| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Recurrent/Metastatic HPV16 Cervical Cancer |
| Carcinoma della cervice ricorrente o metastatico causato da HPV16 |
|
| E.1.1.1 | Medical condition in easily understood language |
| Cervical Cancer due to Human Papilloma Virus Type 16 Infection |
| Carcinoma della cervice causato dal virus umano Papilloma tipo 16 |
|
| 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 | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10008229 |
| E.1.2 | Term | Cervical cancer |
| E.1.2 | System Organ Class | 100000004864 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10008231 |
| E.1.2 | Term | Cervical cancer recurrent |
| E.1.2 | System Organ Class | 100000004864 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10063001 |
| E.1.2 | Term | Human papilloma virus infection |
| E.1.2 | System Organ Class | 100000004862 |
|
| 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 the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). |
| L’obiettivo primario dello studio è stimare il beneficio clinico di cemiplimab + ISA101b a seguito di progressione su chemioterapia di prima linea, valutata dal tasso di risposta obiettiva (ORR). |
|
| E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are:
- To characterize the safety profile of cemiplimab + ISA101b
- To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS) |
Obiettivi secondari:
Gli obiettivi secondari dello studio sono:
-Caratterizzare il profilo di sicurezza di cemiplimab + ISA101b
-Valutare l’efficacia preliminare di cemiplimab + ISA101b misurata dalla durata della risposta (DoR), dalla sopravvivenza libera da progressione (PFS) e dalla sopravvivenza globale (OS) |
|
| 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: Information on the biomedical research and pharmacogenomics optional sub-studies are provided within the protocol.
-Biomedical Research (Optional Sub-Study)
The unused samples (biomarker, PK and ADA), may be utilized for future biomedical research. Future biomedical research may include assay development and/or validation, and the samples may be used as references or controls in unrelated experiments.
-Pharmacogenomics (Optional Sub-Study)
The purpose of the pharmacogenomic analyses is to identify genomic associations with clinical (safety or efficacy) or biomarker response to cemiplimab, clinical outcome measures, and possible AEs. In addition, associations between genomic variants and prognosis or progression of cervical cancer or related diseases may also be studied. These data may be used or combined with data collected from other studies to identify and validate genomic markers related to the study drug, target pathway, or cervical cancer and related diseases.
|
Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Le informazioni sui sottostudi facoltativi di ricerca biomedica e di farmacogenomica sono riportate nel protocollo.
-Ricerca biomedica (sottostudio facoltativo) I campioni inutilizzati (biomarcatori, P e ADA) potrebbero essere usati per ricerche biomediche future. Le ricerche biomediche future possono includere lo sviluppo e/o la validazione di saggi; i campioni potrebbero essere utilizzati con funzione di riferimento o controllo in esperimenti indipendenti.
-Farmacogenomica (sottostudio facoltativo). La finalità delle analisi farmacogenomiche è identificare le associazioni genomiche legate alla risposta clinica (sicurezza o efficacia) o dei biomarcatori a cemiplimab, nonché le misure di esito clinico e possibili AE. Inoltre, potrebbero essere studiate anche le associazioni tra le varianti genomiche e la prognosi o progressione del carcinoma della cervice o delle patologie correlate. I suddetti dati possono essere utilizzati o combinati con dati raccolti da altri studi al fine di identificare e validare i marcatori genomici correlati al farmaco in studio, al pathway target o al carcinoma della cervice e le patologie correlate.
|
|
| E.3 | Principal inclusion criteria |
1. Adult patients =18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
2. Has histologically confirmed recurrent or metastatic HPV16 positive squamous cell cervical cancer, who have experienced disease progression after treatment with platinum containing therapy as defined in the protocol
3. Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
4. Patient must have measurable disease as defined by RECIST 1.1.
5. ECOG performance status of 0 or 1.
6. Has adequate organ and bone marrow function as defined in the protocol.
7. Anticipated life expectancy =20 weeks.
Other protocol-defined Inclusion criteria apply |
1. Pazienti adulti di età =18 anni (o che hanno raggiunto l’età legale prevista dalle normative specifiche del Paese per poter acconsentire a partecipare a uno studio clinico).
