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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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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 |
A Global, Multicenter, Randomized, Placebo-Controlled Phase 3 Trial to Compare the Efficacy and Safety of Fruquintinib Plus Best Supportive Care to Placebo Plus Best Supportive Care in Patients with Refractory Metastatic Colon Cancer (FRESCO-2) |
Primary objective:
To evaluate the overall survival of fruquintinib plus BSC compared to placebo plus BSC in subjects with refractory mCRC.
Inclusion Criteria:
- Provide written informed consent;
- Age >=18 years;
- Histologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;
- Subjects must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Subjects are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Subjects who have been treated with both TAS-102 and regorafenib are permitted. Subjects must also have been
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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 Phase 2 Study of Neoadjuvant Cemiplimab for Stage II TO IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC) |
Primary outcome measures:
Pathologic complete response (pCR) rate assessed by independent central pathology review [Time Frame: Up to 12 weeks]
Secondary outcome measures:
- Major pathologic response (mPR) rate assessed by independent central pathology review [Time Frame: Up to 12 weeks]
- pCR rate assessed by local pathology review [Time Frame: Up to 12 weeks]
- mPR rate assessed by local pathology review [Time Frame: Up to 12 weeks]
- Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1 [Time Frame: Up to 12 weeks]
- Event free survival (EFS) [Time Frame: Up to 50 months]
- Disease free survival (DFS) [Time Frame: Up to 47 months]
- Overall survival (OS) [Time Frame: Up to 50 months]
- Incidence of adverse events (AEs) [Time Frame: Up to 52 months]
- Incidence of serious adverse events (SAEs) [Time Frame: Up to 52 months
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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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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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Urological Oncology Program |
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study |
Primary objective:
To compare the overall survival (OS) in patients with metastatic RCC treated with ipilimumabnivolumab followed by either nivolumab versus cabozantinib-nivolumab.
Secondary objectives:
- To determine PFS of patients treated with nivolumab versus nivolumab-cabozantinib
- To evaluate the 12-month complete response rate in patients treated with ipilimumabnivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab (patients who have CR and relapse before 12 months will not be counted as a CR at 12-months)
- To evaluate the rates of discontinuing therapy at 1 year
- To compare objective response rates (ORR, assessed by RECIST 1.1 and irRECIST criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab.
- To document the adverse event profile of ipilimumab-nivolumab
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Urological Oncology Program |
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer) |
Primary objective:
To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone.
Secondary objectives:
- To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.
- To compare the rate of symptomatic local progression between the treatment arms.
- To compare progression-free survival (PFS) between the two treatment arms.
- To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites.
Inclusion Criteria:
- All patients must have a histologically or cytologically proven
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