NL-OMON49382
Completed
Not Applicable
A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 plus Tilsotolimod and Other Therapy Combinations in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma - M19-894
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AbbVie B.V.
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- At least 18 years old and weigh at least 35 kg
- •\- Eastern Cooperative Oncology Group performance status of 0 or 1 and a life
- •expectancy of \>\= 3 months
- •\- Have \>\= 1 lesion accessible for intratumoral injection and lesion(s) must be \>\=
- •2 cm in longest diameter.
- •\- Histologically or cytologically confirmed R/M HNSCC (of the following 4
- •subsites: oral cavity, oropharynx, larynx, and hypopharynx) who previously
- •progressed either during or after \<\= 3 prior treatment regimens administered in
- •the recurrent or metastatic setting. Must have received 1 immunotherapy regimen
- •which included a PD\-(L)1 inhibitor.
Exclusion Criteria
- •\- No uncontrolled metastases to the central nervous system (CNS). Subjects with
- •brain metastases are eligible provided that evidence of clinical and
- •radiographic stable disease for at least 4 weeks after definitive therapy is
- •given and subjects have not used prohibited levels of steroids for at least 4
- •weeks prior to first dose of the study.
- •\- Must not have received prior treatment with OX40 or TLR agonists (excluding
- •topical agents)
Outcomes
Primary Outcomes
Not specified
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