Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trial
Official title:
A Ph 3, Prospective, Open-Label, Multicenter Study of Lymphoseek®-Identified Sentinel Lymph Nodes (SLNs) Relative to the Path Status of Non SLN in an Elective Neck Dissection in Cutaneous Head and Neck and Intraoral Squamous Cell Carcinoma
The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| 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| Withdrawn |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 | |
| Recruiting |
NCT06295731 -
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
|
Phase 2/Phase 3 | |
| Completed |
NCT04220866 -
Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)
|
Phase 2 | |
| 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 |