Clinical Trials Using Pembrolizumab

Clinical trials are research studies that involve people. The clinical trials on this list are studying Pembrolizumab. 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 101-125 of 500
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  • Pembrolizumab as First-Line Therapy in Treating Participants with High-Risk Non-Muscle-Invasive Bladder Cancer

    This phase II trial studies how well pembrolizumab works as first-line therapy in treating participants with high-risk non-muscle-invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 7 locations

  • Talimogene Laherparepvec and Pembrolizumab in Treating Patients with Locally Advanced or Metastatic Sarcoma

    This phase II trial studies how well talimogene laherparepvec and pembrolizumab work in treating patients with sarcoma that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Talimogene laherparepvec may cause tumor cell death directly in the area of tumor that it is injected into and help the immune system to recognize and destroy tumor cells present at other sites in the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talimogene laherparepvec and pembrolizumab may work better in treating patients with sarcoma.
    Location: 7 locations

  • Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365 / KEYNOTE-365)

    The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be nine cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive vibostolimab (+) pembrolizumab coformulation (MK-7684A), Cohort H will receive vibostolimab (+) pembrolizumab coformulation, and Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2. Outcome measures will be assessed individually for each cohort.
    Location: 7 locations

  • Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients with Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

    This phase II trial studies how well pembrolizumab works when given together with endocrine therapy and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Estrogen can cause the growth of breast cancer cells. Antihormone therapy, such as letrozole and fulvestrant, may lessen the amount of estrogen made by the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, palbociclib, and letrozole or fulvestrant may be an effective treatment for patients with stage IV estrogen receptor positive breast cancer.
    Location: 7 locations

  • CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab in Subjects With Advanced GI Tumors (Keynote 596)

    This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a CGX1321 Single Agent Dose Escalation Phase in solid tumors, CGX1321 Single Agent Dose Expansion Phase in GI tumors and Roll-over Cohort of CGX1321 and pembrolizumab in subjects who have progressed on single agent CGX1321 and Phase 1b consisting of CGX1321 in combination with pembrolizumab in colorectal tumors. Both phases are to evaluate safety, pharmacokinetics, and clinical activity.
    Location: 7 locations

  • Mesothelin-Specific Genetically Engineered Lymphocytes with or without Cyclophosphamide and Pembrolizumab in Treating Patients with Malignant Pleural Disease

    This phase I / II trial studies the side effects and best dose of mesothelin-specific chimeric antigen receptor-engineered peripheral blood lymphocytes and to see how well it works with or without cyclophosphamide and pembrolizumab in treating patients with a malignant disease found in the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity (pleura), including malignant pleural mesothelioma, or previously treated non-small cell lung cancer or breast cancer that has spread to the pleura. Placing a gene that has been created in the laboratory into white blood cells (lymphocytes) may help the body build an immune response to kill tumor cells expressing the protein mesothelin. Drugs used in chemotherapy, such as cyclophosphamide, 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving mesothelin-specific chimeric antigen receptor-engineered peripheral blood lymphocytes with or without cyclophosphamide may be a better treatment for malignant pleural disease.
    Location: 7 locations

  • Pembrolizumab and Ziv-aflibercept in Treating Patients with Advanced Solid Tumors

    This phase I trial studies the side effects and best dose of ziv-aflibercept when given together with pembrolizumab in treating patients with solid tumors that have spread to other places in the body (advanced). Ziv-afibercept works by decreasing blood and nutrient supply to the tumor, which may result in shrinking the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ziv-aflibercept together with pembrolizumab may be a better treatment for patients with advanced solid tumors.
    Location: 7 locations

  • Testing the Addition of Pembrolizumab to Sacituzumab Govitecan for the Treatment of PD-L1 Negative Locally Advanced Unresectable or Metastatic Triple Negative Breast Cancer, Saci-IO TNBC Study

    This phase II trial investigates how well the addition of pembrolizumab to sacituzumab govitecan works in treating patients with PD-L1 negative triple negative breast cancer that has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable) or to other places in the body (metastatic). Sacituzumab govitecan is composed of a chemotherapy drug, called irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don't belong in the body to prevent harm. Sacituzumab govitecan binds to the cancer cells and kills them. Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is an antibody (a type of human protein) designed to allow the body’s own immune system to seek out and destroy tumors. This trial is being done to evaluate the effectiveness of sacituzumab govitecan alone or in combination with pembrolizumab, in delaying the worsening of triple negative breast cancers that are PD-L1 negative.
    Location: 6 locations

  • Study of PDS0101 and Pembrolizumab Combination I / O in Subjects With HPV16 + Recurrent and / or Metastatic HNSCC

    VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
    Location: 8 locations

  • AcceleRET Lung Study of Pralsetinib for 1L RET Fusion-positive, Metastatic NSCLC

    This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcome when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for patients with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Patients who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.
    Location: 6 locations

  • KEYMAKER-U01 Substudy 1: Efficacy and Safety Study of Pembrolizumab (MK-3475) Plus Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A / KEYMAKER-U01A)

    The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) PLUS chemotherapy in combination with vibostolimab (MK-7684) or MK-5890 in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01 / KEYMAKER-U01).
    Location: 6 locations

  • A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation

    The primary objective is to assess the activity and efficacy of pembrolizumab, a checkpoint inhibitor, in Veterans with metastatic castration-resistant prostate cancer (mCRPC) characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12 (CDK12- / -). The secondary objectives involve determining the frequency with which dMMR and CDK12- / - occur in this patient population, as well as the effects of pembrolizumab on various clinical endpoints (time to PSA progression, maximal PSA response, time to initiation of alternative anti-neoplastic therapy, time to radiographic progression, overall survival, and safety and tolerability). Lastly, the study will compare the pre-treatment and at-progression metastatic tumor biopsies to investigate the molecular correlates of resistance and sensitivity to pembrolizumab via RNA-sequencing, exome-sequencing, selected protein analyses, and multiplexed immunofluorescence.
    Location: 6 locations

  • An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients

    This study evaluates the combination of bavituximab and pembrolizumab in the treatment of gastric and gastroesphogeal cancer. All patients will receive both bavituximab, a drug that is not yet approved by the FDA, and pembrolizumab known as Keytruda. There is no expanded access program available for the investigational agents per this protocol.
    Location: 6 locations

  • GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma

    This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid Tumors
    Location: 7 locations

  • Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080 / MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008 / E7080-G000-316 / LEAP-008)

    This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080 / MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1 / PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).
    Location: 6 locations

  • A Study of mRNA-5671 / V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

    This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671 / V941) as a monotherapy and in combination with pembrolizumab infusion.
    Location: 6 locations

  • Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (MK-3475-905 / KEYNOTE-905 / EV-303)

    A global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).
    Location: 9 locations

  • A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)

    This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
    Location: 7 locations

  • Pembrolizumab, Carboplatin and Docetaxel in Treating Patients with Stage I-III Triple-Negative Breast Cancer before Surgery

    This phase II trial studies how well pembrolizumab, carboplatin and docetaxel work in treating patients with stage I-III triple-negative breast cancer before surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 carboplatin and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab, carboplatin and docetaxel before surgery may work better in treating stage I-III triple-negative breast cancer.
    Location: 6 locations

  • A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors

    Part 1 is the dose escalation of APG-115 in combination with label dose of pembrolizumab. Part 2 is phase II design of APG-115 at recommended phase 2 dose (RP2D) in combination with pembrolizumab in the patients with programmed cell death protein 1 (PD-1) / programmed death-ligand 1 (PD-L1) refractory / relapse melanoma or NSCLC, solid tumors with P53 WT and ATM mutation, P53 WT and MDM2 amplification liposarcomas, PD-1 / PD-L1 refractory / relapsed urothelial carcinoma without FGFR translocation mutation, and MPNST.
    Location: 6 locations

  • SBRT + / - Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

    This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).
    Location: 7 locations

  • A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

    The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
    Location: 6 locations

  • Radiation Therapy and Pembrolizumab or Cisplatin in Treating Patients with Stage III / IV p16 Positive Head and Neck Squamous Cell Carcinoma

    This phase II trial studies how well radiation therapy works when given with pembrolizumab or cisplatin in treating patients with stages III / IV p16-positive head and neck squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 cisplatin, 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. It is not yet known whether giving pembrolizumab during and after radiation therapy or cisplatin during radiation therapy works better in treating participants with head and neck squamous cell carcinoma.
    Location: 6 locations

  • Pembrolizumab, Carboplatin, and Pemetrexed in Treating Patients with EGFR Mutant and ALK Positive Non-small Cell Lung Cancer

    This phase II trial studies how well pembrolizumab works in combination with carboplatin and pemetrexed in treating patients with EGFR mutant and ALK positive non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 carboplatin, 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. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, carboplatin, and pemetrexed may work better at treating non-small cell lung cancer.
    Location: 6 locations

  • Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors

    This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization will include first-line and second-line melanoma, non-small cell lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), and hepatocellular carcinoma (HCC) regardless of PD-L1 expression status. This cohort will include patients enrolled in a 3 + 3 dose escalation and intra-patient step-up dose schemas. The dose expansion cohort will include first-line NSCLC patients regardless of PD-L1 expression status.
    Location: 8 locations


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