A Phase 2 clinical study to assess efficacy of induction carboplatin/paclitaxel + pembrolizumab for locoregionally advanced penile cancer: PRIAM

Conditions

locoregionally advanced penile cancer

Brief summary

Efficacy, defined as pathological complete response (pCR) in all patients who are evaluable for response

Detailed description

All-grade toxicity and treatment-related grade 3/4 toxicity by NCI-CTC-V5 will be reported in all patients who received at least one cycle of treatment, Progression-free survival, measured from day 1 of study therapy in all patients who were registered for the study and started treatment.  Overall survival, measured from day 1 of study therapy, in all patients who were registered for the study and started treatment., Overall survival, measured from day 1 of study therapy, in all patients who were registered for the study and started treatment., PFS and OS will be assessed at the primary analysis and at any later time point. Survival data will be reported as Kaplan-Meier curves. Additionally, median PFS or OS and PFS or OS at fixed time points (eg 1,2 or 3 years) may be reported.

Related papers

No related papers found yet.

Interventions

DRUGPaclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

DRUGCarboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Efficacy, defined as pathological complete response (pCR) in all patients who are evaluable for response	—

Secondary

Measure	Time frame
All-grade toxicity and treatment-related grade 3/4 toxicity by NCI-CTC-V5 will be reported in all patients who received at least one cycle of treatment, Progression-free survival, measured from day 1 of study therapy in all patients who were registered for the study and started treatment.  Overall survival, measured from day 1 of study therapy, in all patients who were registered for the study and started treatment., Overall survival, measured from day 1 of study therapy, in all patients who were registered for the study and started treatment., PFS and OS will be assessed at the primary analysis and at any later time point. Survival data will be reported as Kaplan-Meier curves. Additionally, median PFS or OS and PFS or OS at fixed time points (eg 1,2 or 3 years) may be reported.	—

Measure

Time frame

All-grade toxicity and treatment-related grade 3/4 toxicity by NCI-CTC-V5 will be reported in all patients who received at least one cycle of treatment, Progression-free survival, measured from day 1 of study therapy in all patients who were registered for the study and started treatment.  Overall survival, measured from day 1 of study therapy, in all patients who were registered for the study and started treatment., Overall survival, measured from day 1 of study therapy, in all patients who were registered for the study and started treatment., PFS and OS will be assessed at the primary analysis and at any later time point. Survival data will be reported as Kaplan-Meier curves. Additionally, median PFS or OS and PFS or OS at fixed time points (eg 1,2 or 3 years) may be reported.

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Countries

Belgium, Netherlands

Outcome results

None listed