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A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab (PAVE-1)
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as well as preliminary clinical effects. The Dose Confirmation Phase will consist of two additional cohorts in patients with non-small cell lung cancer or urothelial carcinoma who will be treated at or below the MTD of PT-112 in the combination.
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Cemiplimab Survivorship Epidemiology (CASE) Study (CASE)
Jacksonville, Fla.
The primary purpose of this study is to identify potential determinants of disease progression, Quality of Life (QOL), and other health-related outcomes for patients with Cutaneous squamous cell carcinoma (CSCC) undergoing treatment with cemiplimab. In addition, the study will aim to assess patient experience, including QOL and functional status, to identify and describe long-term effects of treatment of patients with CSCC, to collect and describe serious adverse event (SAE) and immune-related adverse event (irAE) data on study participants, to describe patients who receive cemiplimab as treatment for CSCC in a real-world setting, to describe real-world use patterns of cemiplimab for CSCC, to assess the long-term effectiveness of cemiplimab in CSCC patients in a real-world setting, to assess the effectiveness of cemiplimab as a first-line or later systemic treatment in patients with Advanced and metastatic cutaneous squamous cell carcinoma (aCSCC), regardless of etiology, to assess the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with a CSCC, regardless of etiology, to assess the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC.
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MC1376 Phase I Trial to Evaluate the Safety and Efficacy of Intratumoral and Intravenous Injection of Vesicular Stomatitis Virus Expressing Human Interferon Beta, and Tyrosinase Related Protein 1 (VSV-IFNb-TYRP1) in Patients with Metastatic Ocular Melanoma and Previously Treated Patients with Unresectable Stage III/IV Cutaneous Melanoma
Rochester, Minn.
The purpose of this study is to determine the safety profile and maximum tolerated dose (MTD) of VSV-IFNß-TYRP1 therapy when administered by IV and IT injection in patients with previously treated metastatic melanoma.
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MC1776 Neoadjuvant Therapy for Patients With High Risk Stage III Melanoma: A Pilot Clinical Trial (NeoACTIVATE)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this early phase I pilot trial studies how well vemurafenib, cobimetinib, and atezolizumab work in treating participants with high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib, cobimetinib, and atezolizumab may work better in treating high-risk stage III melanoma.
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MMP1602: Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252
Rochester, Minn.
The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.
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PT-112-101, A Phase I, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects with Advanced Solid Tumors
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the maximum tolerated dose, and evaluate its safety, tolerability, preliminary clinical effects, and drug/body interactions.
Contact Us for the Latest Status
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MC1376 Phase I Trial to Evaluate the Safety and Efficacy of Intratumoral and Intravenous Injection of Vesicular Stomatitis Virus Expressing Human Interferon Beta, and Tyrosinase Related Protein 1 (VSV-IFNb-TYRP1) in Patients with Metastatic Ocular Melanoma and Previously Treated Patients with Unresectable Stage III/IV Cutaneous Melanoma
Jacksonville, Fla.
The purpose of this study is to determine the safety profile and maximum tolerated dose (MTD) of VSV-IFNß-TYRP1 therapy when administered by IV and IT injection in patients with previously treated metastatic melanoma.
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MMP1602: Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252
Jacksonville, Fla.
The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.
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PT-112-101, A Phase I, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects with Advanced Solid Tumors
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to determine the maximum tolerated dose, and evaluate its safety, tolerability, preliminary clinical effects, and drug/body interactions.
Closed for Enrollment
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A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma
Jacksonville, Fla.,
Rochester, Minn.
This phase II trial studies how well glembatumumab vedotin works in treating patients with middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the body (metastatic) or has returned at or near the same place after a period of time during which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink the tumor by binding to tumor cells and delivering tumor-killing substances to them.
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A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects With Advanced/Unresectable or Metastatic Urothelial Cancer
Jacksonville, Fla.,
Rochester, Minn.
This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants, in participants whose tumors rely on programmed cell death ligand 1 (PD-L1) protein (PD-L1-positive tumors), and in participants with strongly PD-L1-positive tumors.
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A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Rochester, Minn.,
Jacksonville, Fla.
This phase II, single-arm study was designed to evaluate the effect of MPDL3280A treatment in patients with locally advanced or metastatic urothelial bladder cancer. Patients will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of patients who are treatment-naïve and ineligible for platinum-containing therapy. Cohort 2 will contain patients who have progressed during or following a prior platinum-based chemotherapy regimen. Patients in both cohorts will be given a 1200 mg intravenous (IV) dose of MPDL3280A on Day 1 of 21-day cycles. Treatment may continue for up to 16 cycles or 12 months, whichever is first, in the absence of toxicity or disease progression. Patients will be followed for up for 2 years. Patients who complete the initial treatment stage of up to 16 cycles may be eligible for MPDL3280A re-treatment upon subsequent disease progression during the follow-up period and without intervening systemic anti-cancer therapy.
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A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to determine whether Nivolumab in combination with Relatlimab is more effective than Nivolumab by itself in treating unresectable Melanoma or Melanoma that has spread
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Analysis of Immune System Dynamics in Patients with Surgically Resected Early Stage (I-IIIA) Melanoma
Rochester, Minn.
The purpose of this study is to identify melanoma patients that have a pattern or cycle when the immune system is more active in fighting cancer cells and see if treating melanoma at certain times in that cycle may be more effective.
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Expanded Access of MK-3475 in Metastatic Melanoma Patients With Limited to No Treatment Options
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This is an expanded access program (EAP) for participants who have progressed after prior systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated. Participants cannot be eligible for or have participated in any pembrolizumab (MK-3475) clinical trial with the exception of a participant enrolled in the pembrolizumab protocol MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed; such participants will be eligible to participate in the EAP, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for MK-3475-030 are met.
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Identifying a Panel of Potential Biomarkers to Predict Response to Anti PD-1 Therapy (PDL-1, PDL-2, TILs, PD-1, MSI, SPI-6 and SPI-CI, Bcl-2, Bim, Ki-67 )
Rochester, Minn.
The purpose of this study is to identify a panel of possible biomarkers to predict response to anti PD-1 therapy by establishing the progression free survival rate at 6 months for cancer patients treated with anti PD-1 medications, then perform biopsies for biomarkers on saved tissue samples from these patients.
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