CLINICAL TRIAL

MRx0518 for Carcinoma, Renal Cell

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Recruiting · 18+ · All Sexes · Kansas City, KS

Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors

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About the trial for Carcinoma, Renal Cell

Eligible Conditions
Renal Cell Adenocarcinoma · Oncology · Non-Small Cell Lung Carcinoma (NSCLC) · Carcinoma, Renal Cell · Neoplasms · Bladder Cancer, Cancer · Tumors, Solid · Melanoma

Treatment Groups

This trial involves 2 different treatments. MRx0518 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 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
MRx0518
DRUG
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Renal Cell or one of the other 7 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I am 18 years or older and I understand what I am signing. show original
This text is discussing evidence of advanced and/or metastatic or recurrent NSCLC, renal cell carcinoma, bladder cancer or melanoma show original
People who don't respond to standard therapy or for whom no appropriate therapies are known to provide clinical benefit (per the judgement of the Investigator). show original
Within 12 weeks of taking a PD-1/PD-L1 inhibitor, progressive disease has been documented. show original
This means that the organs in your body are functioning properly show original
The subject has demonstrated disease progression after PD-1/PD-L1 therapy as defined by RECIST v1.1, iRECIST or irRECIST show original
At least one lesion that can be measured using RECIST v 1.1 criteria. show original
Can write and agrees to a written contract about the trial. show original
samples If you are willing to provide archival tissue samples, we would be very grateful show original
The patient has received at least 2 doses of a PD-1/PD-L1 inhibitor. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 1 of Cycle 1 and Cycle 2, time of treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days), and 30 Day follow up
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 1 of Cycle 1 and Cycle 2, time of treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days), and 30 Day follow up
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1 of Cycle 1 and Cycle 2, time of treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days), and 30 Day follow up.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether MRx0518 will improve 3 primary outcomes, 1 secondary outcome, and 4 other outcomes in patients with Carcinoma, Renal Cell. Measurement will happen over the course of From start of treatment until death due to any cause up to a maximum of 35 treatment cycles (one cycle = 21 days).

Overall survival
FROM START OF TREATMENT UNTIL DEATH DUE TO ANY CAUSE UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Survival of the subjects will be recorded
FROM START OF TREATMENT UNTIL DEATH DUE TO ANY CAUSE UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Part B: To assess safety and tolerability of MRx0518 in combination with pembrolizumab through the collection of adverse events
BASELINE TO TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Adverse events will be assessed as per CTCAE v4
BASELINE TO TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Part B: To assess the clinical benefit of MRx0518 in combination with pembrolizumab
BASELINE TO TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
To determine preliminary evidence of anti-tumor activity
BASELINE TO TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Part A: To assess the safety and tolerability of MRx0518 in combination with pembrolizumab through the collection of adverse events
BASELINE TO TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Adverse events will be assessed as per CTCAE v4
BASELINE TO TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Antitumour effect
BASELINE AND EVERY 3 WEEKS UNTIL TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Antitumour effect is assessed through tumour imaging and measurement of lesions per RECIST and iRECIST (ORR, DOR, DCR, PFS)
BASELINE AND EVERY 3 WEEKS UNTIL TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Biomarkers of treatment effect - tumour
BASELINE, DAY 1 OF CYCLE 4 AND TIME OF TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
Tissue biopsies will be taken to analyse for tumour biomarkers
BASELINE, DAY 1 OF CYCLE 4 AND TIME OF TREATMENT DISCONTINUATION UP TO A MAXIMUM OF 35 TREATMENT CYCLES (ONE CYCLE = 21 DAYS)
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Patient Q & A Section

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

What are common treatments for carcinoma, renal cell?

There is a paucity of published data regarding nephrectomy in patients with RCC; hence only 5 studies were found in the literature to summarize the present data. The data reported in these studies are limited by their nonrandomized design, and the inclusion of other treatments such as chemotherapy or hormonal therapy are not specified. It was therefore concluded that there is no published evidence for the treatment of RCC patients. To our knowledge, this is the first paper to evaluate the therapeutic effects of nephrectomy on RCC treatment in a systematic manner.

