Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT04831450 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-08-04
Summary
The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.
Conditions
- Head and Neck Squamous Cell Carcinoma
- HNSCC
- Squamous Cell Carcinoma of the Larynx
- Squamous Cell Carcinoma of the Oral Cavity
- Squamous Cell Carcinoma of Hypopharynx
Interventions
- DRUG
-
Cemiplimab-Rwlc
350 mg Cemiplimab administered via intravenous infusion over 30 minutes on Day 1 of a 21-day cycle.
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Miami
lead OTHER
Principal Investigators
-
Chukwuemeka Ikpeazu, MD · University of Miami
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-31
- Primary Completion
- 2022-07-15
- Completion
- 2022-07-15
- FDA Drug
- Yes
More Related Trials
-
Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC
NCT06855212 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT06769698 ·Status: RECRUITING ·Phase: PHASE2
-
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
NCT06980038 ·Status: RECRUITING ·Phase: PHASE2
-
Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma
NCT03422536 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer
NCT03468218 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer
NCT07062354 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer
NCT05296135 ·Status: WITHDRAWN
-
INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT05359692 ·Status: WITHDRAWN ·Phase: PHASE2
-
Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma
NCT07281417 ·Status: RECRUITING ·Phase: PHASE2
-
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
NCT01256385 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
NCT07346196 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
NCT04858269 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT04633278 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Cemiplimab in Adults With Cervical Cancer
NCT03257267 ·Status: COMPLETED ·Phase: PHASE3
-
Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
NCT02296684 ·Status: COMPLETED ·Phase: PHASE2
-
Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN
NCT05743270 ·Status: WITHDRAWN ·Phase: PHASE2
-
TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
NCT06868433 ·Status: RECRUITING ·Phase: PHASE1
-
Immune Modulation by Abemaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC). (AIM Trial)
NCT04169074 ·Status: TERMINATED ·Phase: PHASE2
-
Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer
NCT04458909 ·Status: TERMINATED ·Phase: PHASE3
-
Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT04128696 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
NCT06385080 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
NCT05172258 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
NCT04058145 ·Status: WITHDRAWN ·Phase: PHASE2
-
Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
NCT00513435 ·Status: COMPLETED ·Phase: PHASE2
-
Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy
NCT04326257 ·Status: COMPLETED ·Phase: PHASE2