An interventional study of PDR001 in adult patients with nasopharyngeal carcinoma (NPC) who have progressed on standard treatment

Phase 1

• Conditions: Moderately differentiated/undifferentiated locally advanced recurrent or metastatic nasopharyngeal carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000454-38-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-19
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

1. Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC.
2. Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting).
3. May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
4. 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.
5. At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
6. 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.
7. 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).

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

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

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified