Nivolumab and rHuPH20 for Carcinoma, Renal Cell

Phase-Based Estimates
2
Effectiveness
3
Safety
Hospital Marques de Valdecilla, Santander, Spain
Carcinoma, Renal Cell+2 More
Nivolumab and rHuPH20 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Renal Cell

Study Summary

This study is evaluating whether a drug which targets cancer cells may help treat kidney cancer.

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Eligible Conditions

  • Carcinoma, Renal Cell
  • Carcinoma
  • Clear Cell Renal Cell Carcinoma (ccRCC)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

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.

At 28 days
Trough serum concentration at day 28 (Cmind28)
Up to 2 years
Incidence of AEs leading to discontinuation
Year 3
Incidence of adverse events (AEs)
Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of local injection- or infusion-site reactions
Incidence of serious adverse events (SAEs)
Percentage of participants who develop anti-nivolumab antibodies, if applicable
Percentage of participants who develop neutralizing antibodies, if applicable
Year 6
Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up
Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up
Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up
Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up
Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up
Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up
Up to 28 days
Time-averaged serum concentration over 28 days (Cavgd28)
Up to 3 years
Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up
Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up
Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up
Efficacy parameters: OS with a minimum of 12 months follow-up
Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up
Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up
Up to 4 months
Peak serum concentration at steady-state (Cmaxss)
Steady-state average serum concentration (Cavgss)
Trough serum concentration at steady-state (Cminss)
Up to 5 years
Efficacy parameters: DCR by BICR at end of study
Efficacy parameters: DOR by BICR at end of study
Efficacy parameters: ORR by BICR at end of study
Efficacy parameters: OS at end of study
Efficacy parameters: PFS by BICR at end of study
Efficacy parameters: TTR by BICR at end of study
Incidence of deaths
Up to 7 days
Maximum serum concentration after the first dose (Cmax1)
Time to peak serum concentration after the first dose (Tmax1)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Arm B: Intravenous Nivolumab
Arm A: Subcutaneous Nivolumab

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.

Arm A: Subcutaneous Nivolumab
Biological
Arm B: Intravenous Nivolumab
Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Local Institution - West Reading, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If you have advanced RCC or metastatic RCC, your cancer is not amenable to surgery or radiation therapy that could cure your cancer. show original
The text is about a study that is going to randomize people with measurable disease show original
The study participants were intolerant to their last treatment regimen and within 6 months of the start of the study, they were intolerant to other treatment regimens. show original
For more information on how to participate in a Bristol-Myers Squibb clinical trial, please visit www.BMSStudyConnect.com show original
Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
The patient has a Karnofsky performance status of ≥ 70 at screening. show original
Must agree to follow any specific methods of contraception required by our program, if applicable. show original
Only received two other types of treatments before this one. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get carcinoma, renal cell a year in the United States?

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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.

Unverified Answer

What causes carcinoma, renal cell?

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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.

Unverified Answer

Can carcinoma, renal cell be cured?

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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.

Unverified Answer

What is carcinoma, renal cell?

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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.

Unverified Answer

What are the signs of carcinoma, renal cell?

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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.

Unverified Answer

What are common treatments for carcinoma, renal cell?

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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.

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Does carcinoma, renal cell run in families?

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[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.

Unverified Answer

Who should consider clinical trials for carcinoma, renal cell?

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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.

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What is the survival rate for carcinoma, renal cell?

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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.

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What are the common side effects of nivolumab and rhuph20?

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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.

Unverified Answer

What is the average age someone gets carcinoma, renal cell?

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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.

Unverified Answer

Is nivolumab and rhuph20 safe for people?

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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.

Unverified Answer
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