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Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Patients With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study (BiCaZO)
Jacksonville, Fla.
The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib plus nivolumab in each disease cohort, both across and within tumor biomarker subgroups.
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Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to evaluate the effectiveness and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1) vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care (SoC), best supportive care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma.
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A Phase 1 Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test the safety and side effects of a drug called SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body.
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A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab with Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants with High-risk Stage II-IV Melanoma (KEYVIBE-010) (KEYVIBE-010)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study to compare MK-7684A to pembrolizumab with respect to RFS, and to determine if MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator.
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Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Patients With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study (BiCaZO)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib plus nivolumab in each disease cohort, both across and within tumor biomarker subgroups.
Closed for Enrollment
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A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma
Rochester, Minn.
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with metastatic merkel cell carcinoma (MCC).
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ARRAY 818-201, A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis (POLARIS)
Rochester, Minn.
The purpose of this study is to assess the safety, effectiveness and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis.
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Immunotherapy and Ovarian Function Among Premenopausal Melanoma Survivors
Rochester, Minn.
The purpose of this study is to analyze the ovary function of female premenopausal melanoma survivors who have undergone immunotherapy, and to compare with data from age-matched controls.
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Phase I Study of Single Agent Pembrolizumab (MK-3475) in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma (KEYNOTE 001) (KEYNOTE-001)
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety, tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and compare every 2 week to every 3 week dosing. Part C of the study will explore the safety, tolerability, and efficacy of the drug in participants with non-small cell lung carcinoma (NSCLC) that is locally advanced or metastatic. Part D of the study will explore the low and high doses of study drug identified in Parts A and B in participants with advanced or metastatic MEL. Part E (closed with Amendment 7) will explore low, medium, and high doses of study drug in combination with standard chemotherapy in participants with locally advanced or metastatic NSCLC. Part F will explore low and high doses of study drug in treatment-naive and previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene expression. In Parts D and F and some of Part B participants will be randomized to one dose level. The primary hypotheses are the following: that pembrolizumab has acceptable safety and tolerability; and that pembrolizumab shows a clinically meaningful response rate (RR) or disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or not), and a clinically meaningful RR in participants with NSCLC, especially a clinically meaningful RR in those participants with either cancer, whose tumors express PD-L1.
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Pilot Study to Test the Safety and Efficacy of the Combination of Imiquimod and Pembrolizumab for the Treatment of Metastatic Melanoma
Jacksonville, Fla.
This pilot trial studies the side effects and how well imiquimod and pembrolizumab work in treating patients with stage IIIB-IV melanoma. Imiquimod may stimulate the immune system. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving imiquimod and pembrolizumab may work better at treating melanoma.
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