. Fino a circa 1 anno
9. Fino a circa 1 anno
10. Fino a circa 5.5 anni
11. Fino a circa 5.5 anni
12. Fino a circa 5.5 anni
13. Fino a circa 5.5 anni
14. Fino a circa 5.5 anni
15. Fino a circa 5.5 anni
16. Fino a circa 5.5 anni |
|
| 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 | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | Yes |
| 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) | 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| 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 | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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 | 8 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 76 |
| 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 |
| Australia |
| Canada |
| Israel |
| Japan |
| Korea, Republic of |
| Mexico |
| Russian Federation |
| Thailand |
| Turkey |
| Ukraine |
| United States |
| Belgium |
| Denmark |
| France |
| Germany |
| Hungary |
| Ireland |
| Italy |
| Poland |
| Spain |
| Sweden |
| United Kingdom |
|
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 5 |
| E.8.9.1 | In the Member State concerned months | 5 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 5 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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