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

Novartis

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Investigator choice of chemotherapy; Drug: Spartalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02605967

CPDR001X2201

2015-000454-38 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC.
• Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting).
• May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
• An archival tumor specimen or newly obtained tumor sample may be submitted at screening/baseline (a fresh tumor sample is preferred), unless agreed differently between Novartis and the Investigator.
• At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
• Prior treated brain or meningeal metastases must be without MRI evidence of progression for at least 8 weeks and off systemic steroids for at least 2 weeks prior to screening/baseline.
• Patient must be willing to undergo testing for human immunodeficiency virus (HIV) if not tested within the past 6 months. If HIV+ positive, patient will be eligible if: his/ her CD4+ count ≥ 300/μL; his/her viral load is undetectable; he/she is currently receiving highly active antiretroviral therapy (HAART).

Exclusion criteria

• History of severe hypersensitivity reactions to other mAbs
• Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators.
• Active HBV or HCV infections requiring therapy.
• Prior PD-1- or PD-L1-directed therapy or any therapeutic cancer vaccine.
• Patients receiving systemic treatment with any immunosuppressive medication.
• Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

122 participants in 2 patient groups

Spartalizumab 400 mg Q4W

Experimental group

Description:

anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab

Treatment:

Drug: Spartalizumab

Chemotherapy

Active Comparator group

Description:

commonly used chemotherapy as per investigator's choice

Treatment:

Drug: Investigator choice of chemotherapy