Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:
The clinical evidence base for Monalizumab comprises 61 peer-reviewed publications across 15 journals, 1 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Carcinoma, Non-Small-Cell Lung, Hematologic Neoplasms, Neoplasm Metastasis, and Head and Neck Neoplasms. Most recent publication: Implementation of the Study Participant Feedback Questionnaire to understand participant experience in a phase 3 oncology clinical trial., BMJ Open, 2025.
Curated set of pivotal-trial result papers and recent publications in high-tier journals.
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT04590963 INTERLINK-1 | Head and Neck Neoplasms | Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set Baseline (-28 to -1) through 17.5 months (maximum observed duration) | Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | 8.8 Months |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 8.6 Months |
1975–2025: 61 publications.
Monalizumab is being investigated for the treatment of various conditions, including certain types of cancer. One key study, INTERLINK-1 (NCT04590963), focused on patients with Head and Neck Neoplasms, specifically those with Human Papillomavirus (HPV)-unrelated disease. The primary outcome measured in this trial was Overall Survival (OS).
In the HPV-unrelated analysis set of NCT04590963, Overall Survival was observed from baseline through a maximum of 17.5 months. Patients receiving Monalizumab 750 mg Q2W in combination with Cetuximab 400 mg/m^2 had a median Overall Survival of 8.8 Months. For patients in the comparator arm, who received Placebo Q2W along with Cetuximab 400 mg/m^2, the median Overall Survival was 8.6 Months.
All values presented are sourced from primary registry reporting; individual published papers should be consulted for comprehensive clinical decisions.
ctgov.study_references (PubMed PMIDs auto-attached by ClinicalTrials.gov to each trial), reference types RESULT, DERIVED, and BACKGROUND.ctgov.outcome_measurements joined to ctgov.design_outcomes where outcome_type = 'PRIMARY', restricted to phase PHASE3 and PHASE2/PHASE3.efetch.fcgi