Search Results
22-124 Main-CAV
To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had CR, PR or SD after completion of first line platinum-based chemotherapy.
Patients will be expected to come to all clinic appointments, have labs drawn on the first day of every cycle, take medications as prescribed, return all empty pill bottles and diary, and call the clinic with questions.
Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, MVAC or ddMVAC).
No prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
ECOG Performance Status of 0 or 1
Age ≥ 18 years
No known symptomatic central nervous system (CNS) metastases.
No major surgery within 4 weeks prior to randomization.
No palliative radiotherapy within 48 hours prior to patient randomization.
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
(NIVOLUMAB) AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. VEGF TKI CABOZANTINIB WITH NIVOLUMAB (PSCI# 19-109) (A031704)
The purpose of this study is to compare the usual treatment of advanced kidney cancer (treatment with ipilimumab and nivolumab followed by nivolumab alone) to the usual treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding cabozantinib to nivolumab can increase the percentage of patients alive at 3 years from 60% to 70%.
We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.We are asking you to take part in this research study because you have advanced or metastatic kidney cancer.
Age ≥ 18 years
Karnofsky performance status greater than or equal to 70%
Hemoglobin ≥8 g/dL
Platelet Count ≥ 100,000/mm3
No cancer therapy less than 28 days prior to registration; this includes radiation therapy.
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
No history of HIV or active hepatitis B/C, or tuberculosis
No uncontrolled hypertension (systolic BP >150mmHg or diastolic BP
A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) (EA8143) (PSCI 18-025)
This study is a phase 3 study that will be comparing recurrence-free survival (RFS) between patients withlocally advanced renal cell carcinoma randomly assigned toperioperative nivolumab in conjunction with radical or partialnephrectomy with patients randomized to surgery alone.
You are being asked to take part in this research study because you have cancer in your kidney, which is planned to be removed by a surgeon. The standard treatment for your disease is to remove the kidney or part of the kidney that contains the cancer by surgery. You are then monitored after surgery with imaging scans and exams to watch for any possiblesigns of recurrence (close observation)
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)
Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease.This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
VIBRANT: VIB4920 for Active Lupus Nephritis
A randomized placebo-controlled study to evaluate the efficacy and safety of VIB4920 in study participants with active lupus nephritis
Patients come for in-person visits at the Penn State Hershey main hospital location. There will be blood draws, physical exams, and questionnaires spread out across 60 weeks.
Systemic lupus erythematosus
Transplant
PSCI 23-020: EA8212 A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.After you finish your treatment, your doctor will continue to follow your condition for 5 years with a combination of cystoscopies (inserting a telescope in your bladder) and CT scans (to take images of your body) in order to detect cancer recurrence.
Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage)
Patient must have ECOG Performance Status 0-2.
Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization.
Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy
Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
Patient must not have pure squamous cell carcinoma or adenocarcinoma.
Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
PSCI 23-121 Phase III Randomized Trial of Stereotactic ablativeradiotherapy (SAbR) for Oligometastatic Advanced RenalCarcinoma (SOAR)
This study is looking at patients with oligometastasis comparing chemotherapy and SABR with chemotherapy alone
•Blood counts and blood chemistry done at initiation and every three months to make sure you are not having any side effects from the study affecting your blood counts.•CT or MRI scans done at initiation and every three months to monitor the response of the treatment to your cancer•Physical exams done every three months to confirm your general well-being and to detect side effects from the study.Compete physical and well being form as set below:•Baseline•3 months from start of treatment•6 months from start of treatment•9 months from start of treatment•12 months from start of treatment•18 months from start of treatment•24 months from start of treatment
patient may not have brain metastases
Patient may have any RCC histology except a histology that has a sarcomatoid component.
Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization.
Patient must have primary site addressed by local therapy. If the primary RCC is intact, the patient must undergo local treatment to the primary before randomization.
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
Patients must not expect to conceive until after 6 months after the last dose of protocol medication
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
In order to participate in the QOL portion of the protocol, the patient must speak English or Spanish.