Clinical trial · Interventional
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer
A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer
NCT03937141CI-TRIAL-00055737terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No substantial anti-tumor activity was observed.
Summary
Brief summary (as posted)
ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADU-S100 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADU-S100 and pembrolizumab
- description
- All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
- interventionNames
- Drug: ADU-S100
Primary outcomes (1)
- measure
- Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- timeFrame
- Up to 25 months
- description
- To determine ORR of ADU-S100 in combination with pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell cancer (HNSCC). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmation of recurrent or metastatic HNSCC * Measurable disease as defined by RECIST v1.1 * PD-L1 positive Exclusion Criteria: * Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary histology; or salivary gland or non-squamous histologies (e.g. mucosal melanoma) * Disease amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) * Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or metastatic HNSCC
References
Publications (1)
- DERIVEDGogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453. PMID 32823563