Clinical Trials Using Cemiplimab

Clinical trials are research studies that involve people. The clinical trials on this list are studying Cemiplimab. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-15 of 15
  • Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

    The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with REGN2810 in patients with advanced malignancies, including lymphoma. The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with REGN2810 (separately by cohort) as measured by objective response rate (ORR).
    Location: 17 locations

  • PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

    The primary objective is to estimate the overall response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with REGN2810 as a monotherapy
    Location: 17 locations

  • INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)

    Phase 1 / 2 trial to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with cemiplimab (REGN2810), with radiation and chemotherapy, in subjects with newly-diagnosed glioblastoma (GBM).
    Location: 14 locations

  • Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

    To estimate the clinical benefit of cemiplimab monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Groups 1 and 3) or with unresectable locally advanced CSCC (Group 2), or with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] treated (Group 4) as measured by overall response rate (ORR), according to central review.
    Location: 11 locations

  • A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and REGN2810 in Patients With Advanced Solid Tumors

    Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) - To determine the maximum tolerated dose (MTD) and / or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and REGN2810 combination therapy) - To determine the MTD and / or MAD of SAR439459 administered intravenously in combination with REGN2810 administered intravenously in adult patients with advanced solid tumors. Dose expansion (Part 2) Part 2A (SAR439459 monotherapy) - To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1. Part 2B (SAR439459 and REGN2810 combination therapy) - To determine the objective response rate (ORR) of SAR439459 in combination with REGN2810 in adult patients with selected advanced solid tumors by evaluation of antitumor response according to RECIST1.1. Secondary Objectives: - To characterize the pharmacokinetic (PK) profile of SAR439459 administered as monotherapy (Part 1A / 2A) and in combination with REGN2810 (Part 1B / 2B) and PK profile of REGN2810 in combination with SAR439459 (Part 1B / 2B). - To assess the immunogenicity of SAR439459 monotherapy (Part 1A / 2A) and SAR439459 and REGN2810 combination (Part 1B / 2B). Dose escalation (Part 1) - To characterize the overall safety and tolerability profile of SAR439459 administered as monotherapy and in combination with REGN2810. - To identify the preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or in combination with REGN2810. Dose expansion (Part 2) - To determine the progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP and safety in combination with REGN2810 in adult patients with selected advanced solid tumors. - To confirm the optimal dose of SAR439459 administered in combination with REGN2810.
    Location: 6 locations

  • Study of REGN2810 and REGN1979 in Patients With Lymphoma

    This is an open-label, multicenter, dose escalation study of REGN2810 and REGN1979 in patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on how an individual patient responds to treatment. The follow-up period will be 6 months for all patients.
    Location: 5 locations

  • Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Patients With Platinum-Resistant Ovarian Cancer

    The primary objectives of the Dose Escalation Phase are to assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab. In the Dose Expansion Phase, the primary objectives are to assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR). The secondary objectives of the Dose Escalation Phase are to assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR. In the Dose Expansion Phase, the secondary objectives are to characterize the safety profile in each expansion cohort and characterize the PK of REGN4018 as monotherapy and in combination with cemiplimab. In both the Dose Escalation and Dose Expansion Phases, secondary objectives are to assess preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as measured by ORR based on iRECIST, best overall response (BOR), duration of response (DOR), disease control rate, and progression-free survival (PFS) and to assess efficacy of REGN4018 as monotherapy and in combination with cemiplimab as measured by CA-125 level.
    Location: 6 locations

  • Study of REGN2810 in Adults With Cervical Cancer

    The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic platinum-refractory cervical cancer treated with either REGN2810 or investigator's choice (IC) chemotherapy. The secondary objectives are: - To compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy - To compare overall response rate (ORR) (partial response [PR] + complete response [CR]) of REGN2810 versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors 1.1 - To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy - To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse events (AE) - To compare quality of life (QOL) for patients treated with REGN2810 versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
    Location: 4 locations

  • REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma

    Phase 1: To confirm the safety and anticipated recommended phase 2 dose (RP2D) of the PD-1 inhibitor REGN2810 (cemiplimab) for children with recurrent or refractory solid or CNS tumors and to characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or Central Nervous System (CNS) tumors. Phase 2 (Efficacy Phase): - To confirm the safety and anticipated RP2D of REGN2810 to be given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) - To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed high-grade glioma (HGG) - To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with re-irradiation in patients with recurrent HGG - To assess PK of REGN2810 in pediatric patients with newly diagnosed DIPG, newly diagnosed HGG, or recurrent HGG when given in combination with radiation - To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at 12 months (OS12) among patients with newly diagnosed DIPG - To assess anti-tumor activity of REGN2810 in combination with radiation in improving progression-free survival at 12 months (PFS12) among patients with newly diagnosed HGG - To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at OS12 among patients with recurrent HGG
    Location: 7 locations

  • Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

    Primary Objectives: - To characterize the safety and tolerability of isatuximab in combination with REGN2810 in patients with metastatic, castration-resistant prostate cancer (mCRPC) who are naïve to anti-programmed cell death-1 (PD-1) / programmed cell death-ligand 1 (PD-L1)-containing therapy, or non-small cell lung cancer (NSCLC) who progressed on anti-PD-1 / PD-L1-containing therapy, and to confirm the recommended Phase 2 dose (RP2D). - To assess the response rate of isatuximab in combination with REGN2810 in patients with either mCRPC who are anti-PD-1 / PD-L1 therapy naive, or NSCLC who progressed on anti-PD-1 / PD-L1 therapy, or of isatuximab as single agent in patients with mCRPC. Secondary Objectives: - To evaluate the safety of the combination of isatuximab with REGN2810 or isatuximab monotherapy. - To evaluate the immunogenicity of isatuximab and REGN2810. - To characterize the pharmacokinetic (PK) profile of isatuximab single agent or in combination with REGN2810, and to characterize the PK of REGN2810 in combination with isatuximab. - To assess overall efficacy of isatuximab in combination with REGN2810 or as a single agent.
    Location: 3 locations

  • A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC

    This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.
    Location: 3 locations

  • A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

    The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810 / ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.
    Location: 2 locations

  • Isatuximab in Combination With Cemiplimab in Relapsed / Refractory Multiple Myeloma (RRMM) Patients

    Primary Objectives: - To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse / refractory multiple myeloma. - To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria. Secondary Objectives: - To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS). - To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination. - To assess the immunogenicity of isatuximab and cemiplimab when given in combination.
    Location: 3 locations

  • Cemiplimab in Treating Participants with Recurrent Stage III-IV Head and Neck Squamous Cell Cancer before Surgery

    This phase II trial studies how well cemiplimab works before surgery in treating participants with stage III-IV head and neck squamous cell cancer that has come back. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Stereotactic Body Radiation Therapy with REGN2810 and / or Ipilimumab before Surgery in Treating Participants with Progressive Advanced or Oligometastatic Prostate Cancer

    This phase I trial studies the side effects of anti-PD-1 monoclonal antibody REGN2810 (REGN2810) and / or ipilimumab when given together with stereotactic body radiation therapy before surgery in treating participants with prostate cancer that is growing, spreading, or getting worse, and has spread to other places in the body, or formed a small number of new tumors in one or two other parts of the body. Monoclonal antibodies, such as anti-PD-1 monoclonal antibody REGN2810 and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving anti-PD-1 monoclonal antibody REGN2810 and ipilimumab with stereotactic body radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania