Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC (NCT04659369) | Clinical Trial Compass
TerminatedPhase 1
Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
Stopped: Difficult to recruit subjects
China21 participantsStarted 2020-09-24
Plain-language summary
The purpose of this study is to compare the pharmacokinetic, safety, immunogenicity and efficacy of CMAB819 and Nivolumab in subjects with recurrent or metastatic head and neck squamous cell carcinoma., after failure of prior platinum-based chemotherapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males or females, Aged ≥18 years and ≤75 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
✓. Life expectancy of at least 3 months.
✓. Histologically or cytologically confirmed recurrent or metastatic SCCHN (oropharynx, oral cavity, hypopharynx, larynx, etc.), Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
✓. Tumor tissue (archival or fresh biopsy specimen wthin 3 years) must be available for PD-L1 expression analysis.
✓. Subjects must have experienced disease recurrence or progression during or after last dose of platinum therapy for advanced or metastatic disease.
✓. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria.
✓. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 5.0) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll.
Exclusion criteria
✕. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal darcinoma, squamous carcinoma of unknown primary, salivary gland carcinoma, or cutaneous squamous cell carcinoma.
. Subjects with active CNS metastases and/or carcinomatous meningitis. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
✕. Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) within the previous 3 years are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
✕. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
✕. Subjects with immunodeficiency inculding testing positive for human immunodeficiency virus (HIV) , acquired or congenital immunodeficiency disease, or organ transplantation.
✕. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 （such as ipilimumab）antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
✕. Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
✕. Subjects with significant cardiovascular or cerebrovascular disease, such as dysrhythmias, conduction block, QTc interval at rest \> 480 ms, New York Heart Association cardiac disease Class II or greater, left ventricular ejection fraction (LVEF) \<50％, uncontrollable high blood pressures, or the following within 6 months prior to the first dosing: acute coronary syndrome, congestive heart-failure, aoreic dissection, stroke or any other Grade 3 or 4 adverse events of cardia and cerebrovascular disorder.