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 1-19 of 19
  • 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 cemiplimab 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 cemiplimab (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: 15 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: 9 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: 6 locations

  • A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab 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 cemiplimab combination therapy) - To determine the MTD and / or MAD of SAR439459 administered intravenously in combination with cemiplimab 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 cemiplimab combination therapy) - To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). Secondary Objectives: - Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459. - Immunogenicity of SAR439459 monotherapy and combined with cemiplimab. Dose escalation (Part 1) - Overall safety / tolerability profile of SAR439459 monotherapy and combined with cemiplimab. - Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab. Dose expansion (Part 2) - Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP and safety in combination with cemiplimab in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 or anti-PD-L1 and patients with mesenchymal Colorectal cancer. - PFS, duration of response (DOR) and safety in adult patients with metastatic urothelial cancer. - To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.
    Location: 6 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: 8 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: 8 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

  • Study of REGN2810 in Adults With Cervical Cancer

    The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer treated with either REGN2810 (cemiplimab) or investigator's choice (IC) chemotherapy. The secondary objectives are: - To compare progression-free survival (PFS) of REGN2810 (cemiplimab) versus IC chemotherapy - To compare overall response rate (ORR) (partial response [PR] + complete response [CR]) of REGN2810 (cemiplimab) versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - To compare the duration of response (DOR) of REGN2810 (cemiplimab) versus IC chemotherapy - To compare the safety profiles of REGN2810 (cemiplimab) versus IC chemotherapy by describing adverse events (AE) - To compare quality of life (QOL) for patients treated with REGN2810 (cemiplimab) versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
    Location: 3 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: 4 locations

  • Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma

    The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with recurrent CSCC. The secondary objectives of this study are: - To describe the objective response rate (ORR) in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC, according to modified World Health Organization (WHO) criteria - To describe the pathologic complete response (CR) rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC - To describe the major pathologic response rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC - To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with recurrent CSCC - To assess the immunogenicity of cemiplimab in patients with recurrent CSCC - To establish a recommended dose of intralesional cemiplimab for further study in patients with recurrent CSCC
    Location: 2 locations

  • Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma

    This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. Cemiplimab-rwlc (Libtayo) is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Libtayo (cemiplimab-rwlc) is currently FDA approved in the United States for metastatic cutaneous cell carcinoma (CSCC), but is not approved in glioblastoma. Cemiplimab-rwlc may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with cemiplimab-rwlc to enhance the IL-12 mediated effect observed to date. The main purpose of this study is to evaluate the safety and efficacy of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with cemiplimab-rwlc.
    Location: Northwestern University, Chicago, Illinois

  • Study of REGN5678 (Anti-PSMAxCD28) With Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer

    The primary objectives of the study in Dose Escalation are to evaluate safety, tolerability, and pharmacokinetics (PK) of REGN5678 alone and in combination with cemiplimab and in Dose Expansion are to assess efficacy, as measured by objective response rate (ORR) per modified Prostate Cancer Working Group 3 (PCWG3) criteria, of REGN5678 in combination with cemiplimab. The secondary objectives of the study in Dose Escalation are to assess efficacy, as measured by ORR per modified PCWG3 criteria, of REGN5678 in combination with cemiplimab and in Dose Expansion are to characterize the safety profile in each expansion cohort and to characterize the PK of REGN5678 in combination with cemiplimab. Secondary objectives in both Dose Escalation and Dose Expansion are to assess efficacy of REGN5678 in combination with cemiplimab, as measured by additional criteria and to assess immunogenicity of REGN5678 in combination with cemiplimab.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • Androgen Deprivation Therapy (Leuprolide and Degarelix) and Chemoimmunotherapy (Cemiplimab and Docetaxel) for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer

    This phase II trial studies the side effects of androgen deprivation therapy (leuprolide and degarelix) and chemoimmunotherapy (cemiplimab and docetaxel) and to see how well they work in treating patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic). Androgen can cause the growth of prostate cancer cells. Hormone therapy using leuprolide and degarelix may fight prostate cancer by blocking the use of androgen by the tumor cells. 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. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this study is to determine if the addition of immunotherapy to chemotherapy and androgen deprivation therapy, is safe and improves response to therapy.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC

    The primary objective of the study is to evaluate the clinical activity of neoadjuvant cemiplimab therapy in patients with resectable Non-small cell lung cancer (NSCLC), Hepatocellular carcinoma (HCC), and Head and neck squamous cell carcinoma (HNSCC) lesions, as measured by pathological evaluations of resected tumors. The secondary objectives of the study are: - To assess the anti-tumor activity of neoadjuvant and adjuvant cemiplimab therapy as defined by multiple criteria - To determine the safety and tolerability of neoadjuvant and adjuvant cemiplimab therapy including delay to surgery - To assess the change in tumor-infiltrating CD8 T-cell density and to explore the correlation to the pathological response to therapy
    Location: Icahn School of Medicine at Mount Sinai, New York, New York

  • Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

    The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.
    Location: University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma

  • Cemiplimab in Treating Patients with Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer before Surgery

    This phase II trial studies how well cemiplimab works before surgery in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent) and can be removed by surgery (resectable). 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

  • A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

    Primary Objectives: - Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options. - Dose expansion (Monotherapy): To determine the objective response rate of SAR441000 administered intratumorally as monotherapy in patients with advanced melanoma whose disease has progressed after prior therapy based on anti-PD-1 or anti-PD-L1. - Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma. Secondary Objectives: - To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab. - To assess the immunogenicity of SAR441000. - To characterize the safety of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab. - To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000. - To determine the recommended dose of SAR441000 for the expansion phase.
    Location: M D Anderson Cancer Center, Houston, Texas