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Study Keyword: PD-1

This is a two-part study of pembrolizumab (MK-3475) in paediatric participants who have any of the following types of cancer:

  • advanced melanoma (6 months to <18 years of age),
  • advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumour or other lymphoma (6 months to <18 years of age),
  • relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age) or
  • advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumours (6 months to <18 years of age) or
  • advanced relapsed or refractory tumour-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumours (6 months to <18 years of age)

Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the paediatric RP2D.

The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumour or other lymphoma; advanced, relapsed or refractory MSI-H solid tumour; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts.

With Amendment 8, enrolment of participants with solid tumours and participants aged 6 months to <12 years with melanoma were closed. Enrolment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrolment of participants with MSI-H and TMB-H solid tumours also continues.

Study Keyword: PD-1

A Study of Pembrolizumab in Paediatric Participants With an Advanced Solid Tumour or Lymphoma

March 10, 2022

By clique_admin

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer: advanced melanoma (6 months to

Study of Pembrolizumab Combination Therapies in Metastatic Castration-Resistant Prostate Cancer

March 7, 2022

By Support_Clique

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be nine cohorts

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma

March 7, 2022

By clique_admin

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in

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