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 1-25 of 25
  • 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: 19 locations

  • I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

    The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
    Location: 18 locations

  • Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

    The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: - To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT - To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT
    Location: 13 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 REGN2810 (cemiplimab) for children with recurrent or refractory solid or Central Nervous System (CNS) tumors - To characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or 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: 12 locations

  • Intratumoral AST-008 Combined With Pembrolizumab or Cemiplimab in Patients With Advanced Solid Tumors

    This is a phase 1b / 2, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral AST-008 injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with advanced solid tumors. Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of AST-008 given with a fixed dose of pembrolizumab. The Phase 2 dose expansion part of the study will consist of two cohorts of patients: Merkel cell carcinoma (MCC) and cutaneous squamous cell carcinoma (CSCC). Patients in the MCC cohort will receive IT AST-008 combined with a fixed, standard dose of pembrolizumab while the CSCC cohort will receive IT AST-008 combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI or are otherwise refractory to CPI therapy.
    Location: 10 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, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab. - To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.
    Location: 8 locations

  • Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Patients With Recurrent 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) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 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 by RECIST 1.1. 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 immune based therapy RECIST (iRECIST), best overall response (BOR), duration of response (DOR), disease control rate, and progression-free survival (PFS) based on RECIST 1.1 and iRECIST, to assess efficacy of REGN4018 as monotherapy and in combination with cemiplimab as measured by CA-125 level and immunogenicity of REGN4018 and cemiplimab.
    Location: 8 locations

  • Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

    The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review. The secondary objectives of the study are: - To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including: - Major pathologic response (mPR) rate per independent central pathology review - pCR rate and mPR rate per local pathology review - ORR prior to surgery, according to local assessment using RECIST 1.1 - To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS) - To evaluate the safety profile of neoadjuvant cemiplimab - To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review - To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review
    Location: 6 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

  • Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

    To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) according to central review.
    Location: 9 locations

  • Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients

    This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will concurrently enroll patients with four distinct advanced malignancies in 5 separate tumor cohorts. The four cancers type are NSCLC and melanoma that are progressing on CPI treatment, CPI-naïve HCC, and treatment-naïve Endometrial.
    Location: 6 locations

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

    For Groups 1 to 4, the primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC. For Group 6, the primary objective is to provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced. Clinical benefit is measured by overall response rate (ORR) according to central review in each group.
    Location: 6 locations

  • 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: 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: 3 locations

  • 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: 3 locations

  • Cemiplimab for the Treatment of Immunocompromised Patients with Unresectable Locally Recurrent and / or Metastatic Cutaneous Squamous Cell Carcinoma

    This phase II trial studies how well cemiplimab works for the treatment of patients that have a weakened immune system (immunocompromised) and squamous cell carcinoma affecting the skin (cutaneous) that cannot be removed by surgery (unresectable), has come back at or near the same place as the original tumor (locally recurrent) and / or has spread to other places in the body (metastatic). 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: 6 locations

  • Study of Cemiplimab Combined with Dabrafenib and Trametinib in People with Anaplastic Thyroid Cancer

    This phase II studies how well dabrafenib, trametinib, and cemiplimab work for the treatment of patients with anaplastic thyroid cancer that is BRAF-mutated, and is no longer responding to dabrafenib and trametinib. This study will also look at the safety of this combination treatment. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving cemiplimab in combination with dabrafenib and trametinib may work better than dabrafenib and trametinib alone in treating patients with BRAF-mutated anaplastic thyroid cancer.
    Location: Memorial Sloan Kettering 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

  • 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 Study of Recombinant Vaccinia Virus in Combination With REGN2810 for Renal Cell Carcinoma

    This is a Phase 1b, open-label, multi-center, dose-escalation trial of Pexa-Vec plus REGN2810 in patients with metastatic or unresectable renal cell carcinoma (RCC). The trial consists of a dose-escalation stage, where the maximum feasible dose of Pexa-Vec in combination with REGN2810 will be determined, followed by an expansion stage. During the expansion patients will receive REGN2810 alone or in combination with Pexa-Vec, which will be administered either through intravenous (IV) or intratumoral (IT) injection.
    Location: University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida

  • Short-term Fasting prior to Standard of Care PD-1 / PD-L1 Inhibitor Therapy for the Treatment of Advanced or Metastatic Skin Malignancy

    This phase I trial studies the side effects of short-term fasting in patients with skin malignancy that has spread to other places in the body (advanced or metastatic) treated with a PD-L1 or PD-1 inhibitor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab, cemiplimab, avelumab, atezolizumab, or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Undergoing short-term fasting prior to treatment with one of these PD-L1 or PD-1 inhibitors may potentially reduce the side effects of immunotherapy or even improve the effectiveness of immunotherapy in patients with skin malignancy.
    Location: 2 locations

  • A PD-1 Checkpoint Inhibitor (Cemiplimab) before Surgery for the Treatment of High-Risk Localized, Locally Recurrent, or Regionally Advanced Resectable Skin Cancer

    This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), 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: 3 locations

  • Cemiplimab before and after Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer

    This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. 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. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia