Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

JRCT ID: jRCT2031200161

Registered date:16/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Squamous Cell Carcinoma of the Head and Neck
• Date of first enrollment: 21/10/2020
• Target sample size: 370
• Study type: Interventional
• Intervention(s): Monalizumab, Cetuximab

Outcome(s)

• Primary Outcome: Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set

Secondary Outcome

- Overall Survival in Full Analysis Set (FAS)
- Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment in HPV-unrelated Analysis Set
- Progression-Free Survival Per RECIST 1.1 by Investigator Assessment in FAS
- Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set
- Percentage of Participants With OR Per RECIST 1.1 in FAS
- Duration of Response (DoR) Per RECIST 1.1 in HPV-unrelated Analysis Set
- Duration of Response Per RECIST 1.1 in FAS
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
- Number of Participants With Abnormal Vital Signs Reported as TEAEs
- Number of Participants With Electrocardiograms (ECGs) Reported as TEAEs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Are aged 18 years and over

- Recurrent or metastatic squamous cell carcinoma of the SCCHN, oral cavity, oropharynx, hypopharynx, or larynx which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy

- Received prior treatment using a programmed cell death ligand-1 (PD-L1) inhibitor

- Prior platinum failure

- Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN

- Has measurable disease per RECIST 1.1

- A fresh or recently acquired tumor tissue for the purpose of biomarker testing

- World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclude criteria

- Head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies

- Had prior cetuximab therapy (unless it was administered in curative locally advanced setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose)

- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis

- Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT04590963