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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 |
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:
-
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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Urological Oncology Program |
CASPAR - A Phase III Trial of Enzalutamide and Rucaparib as a Novel Therapy in First-line Metastatic Castration-Resistant Prostate Cancer |
Primary objective:
To compare radiographic progression-free survival (rPFS) and overall survival (OS) with enzalutamide and rucaparib versus enzalutamide alone for patients with metastatic castration resistant prostate cancer commencing first-line therapy.
Secondary objectives:
In patients commencing enzalutamide as the first-line therapy for metastatic castration resistant prostate cancer, to evaluate the effects of concurrent administration of rucaparib on:
- rPFS and OS within HRR mutant and wild-type patients
- Time to unequivocal clinical progression
- Best radiographic response using prostate cancer working group 3 (PCWG3) criteria
- Duration of overall response
- PSA response rate
- Best response by serum PSA by months 7 and 13 using categorical and continuous measures.
- Time to first symptomatic skeletal event (SSE)
- Safety and tolerability as measured by NCI
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