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Official Title
An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase
Phase 2
Sponsor
Flamingo Therapeutics NV
Enrollment
81
Timeline
May 2023 → May 2026
About This Study
Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.
Eligibility Criteria
Inclusion Criteria
- 1Must have given written informed consent (signed and dated).
- 2Aged ≥18 years at the time of informed consent.
- 3Recurrent/metastatic histologically or cytologically proven squamous cell carcinoma of the head and neck that is considered incurable by local therapy. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- 4Presence of measurable tumor per RECIST v1.1 criteria.
- 5Detectable PD-L1 expression in tumor, defined as CPS ≥1 determined by a FDA or national regulatory agency of the country in which the patient resides.-approved test.
- 6Baseline fresh tumor biopsy or archival specimen.
- 7ECOG performance status of 0 or 1.
- 8Adequate organ function within 10 days of study treatment,
- 9Oxygen saturation on room air ≥92% by pulse oximetry.
- 10Females must be non-pregnant and non-lactating and either be postmenopausal or agree to adequate birth control.
- 11Males must be surgically sterile or agree to adequate birth control.
- 12Has an estimated life expectancy of at least 3 months.
- 13Has recovered from all complications or surgery and all toxicities of prior therapy
Exclusion Criteria
- 1Prior therapy for metastatic HNSCC.
- 2Has disease suitable for local therapy with curative intent.
- 3Primary tumor of the nasopharynx.
- 4Has received prior therapy with an anti-programmed death 1 (PD-1), anti PD L1, or anti-programmed death-ligand-2 (PD-L2).
- 5Radiation therapy (or other non-systemic therapy) within 2 weeks of Day 1 of study treatment.
- 6Known autoimmune disease that has required systemic treatment
- 7Known immunodeficiency or receiving systemic steroid therapy that would be the equivalent of \>10 mg prednisone daily
- 8Prior allogeneic tissue/solid organ transplant.
- 9Has significant cardiovascular disease
- 10Has received a live vaccine within 30 days
- 11Active infection requiring systemic antiviral or antimicrobial therapy
- 12History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- 13History of other malignancies
- 14Active HIV infection except patients who are currently stable on antiretroviral therapy for at least 4 weeks
- 15Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- 16Treated or untreated parenchymal brain metastases or leptomeningeal disease.
- 17Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent (if known), whichever is longer.
- 18Hypersensitivity to any component of danvatirsen or pembrolizumab.
Locations
32 sites participating in this study
Emory University Hospital Midtown
Atlanta, Georgia 30308
Study Coordinator
The University of Arizona Cancer Center
Tucson, Arizona 85719
Study Coordinator
University of California Irvine (UCI)
Irvine, California 92617
Clinical Research Manager
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →