NL-OMON52820
Completed
Phase 2
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) - 209229 (INDUCE-3)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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
Outcomes
Primary Outcomes
Not specified
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