Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Active:	No
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT02605967
Trial Phases:	Phase II	Protocol IDs:
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT02605967

Summary

The purpose of this randomized controlled Phase II study is to assess the efficacy of
PDR001 versus investigator's choice of chemotherapy in patients with advanced
nasopharyngeal carcinoma (NPC).

By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to
the activation of a T-cell mediated antitumor immune response.

Objectives

This was an open-label, multi-center, randomized, and controlled Phase II study to
evaluate the efficacy and safety of spartalizumab versus investigator's choice of
treatment in subjects with moderately differentiated/undifferentiated locally advanced
recurrent or metastatic NPC who progressed on or after first-line treatment.

Participants who met the inclusion/exclusion criteria were randomized in a 2:1 ratio to
either investigational arm (spartalizumab) or control arm (commonly used chemotherapy as
per investigator's choice). Participants treated with spartalizumab could continue
treatment until confirmed progressive disease as per immune-related response criteria
(irRC). Participants in the chemotherapy arm were allowed to crossover to spartalizumab
if they had radiological progression as per Response Evaluation Criteria In Solid Tumors
version 1.1 (RECIST v1.1) documented by an independent central review and the
Investigator believed this was the best treatment option for the patient.

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