Clinical trials: Cemiplimab
Advanced Cancer, Advanced Malignancies
Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies
This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.
- Trial name
- NCT02383212
- Testing
- Cemiplimab, Hypofractionated radiotherapy, Cyclophosphamide
- Where
- 47 sites in United States, Australia and 1 more
- Volunteers
- 398 people
- Sponsor
- Regeneron Pharmaceuticals
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer
This phase II trial tests how well cemiplimab and transarterial radioembolization (TARE) with yttrium-90 (Y90) SIR-Spheres, registered trademark, works in treating breast cancer that has spread from where it first started…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Carcinoma in the Liver
- Trial name
- NCT06860815
- Testing
- Biopsy, Biospecimen Collection, Cemiplimab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- City of Hope Medical Center
NSCLC Stage IV, Sex Disorder
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research.
- Conditions
- NSCLC Stage IV, Sex Disorder, Hypogonadism, Male, Erectile Dysfunction
- Trial name
- EROS (NCT06532149)
- Testing
- Alectinib, Brigatinib, Lorlatinib 100 mg
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Brain Tumor, Non Small Cell Lung Cancer
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA…
- Trial name
- LIMITLESS (NCT05317858)
- Testing
- Blood Brain Barrier Opening - Oncology, Pembrolizumab, Atezolizumab
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 96 people
- Sponsor
- InSightec
Advanced Non-small Cell Lung Cancer
Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Participants
This multi-year cohort study will assess the real-world safety and effectiveness of first Line (1L) treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC participant subgroups defined…
- Trial name
- NCT06269133
- Testing
- REGN2810, Platinum-doublet chemotherapy
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Regeneron Pharmaceuticals
Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC)
A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)").
- Conditions
- Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC), Advanced Solid Tumors
- Trial name
- BrILliance (NCT06413680)
- Testing
- REGN10597, Cemiplimab
- Where
- 11 sites in United States
- Volunteers
- 240 people
- Sponsor
- Regeneron Pharmaceuticals
Non-Small Cell Lung Cancer
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with…
- Trial name
- LuCa-MERIT-1 (NCT05142189)
- Testing
- BNT116, Cemiplimab, Docetaxel
- Where
- 45 sites in United States, Australia and 6 more
- Volunteers
- 320 people
- Sponsor
- BioNTech SE
Non-Small Cell Lung Cancer
A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
ARCH is a randomised, stratified, multicentre, phase III trial. Protocol treatment consists of cemiplimab, 350 mg i.v., every 3 weeks, for 4 cycles, followed by 700 mg i.v., every 6 weeks for 6 cycles or until relapse or…
- Trial name
- ARCH (NCT06931717)
- Testing
- Cemiplimab
- Where
- 35 sites in Austria, Estonia and 7 more
- Volunteers
- 390 people
- Sponsor
- ETOP IBCSG Partners Foundation
NSCLC Stage IV
Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
This is a multi-center, double-blind, placebo-controlled randomized phase II study to assess whether continuation of cemiplimab treatment (for up to 12 months) increases progression-free survival (PFS) as compared to placebo in…
- Trial name
- ICARS (NCT06219317)
- Testing
- Cemiplimab
- Where
- 12 sites in Belgium, France and 3 more
- Volunteers
- 136 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Solid Cancer
Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1
This is an open labeled, non-randomized adaptive pilot study. The study interventions involved in this study are: Poly-ICLC (Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose, also known as…
- Trial name
- NCT03721679
- Testing
- Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Oncovir, Inc.
Recurrent Squamous Cell Carcinoma of Head, Recurrent Squamous Cell Carcinoma of Neck
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.
