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Breast Cancer Program, Gastroinstestinal Cancer Program, Sarcoma and Bone Cancer Program, Thoracic Oncology Program, Urological Oncology Program |
A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV-Associated Solid Tumors, with Expansion Cohorts in HIV-Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma |
Primary objective:
Maximum tolerated dose of nivolumab [Time Frame: 56 days]
Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least >= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized.
Secondary objectives:
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Objective response rate [Time Frame: Up to 3 years]
The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma [cHL]) and their corresponding 95% confidence intervals (calculated using exact binomial ...
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Breast Cancer Program, Gastroinstestinal Cancer Program, Sarcoma and Bone Cancer Program, Thoracic Oncology Program, Urological Oncology Program |
A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV-Associated Solid Tumors, with Expansion Cohorts in HIV-Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma |
Primary objective:
Maximum tolerated dose of nivolumab [Time Frame: 56 days]
Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least >= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized.
Secondary objectives:
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Objective response rate [Time Frame: Up to 3 years]
The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma [cHL]) and their corresponding 95% confidence intervals (calculated using exact binomial ...
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Gastroinstestinal Cancer Program |
A randomized phase II study of gemcitabine and nab-pacitaxel compared with 5 fluorouracil and lipsomal irnotecan in older patients with treatment naïve metastatic pancreatic cancer |
Primary outcome measurements:
Overall survival (OS) [Time Frame: Up to 2 years post treatment]
Secondary outcome measurements:
Instrumental Activities of Daily Living (IADL) [Time Frame: Up to 2 years post treatment]
Inclusion Criteria:
- Newly diagnosed untreated metastatic adenocarcinoma of the pancreas. However, previous surgery, adjuvant chemotherapy and/or radiation therapy will be allowed, provided radiation therapy is completed at least 2 weeks prior to registration and adjuvant therapy was administered more than 6 months prior to registration. Patients with the following histology are excluded: acinar cell; adenosquamous carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient is an English speaker with the ability to understand and complete the informed consent and questionnaires
- Leukocytes >= 3,000/mcL (obtained within 4 weeks of
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Gastroinstestinal Cancer Program |
Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS) |
Primary objective:
To compare the progression-free survival (PFS) of patients receiving high-dose cholecalciferol (vitamin D3) in combination with standard chemotherapy (leucovorin calcium, fluorouracil, and oxaliplatin [FOLFOX] or leucovorin calcium, fluorouracil, and irinotecan hydrochloride [FOLFIRI]) and bevacizumab versus those receiving standard-dose vitamin D3 in combination with standard chemotherapy and bevacizumab.
Secondary objectives:
- To compare the objective response rate (ORR) of patients receiving high-dose vitamin D3 in combination with standard chemotherapy + bevacizumab versus those receiving standard-dose vitamin D3 in combination with standard chemotherapy + bevacizumab.
- To compare the overall survival (OS) of patients receiving high-dose vitamin D3 in combination with standard chemotherapy + bevacizumab versus those receiving standard-dose vitamin D3 in combination with standard chemotherapy +
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Head and Neck Cancer Program |
Randomized Phase II/III Trial of Adjuvant Radiation Therapy With Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck |
Randomized Phase II/III Trial of Adjuvant Radiation Therapy With Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck
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Head and Neck Cancer Program |
A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC KEYNOTE-A78 |
Primary Objectives (parts C&D):
To determine the safety and tolerability of CUE-101 in combination with pembrolizumab [KEYTRUDA® (pembrolizumab) for injection, for IV use] as first-line therapy in HPV16- and HLA-A*0201-positive recurrent and/or metastatic HNSCC patients
To determine the MTD or RP2D of CUE-101 in combination with pembrolizumab [KEYTRUDA® (pembrolizumab) for injection, for IV use] as first-line therapy in HLA-A*0201, HPV16+ recurrent and/or metastatic HNSCC patients
Evaluate the PK of CUE-101 when administered in combination with pembrolizumab in first-line subjects with recurrent/metastatic HPV-driven HNSCC
Secondary Objectives:
To assess the preliminary anticancer activity of CUE-101 in combination with pembrolizumab in HPV16- and HLA-A*0201-positive recurrent and/or metastatic HNSCC patients based on RECIST version 1.1
Assess the potential immunogenicity of CUE-101 (Parts C and D)
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Head and Neck Cancer Program |
A Phase II/III Randomized Study of Maintenance Nivolumab Versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA |
Primary objective:
To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of progression-free survival (PFS). (Phase II) II. To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of overall survival (OS). (Phase III)
Secondary objectives:
- To further assess the efficacy of nivolumab compared with observation in terms of:
- The relationship of baseline PD-L1 expression to clinical outcome.
- To evaluate the association of 12 week post therapy fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) with PFS and OS.
- To establish the prognostic value of standardized uptake value (SUV)max of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS (and/or PFS).
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Cutaneous Oncology Program |
A Randomized, Placebo-Controlled, Double-Blind 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).
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Breast Cancer Program, Gastroinstestinal Cancer Program, Sarcoma and Bone Cancer Program, Thoracic Oncology Program, Urological Oncology Program |
A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV-Associated Solid Tumors, with Expansion Cohorts in HIV-Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma |
Primary objective:
Maximum tolerated dose of nivolumab [Time Frame: 56 days]
Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least >= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized.
Secondary objectives:
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Objective response rate [Time Frame: Up to 3 years]
The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma [cHL]) and their corresponding 95% confidence intervals (calculated using exact binomial ...
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Breast Cancer Program, Gastroinstestinal Cancer Program, Sarcoma and Bone Cancer Program, Thoracic Oncology Program, Urological Oncology Program |
A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV-Associated Solid Tumors, with Expansion Cohorts in HIV-Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma |
Primary objective:
Maximum tolerated dose of nivolumab [Time Frame: 56 days]
Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least >= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized.
Secondary objectives:
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Objective response rate [Time Frame: Up to 3 years]
The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma [cHL]) and their corresponding 95% confidence intervals (calculated using exact binomial ...
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