Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone: 1. In participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and 2. In participants with a tumor that has a PD-L1 CPS ≥ 20.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04220866
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase Phase 2
Start date March 4, 2020
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Withdrawn NCT02211027 - Biological Vaccine: Semi-allogeneic Human Fibroblasts (MRC-5) Transfected With DNA Phase 1
Recruiting NCT04083599 - GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors Phase 1/Phase 2
Completed NCT03735628 - An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05891171 - Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers Phase 1
Recruiting NCT03546582 - SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma Phase 2
Not yet recruiting NCT06102447 - Efficacy and Safety of Netupitant and Palonosetron Hydrochloride Capsules in Preventing Nausea and Vomiting Induced by Radiochemotherapy in Head and Neck Squamous Cell Carcinoma N/A
Terminated NCT00911326 - Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma Phase 3
Recruiting NCT06295731 - INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC Phase 2/Phase 3
Withdrawn NCT03114280 - Pembrolizumab and Induction Chemotherapy in Head and Neck Squamous Cell Carcinoma (PICH Study) Phase 1/Phase 2
Completed NCT02764593 - Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer Phase 1
Withdrawn NCT04849377 - RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC Phase 2
Completed NCT03268993 - Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer N/A
Recruiting NCT04284540 - Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma N/A
Recruiting NCT04080804 - Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer Phase 2
Active, not recruiting NCT04215978 - Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT03746431 - A Phase 1/2 Study of [225Ac]-FPI-1434 Injection Phase 1/Phase 2
Active, not recruiting NCT05249426 - A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer Phase 1
Not yet recruiting NCT05473156 - A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies Phase 1/Phase 2
Completed NCT02684253 - Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Phase 2
Terminated NCT03276819 - A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With OPML or HNSCC N/A