Anonymous Patient Answer

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

The American Cancer Society estimates a new Diagnosis of Renal cell carcinoma will be made in 2,000 (95% CI 1,800-2,000) people in the U.S. a year.

Anonymous Patient Answer

What is carcinoma, renal cell?

Carcinoma, renal cell, is a tumour of cells known for their ability to infiltrate, form a tumour mass, and spread both locally and systemically. It is most often found in women in the second decade of life. As the tumour cell's metastatic capacities increase, the aggressiveness and eventual outcome of the tumour vary amongst patients. It affects around 10% of all patients with kidney pathology, making it one of the major reasons for nephrectomy and kidney failure. The tumour is usually treated with surgery and adjuvant radiotherapy.

Anonymous Patient Answer

Can carcinoma, renal cell be cured?

Carcinoma, renal cell can be cured but, if left untreated, cannot be avoided. Early detection allows for more effective methods of treatments, and thus the possibility for remission. But if left unrecognized the cell is more likely to spread. The possibility of cure is, however, still limited.

Anonymous Patient Answer

What causes carcinoma, renal cell?

Renal cell carcinoma typically has a gradual development over many years. The occurrence may be due to genetic, hormonal, and environmental factors. Risk factors may include lifestyle factors and occupational hazards. Histological evaluation may fail to detect early lesions. The incidence appears to be increasing with new technology, particularly in children. Most of the cases occur in the elderly. If only one kidney is affected, the prognosis is better than if there are metastatic lesions.

Anonymous Patient Answer

What are the signs of carcinoma, renal cell?

Symptoms common to renal cell carcinoma include hematuria, abdominal pain, flank pain, and flank mass on mammogram or chest x-ray. Symptoms similar to renal cell carcinoma including flank mass and hematuria may occur in patients with metastatic renal cell carcinoma. Renal cell carcinoma, as it is most often diagnosed in children, may present with non-specific abdominal or flank pain and flank mass but may rarely cause hematuria. The latter scenario might suggest adrenocortical carcinoma.

Anonymous Patient Answer

Does carcinoma, renal cell run in families?

Although it was apparent that the study of tumor families can be a powerful diagnostic tool for hereditary cancer predisposition, it was shown that a low incidence (0.5%) of the tumors occurring in this study could be attributed to the contribution of genetic factors.

Anonymous Patient Answer

How serious can carcinoma, renal cell be?

The risk of being in a severely disabled group and the frequency of cancer patients having severe [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) is high. Because a majority have experienced severe pain before the development of cancer, a diagnosis of cancer can be devastating to patients. Physicians and oncologist must educate patients with the potential for severe chronic pain related to cancer.

Anonymous Patient Answer

Have there been other clinical trials involving mrx0518?

This trial was the first to evaluate MRX0518 as a treatment for patients with advanced-stage renal cell carcinoma (ARCCR). Findings from a recent study show a very small, insignificant decrease in progression-free survival in patients receiving MRX0518 compared with placebo, which limits its potential role as a first-line treatment for ARCCR.

Anonymous Patient Answer

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

The average age at diagnosis of renal cell carcinoma is 70 years and 5 months. The median age at diagnosis is 65 years and 9 months. Average age is 68 years and 4 months for patients with papillary renal cell carcinoma"

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Anonymous Patient Answer

What are the latest developments in mrx0518 for therapeutic use?

Findings from a recent study demonstrated a safety profile for mrx0518 when administered as monotherapy or in combination with other modalities. The data suggests mrx0518 may be well-tolerated, with a manageable side-effect profile.

Anonymous Patient Answer

Is mrx0518 typically used in combination with any other treatments?

MRx0518 is typically combined with other agents. As of July 2013, only a small number of patients had been treated with MRx0518 in combination with any other agents, and it would be inappropriate to make definitive therapeutic decisions without additional information on the use of MRx0518 in combination with other agents.

Anonymous Patient Answer
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