Phase II, open label, single arm study of PembrolizumAb combiNeD with cisplatin or carbOplatin and etoposide in treatment naïve advanced meRkel cell cArcinoma (MCC) (PANDORA Trial).

Conditions

Advanced, naïve, Merkel cell carcinomas

Brief summary

ORR, that will be defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria

Detailed description

Incidence of Serius Adverse Events (SAE), Incidence and severity of Immune-mediated Adverse Events (imAE), Incidence and severity of Adverse Events (AEs) according to NCI Common Terminology criteria Adverse Event (CTCAE), version 5.0, Overall Survival (OS) that will be measured from the date of starting therapy to the date of death by any cause, Progression Free Survival (PFS) that will be measured from the date of starting therapy to the date of disease progression or death., Duration of Response (DOR) that will be measured from the date of the first response to disease progression or death in those patients who achieved a CR o PR during study treatment

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCISPLATINO SANDOZ

DRUGEtoposide Sandoz 20 mg/ml – Concentrato per soluzione per infusione

DRUGCARBOPLATINO TEVA 10 mg/ml concentrato per soluzione per infusione

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR, that will be defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria	—

Secondary

Measure	Time frame
Incidence of Serius Adverse Events (SAE), Incidence and severity of Immune-mediated Adverse Events (imAE), Incidence and severity of Adverse Events (AEs) according to NCI Common Terminology criteria Adverse Event (CTCAE), version 5.0, Overall Survival (OS) that will be measured from the date of starting therapy to the date of death by any cause, Progression Free Survival (PFS) that will be measured from the date of starting therapy to the date of disease progression or death., Duration of Response (DOR) that will be measured from the date of the first response to disease progression or death in those patients who achieved a CR o PR during study treatment	—

Measure

Time frame

Incidence of Serius Adverse Events (SAE), Incidence and severity of Immune-mediated Adverse Events (imAE), Incidence and severity of Adverse Events (AEs) according to NCI Common Terminology criteria Adverse Event (CTCAE), version 5.0, Overall Survival (OS) that will be measured from the date of starting therapy to the date of death by any cause, Progression Free Survival (PFS) that will be measured from the date of starting therapy to the date of disease progression or death., Duration of Response (DOR) that will be measured from the date of the first response to disease progression or death in those patients who achieved a CR o PR during study treatment

—

Countries

Italy

Outcome results

None listed