plaveiselcelcarcinoom van hoofd-halsgebied Head and neck cancer
Conditions
Interventions
Treatment with pembrolizumab plus GSK3359609 or pembrolizumab plus placebo.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >=18 years. • Histological or cytological documentation of HNSCC that was diagnosed as recurrent or metastatic and considered incurable by local therapies. • Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx. • No prior systemic therapy administered in the recurrent or metastatic setting. See protocol chapter 5.1, item 5 for exceptions. • Measurable disease. • ECOG 0 or 1. • Adequate organ function. See protocol chapter 5.1, item 8 for details. • Life expectancy at least 12 weeks. • Contraception for females and males as stated in chapter 5.1 items 10-11 of the protocol. • Tumor tissue at screening as defined in chapter 5.1 item 12 of the protocol. • PD-L1 IHC CPS >=1 status. See also chapter 5.1 item 13 of the protocol. • Have results from testing of HPV status for oropharyngeal cancer
Exclusion criteria
Exclusion criteria: • Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent. • Systemic anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. • High risk of bleeding. See protocol chapter 5.2, item 3 for details. • Active tumor bleeding. • Grade 3/4 hypercalcemia. • Transfusion of blood products or administration of CSF within 14 days prior to randomization. See protocol chapter 5.2, item 8 for details. • CNS metastases. See protocol chapter 5.2, item 9 for details. • Autoimmune disease or syndrome that required systemic treatment within the past 2 years. See protocol chapter 5.2, item 11 for details. • Immunodeficiency or systemic steroids (>=10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization. See protocol chapter 5.2, item 12 for details. • Live vaccine within 30 days prior randomization. • Prior allogeneic/autologous bone marrow or solid organ transplantation. • Pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents. See protocol chapter 5.2, item 15 for details. • Gastrointestinal problems in the past 6 months. See protocol chapter 5.2, item 17 for details. • Allergen desensitization therapy within 4 weeks of randomization. • Cardiac abnormalities within the 6 months prior to randomization. See protocol chapter 5.2, item 19 for details. • Cirrhosis or current unstable liver or biliary disease. See protocol chapter 5.2, item 20 for details. • Pregnant, breastfeeding, or planning to become pregnant or father children during the study treatment or within 120 days after the last dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS, progression free survival (PSF). | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, ORR, disease control rate (DCR), duration of response (DOR), OS at 1 and 2 years, adverse events, dose modification, EORTC QLQ-H&N35, time to deterioration in physical function (PROMIS PF 8c). | — |
Countries
Netherlands
Outcome results
None listed