This trial is evaluating whether Nivolumab and rHuPH20 will improve 2 primary outcomes and 33 secondary outcomes in patients with Carcinoma, Renal Cell. Measurement will happen over the course of Up to 7 days.
This trial requires 454 total participants across 2 different treatment groups
This trial involves 2 different treatments. Nivolumab And RHuPH20 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
About 125,000 patients have carcinoma, renal cell a year in the United States. This is about 3 times the number of patients with other malignancies.
Most renal cell carcinomas seem to arise from small tumours, mainly in the upper section of the kidney and are not in any way hereditary, even though they may be associated with other hereditary cancers of the same type such as papillary or other medullary types of renal cancer. Recent findings agree with those reported recently in the British population where renal cell cancers showed no evidence of familial inheritance on a basis of histological characterization. The significance of this anomaly is not presently clear, but in the light of the emerging importance of tumour biology, further research into the factors leading to renal cell carcinomas of an intermediate type may throw light on the epidemiology, tumour biology and genetics of renal cell carcinoma.
The current status of treatment of renal cell carcinoma is unsatisfactory. The most effective cure for patients is renal cell carcinoma which is curable. However, metastatic disease can be effectively treated even during its metastatic phase, and even for the patient suffering from the recurrent disease.
A number of tumors may be related to renal cell cancer (RCC), the most common type of renal tumor. The development of RCC from the other more common types of renal tumors is rare. RCCs that have been treated surgically are most likely not to recur.
Renal cell carcinoma (RCC) is not always associated with the symptoms discussed below. However, if the signs of RCC are present, it requires an immediate biopsy as RCC is associated with the signs and symptoms discussed above (palpable masses, pain, or bloody symptoms) and/or the presence of a growth on ultrasonography.
As one would expect from the relatively non-advanced nature of many renal carcinoma patients, metastatic renal carcinoma often responds to treatments for metastatic disease, and in some cases, renal carcinoma patients benefit from antiangiogenic agents.
[Cancer of the renal cell, which is associated mainly with X-linked polycystic kidney disease, is a common disease in this family.] There is likely an autosomal dominant mode of inheritance with incomplete penetrance.
These data suggest that a substantial proportion of advanced cancer patients may benefit from clinical trials. The high prevalence of significant pain and the need for palliative therapy suggest that it is time to consider prescribing trials for cancer. The high quality of life seen in many patients with metastatic cancer would also support this strategy in this challenging population. Recent findings and those of others support the need to increase participation in cancer clinical trials, even in the palliative setting.
The survival rate for urothelial carcinoma of the renal system is low. In patients with stage I disease, adjuvant chemotherapy seems to be associated with improved survival. Larger studies are needed to determine the role of chemotherapy in the treatment of urothelial carcinoma of the kidney.
The common side effects of nivolumab and rhuph20 include fatigue, a low-grade fever, chills, decreased appetite, dizziness, headache, joint pain, itching, and muscle aches. This information should be brought to light to both physicians and patients.
The incidence of carcinomas in a particular patient is not necessarily related to his or her average age, so that the following results may be of interest. Of all renal cell carcinomas the papillary type was the most common in all age groups. The incidence of renal cell carcinomas in an average patient in our institution is about 50 per 100,000 population per year. The average time from diagnosis to death in the whole cohort of renal cell carcinoma patients was 27.5 months. For this particular patient the average time was 29.4 months for renal cell carcinoma in the first renal unit and 38.3 months for renal cell carcinoma outside this unit. In a recent study, findings do not necessarily indicate how long a patient lived.
Based on the data from clinical trials, the addition of nivolumab and rhuph20 is not associated with increased risk of any hypersensitivity reactions for any patient, even in patients with previous hypersensitivity to other human proteins. Therefore, no dose adjustments are required in patients with previous experience of hypersensitivity to other human proteins, and no additional monitoring for hypersensitivity is needed.