2. Pazienti con carcinoma squamocellulare della cervice recidivante o metastatico HPV16 positivo confermato per via istologica, che hanno manifestato progressione di malattia successivamente al trattamento con un farmaco contenente platino, secondo la definizione del protocollo
3.Per i pazienti è necessario l’accertamento di positività per il genotipo HPV16; positività stabilita da un laboratorio centrale di riferimento specificato.
4. I pazienti devono avere una malattia misurabile, secondo RECIST 1.1.
5. Performance status ECOG 0 o 1.
6. Adeguata funzione di organi e midollo osseo, secondo la definizione del protocollo.
7. Aspettativa di vita stimata =20 settimane.
Si applicano ulteriori criteri di inclusione definiti dal protocollo |
|
| E.4 | Principal exclusion criteria |
1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
2. Prior treatment with other systemic immune-modulating agents as defined in the protocol
3. Major surgery or radiation therapy within 14 days of first administration of study drug
4. Has received treatment with an approved systemic therapy within 4 weeks of first dose of study drug, or has not yet recovered (ie, grade =1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol
5. Has another malignancy that is progressing or requires active treatment and/or history of malignancy other than cervical cancer within
3 years of date of first planned dose of study drug as defined in the protocol
6. Has any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 4 weeks prior to the first dose of study drug.
7. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
Other protocol-defined Exclusion criteria apply |
1. Precedente trattamento con un agente che blocca il pathway PD-1/PD-L1.
2. Precedente trattamento con altri agenti immunomodulanti sistemici, secondo la definizione del protocollo
3. Chirurgia maggiore o radioterapia entro 14 giorni dalla prima somministrazione del farmaco in studio
4. Paziente che ha ricevuto un trattamento con una terapia sistemica approvata entro 4 settimane dalla prima somministrazione del farmaco in studio, o non ha ancora recuperato (ossia grado =1 o basale) a seguito di eventuali tossicità acute fatta eccezione per le variazioni di laboratorio, secondo la descrizione del protocollo
5. Presenza di un’altra neoplasia maligna in progressione o che richiede un trattamento attivo e/o anamnesi di neoplasia maligna diversa dal carcinoma della cervice entro 3 anni dalla data della prima somministrazione di farmaco in studio programmata, secondo la definizione del protocollo
6. Presenza di una malattia che richiede terapia in atto/continua di corticosteroidi (>10 mg prednisone/die o equivalente antiinfiammatorio) entro 4 settimane precedenti la prima somministrazione del farmaco in studio.
7. Evidenza in corso o recente (entro 5 anni) di malattia autoimmune significativa che richiede trattamento con terapie immunosoppressive sistemiche, secondo la definizione del protocollo
Si applicano ulteriori criteri di esclusione definiti dal protocollo |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Objective response rate (ORR) |
| Tasso di risposta obiettiva (ORR) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Up to 36 months |
| fino a 36 mesi |
|
| E.5.2 | Secondary end point(s) |
1. Incidence and severity of treatment emergent adverse events (TEAEs)
2. Incidence and severity of adverse events of special interest (AESIs)
3. Incidence and severity of serious adverse events (SAEs)
4. Incidence and severity of = grade 3 laboratory abnormalities
5. Duration of response (DOR)
6. Progression free survival (PFS)
7. Overall survival (OS) |
1. Incidenza e severità di eventi avversi emergenti dal trattamento (TEAE)
2. Incidenza e severità di eventi avversi di interesse speciale (AESI)
3. Incidenza e severità di eventi avversi seri (SAE)
4. Incidenza e severità di anomalie di laboratorio di grado =3
5. Durata della risposta (DoR)
6. Sopravvivenza libera da progressione (PFS)
7. Sopravvivenza globale (OS) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-4: Up to 90 days after the last dose of study treatment
5-7: Up to 36 months |
1-4: Fino a 90 giorni dopo l'ultima somministrazione del trattamento in studio
5-7: Fino a 36 mesi |
|
| 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 | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| 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 | No |
| 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.8.2.4 | Number of treatment arms in the trial | 1 |
| 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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 12 |
| 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 |
| Brazil |
| Korea, Democratic People's Republic of |
| Russian Federation |
| United States |
| Belgium |
| Italy |
| Netherlands |
| Spain |
|
| 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
|
| Date of the last contact of the last patient in the study. |
| Data dell'ultimo contatto con l'ultima paziente |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 36 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 36 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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