PEMBROLIZUMAB for Nasopharyngeal carcinoma (recurrent/metastatic, platinum-resistant)

Inclusion criteria

• {"criterion_text":"- Male/female participants who are at least 18 years old"}
• {"criterion_text":"- Adequate organ function as defined in the following table (Table 5.1). Specimens must be collected within 10 days prior to the start of study treatment."}
• {"criterion_text":"- The participant (or legally acceptable representative) provides written informed consent."}
• {"criterion_text":"- Histologically confirmed diagnosis of nasopharyngeal carcinoma."}
• {"criterion_text":"- Disease not amenable of surgical resection or irradiation with curative intent."}
• {"criterion_text":"- Disease progressing within 6 months since previous platinum-based systemic treatment (as concomitant to RT or as first line treatment for RM NPC)."}
• {"criterion_text":"- Male participants: A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:o Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR o A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 6 months after the last dose of study treatment."}
• {"criterion_text":"- Measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the start of study treatment."}
• {"criterion_text":"- Patients must have a life expectancy ≥ 16 weeks."}

Exclusion criteria

• {"criterion_text":"- WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required."}
• {"criterion_text":"- Severe hypersensitivity (≥Grade 3) to study treatment drugs and/or any of its excipients."}
• {"criterion_text":"- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)."}
• {"criterion_text":"- Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation."}
• {"criterion_text":"- Prior radiotherapy within 2 weeks of study intervention beginning. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease."}
• {"criterion_text":"- Received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed."}
• {"criterion_text":"- Currently participating in or has participated in a study with an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention."}
• {"criterion_text":"- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug."}
• {"criterion_text":"- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years."}
• {"criterion_text":"- Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided those are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention."}

Primary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR) as Assessed by Investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 by the 3rd radiological examination (week 27). ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.","definition_or_measurement_approach":"Assessed by investigators per RECIST 1.1 at the 3rd radiological examination (week 27). ORR = percentage of participants with CR or PR as defined by RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- Rate of patients with adverse events grade >= 3 and all grade adverse events classified according to the CTCAE v5.0","definition_or_measurement_approach":"Adverse events graded and reported according to CTCAE v5.0; rate calculated for grade ≥3 and for all grades."}
• {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":"PFS is defined as the time from first dose to the first documented progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions with an absolute increase of ≥5 mm; appearance of one or more lesions is also considered PD."}
• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"OS is defined as the time from first dose to death due to any cause. Patients alive or lost to follow-up are censored. Follow-up will continue at most 3 years since last patient first visit."}
• {"endpoint_text":"- Change in the Quality-of-Life (QoL) since Baseline Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43)","definition_or_measurement_approach":"QoL measured using the EORTC QLQ-HN43 questionnaire comparing change from baseline."}

Italy

Earliest CTIS Part Ii Submission Date

12-03-2024

Latest Decision Or Authorization Date

16-10-2024

Processing Time Days

218

Number Of Sites

10

Number Of Participants

30

Primary sponsor

Full Name

Fondazione GONO Plus

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Italy