A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (study 209229)
- Conditions
- plaveiselcelcarcinoom van hoofd-halsgebiedHead and neck cancer
- Registration Number
- NL-OMON52820
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
• 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
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>OS, progression free survival (PSF).</p><br>
- Secondary Outcome Measures
Name Time Method <p>PFS, ORR, disease control rate (DCR), duration of response (DOR), OS at 1 and 2<br /><br>years, adverse events, dose modification, EORTC QLQ-H&N35, time to<br /><br>deterioration in physical function (PROMIS PF 8c).</p><br>