Clinical Trials Logo

Clinical Trial Summary

There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer. The study is also looking at: - Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab - How REGN6569 and cemiplimab work in the body - How much REGN6569 and cemiplimab is in your blood - To see if REGN6569 can lower the number of Treg cells in tumors - To see if REGN6569 and cemiplimab can shrink tumors when given together


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Neoplasms
  • Squamous Cell Carcinoma of Head and Neck

NCT number NCT04465487
Study type Interventional
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Status Recruiting
Phase Phase 1
Start date October 5, 2020
Completion date June 22, 2026

See also
  Status Clinical Trial Phase
Completed NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Completed NCT02537223 - Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer Phase 1
Completed NCT00824343 - A Phase II Clinical Trial to Study the Efficacy and Safety of a New Drug P276-00 in Treatment of Recurrent and/or Locally Advanced Head and Neck Cancer Phase 2
Recruiting NCT06022757 - Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) Phase 1/Phase 2
Recruiting NCT05366166 - Pembrolizumab Plus Olaparib in LA-HNSCC Phase 2
Terminated NCT04502888 - Ph1 Study of SL-172154 Administered Intratumorally in Subjects With Squamous Cell Carcinoma of the Head and Neck or Skin Phase 1
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Completed NCT04098458 - Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC N/A
Not yet recruiting NCT04528420 - Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer N/A
Active, not recruiting NCT03997968 - A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05061420 - A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204) Phase 2
Completed NCT04939480 - Window of Opportunity Study of Preoperative Immunotherapy With Atezolizumab in Local SCCHN Phase 2
Recruiting NCT04260802 - A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers Phase 1/Phase 2
Not yet recruiting NCT05845307 - Randomized Pre-surgical Window-of-Opportunity Trial of TTI-101 in Patients With Stage II-IV Resectable HPV-negative Squamous Cell Carcinoma of the Head and Neck Early Phase 1
Active, not recruiting NCT04489888 - A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10) Phase 4
Recruiting NCT05544929 - A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers Phase 1
Completed NCT04601402 - GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy Phase 1
Completed NCT00756444 - A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 2
Withdrawn NCT04129320 - Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck Phase 2/Phase 3