- Conditions
- Recurrent Squamous Cell Carcinoma of Head, Recurrent Squamous Cell Carcinoma of Neck, Metastatic Squamous Cell Carcinoma of Head, Metastatic Squamous Cell Carcinoma Neck
- Trial name
- NCT03198130
- Testing
- REGN2810
- Where
- 6 sites in South Korea, United Kingdom
- Volunteers
- 33 people
- Sponsor
- Regeneron Pharmaceuticals
Squamous Cell Carcinoma (SCC), Recurrent or Metastatic, Platinum-refractory Cervical Cancer
Study of Cemiplimab in Adults With Cervical Cancer
The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either…
- Trial name
- NCT03257267
- Testing
- Cemiplimab, Investigator Choice (IC) Chemotherapy
- Where
- 105 sites in United States, Australia and 12 more
- Volunteers
- 608 people
- Sponsor
- Regeneron Pharmaceuticals
Colorectal Cancer
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients…
- Trial name
- NCT06205836
- Testing
- Cemiplimab, Fianlimab
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Advanced Squamous Non-Small Cell Lung Cancer
A Multicenter Open-label Phase II Study of Cemiplimab Plus Chemotherapy, Selected on the Basis of Baseline Cytidine Deaminase Activity, in Advanced Squamous Non-small Cell Lung Cancer
This is a multicenter phase II study enrolling treatment- naïve patients with metastatic or recurrent squamous carcinoma of the lung
- Trial name
- CECYDE (NCT07418931)
- Testing
- Cemiplimab 350 mg IV, Paclitaxel 200 mg/sqm IV, Carboplatin AUC 5 IVa
- Where
- 15 sites in Italy
- Volunteers
- 108 people
- Sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
Cutaneous Squamous Cell Carcinoma
Expanded Access Protocol for Cemiplimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
The objective of this program is to provide access to cemiplimab (REGN2810) to patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not…
- Trial name
- NCT03492489
- Testing
- cemiplimab
- Sponsor
- Regeneron Pharmaceuticals
Cutaneous Squamous Cell Carcinoma (CSCC), Advanced Cutaneous Squamous Cell Carcinoma
D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab
D-TECT is a prospective, multicenter, non-interventional observational study investigating whether pretreatment D-dimer levels predict disease control in patients with locally advanced or metastatic cutaneous squamous cell…
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC), Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma
- Trial name
- D-TECT (NCT07684066)
- Testing
- Pretreatment D-dimer status
- Where
- 15 sites in Austria, Germany
- Volunteers
- 116 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Melanoma BRAF V600E/K Mutated, Melanoma and Brain Metastases
Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases
Brain metastases in patients with advanced and metastatic melanoma are a frequent complication and a significant cause of morbidity and mortality in this patient population.
- Trial name
- ENCEFALO (NCT06887088)
- Testing
- Encorafenib + Binimetinib, cemiplimab+fianlimab
- Where
- 18 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Grupo Español Multidisciplinar de Melanoma
Head and Neck Squamous Cell Carcinoma (HNSCC)
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
This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not…
- Trial name
- NCT06769698
- Testing
- FDC fianlimab+cemiplimab, Cemiplimab
- Where
- 38 sites in United States, Australia and 4 more
- Volunteers
- 120 people
- Sponsor
- Regeneron Pharmaceuticals
Advanced Renal Cell Carcinoma (aRCC), Metastatic Renal Cell Carcinoma ( mRCC)
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or…
- Conditions
- Advanced Renal Cell Carcinoma (aRCC), Metastatic Renal Cell Carcinoma ( mRCC), Clear Cell Renal Cell Carcinoma (ccRCC)
- Trial name
- NCT07188896
- Testing
- Fianlimab, Ipilimumab, Nivolumab
- Where
- 5 sites in United States
- Volunteers
- 120 people
- Sponsor
- Brian Rini
Basal Cell Carcinoma (BCC), First Line Treatment
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
The study is an open-label, singel arm, prospective, multicenter phase II trial evaluating the efficacy and safety of Cemiplimab when applied as first-line therapy in patients with locally advanced basal cell carcinoma (BCC)…
- Trial name
- CEMI-first (NCT06981325)
- Testing
- Cemiplimab
- Where
- 7 sites in Germany
- Volunteers
- 34 people
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest