Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca
NCT04988074 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-03-03
Summary
To determine if it is feasible to use neoadjuvant immunotherapy (or immunotherapy plus chemotherapy) to reduce treatment intensity and improve long-term quality of life while maintaining very high cure rates.
Conditions
- HPV-Related Squamous Cell Carcinoma
Interventions
- DRUG
-
Cemiplimab for 9 weeks +/- Carboplatin + Paclitaxel
Sponsors & Collaborators
- collaborator INDUSTRY
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Nyall R London, M.D. · Johns Hopkins University/Sidney Kimmel Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-13
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery
NCT03565783 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
NCT04465487 ·Status: TERMINATED ·Phase: PHASE1
-
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
-
Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy
NCT04646005 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC
NCT06855212 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT04862650 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
NCT05376553 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1
-
A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
NCT07346196 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A PHASE II, RANDOMIZED TRIAL TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT VULVAR CANCER
NCT07101848 ·Status: NOT_YET_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
-
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
-
A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC
NCT04398524 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
NCT07195734 ·Status: RECRUITING ·Phase: PHASE2
-
Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer
NCT01693783 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix
NCT00006224 ·Status: TERMINATED ·Phase: PHASE2
-
Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer
NCT03107182 ·Status: COMPLETED ·Phase: PHASE2
-
Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer
NCT06997094 ·Status: RECRUITING ·Phase: PHASE1
-
Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer
NCT07062354 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma
NCT05535023 ·Status: WITHDRAWN ·Phase: PHASE2
-
Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma
NCT01554410 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for the Treatment of Cervical Cancer
NCT07266350 ·Status: NOT_YET_RECRUITING
-
Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer
NCT04906993 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
NCT02296684 ·Status: COMPLETED ·Phase: PHASE2
-
Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery
NCT01026792 ·Status: COMPLETED ·Phase: PHASE2