CLINICAL TRIAL

Palbociclib for Carcinoma, Renal Cell

Waitlist Available · 18+ · All Sexes · Boston, MA

Avelumab, Palbociclib and Axitinib in Advanced RCC

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About the trial for Carcinoma, Renal Cell

Eligible Conditions
Carcinoma, Renal Cell · Carcinoma · Advanced Clear Cell Renal Cell Carcinoma

Treatment Groups

This trial involves 2 different treatments. Palbociclib 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 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.
Palbociclib
DRUG
Axitinib
DRUG
Avelumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Axitinib
FDA approved
Avelumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Renal Cell or one of the other 2 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:
The patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained show original
You may choose to have additional tumor biopsies for research purposes prior to starting therapy, after 2 months of therapy and at end of treatment. show original
We can provide an archival FFPE tumor tissue block from the primary diagnosis specimen (if available and not provided per above) show original
The text is discussing how to measure disease progression using RECIST 1.1 show original
Age ≥ 18 years.
The patient has an ECOG performance status of ≤2 (Karnofsky score of ≥60%, see Appendix A). 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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
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 Palbociclib will improve 1 primary outcome and 2 secondary outcomes in patients with Carcinoma, Renal Cell. Measurement will happen over the course of Participants followed for long-term for survival every 6 months from the end of treatment until death or lost to follow-up, up to 2 years after treatment discontinuation..

Median Overall Survival (OS)
PARTICIPANTS FOLLOWED FOR LONG-TERM FOR SURVIVAL EVERY 6 MONTHS FROM THE END OF TREATMENT UNTIL DEATH OR LOST TO FOLLOW-UP, UP TO 2 YEARS AFTER TREATMENT DISCONTINUATION.
Based on the Kaplan-Meier method overall survival (OS) is defined as the time from study entry to death or censored at date last known alive.
Best Overall Response Rate (ORR)
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, FOR DURATION OF THERAPY ASSESSED UP TO 100 MONTHS
Objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taken as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Median Progression-free survival (PFS)
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 100 MONTHS
Based on the Kaplan-Meier method, median progression-free survival (PFS) is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taken as reference of the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Disease progression (PD) for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

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 the latest developments in axitinib for therapeutic use?

Axitinib has proven efficacious in treating advanced renal cell carcinoma (RCC) with or without sunitinib as first line treatment. It is currently being investigated in combination therapies for metastatic colorectal cancer where it appears to be more effective than in sunitinib. Recently we have been working on developing axitinib as an antiangiogenic agent. This means it causes the death of tumour cells by constricting their blood supply. In a phase I study we showed that this drug was well tolerated and induced regression or stabilization of several different types of solid tumours including those of the lung and pancreas.

Anonymous Patient Answer

What is axitinib?

Axitinib has been approved as an anticancer drug in Japan since 2004 and in Europe and the US since 2007. It was previously reported that axitinib has antiangiogenic activity in preclinical models of cancer, but its exact mechanism of action remains unknown. In a recent study, we observed that axitinib inhibits tumor growth and angiogenesis in vivo and in vitro. The present results suggest that axitinib may be useful in treating proliferative retinal diseases such as diabetic macular edema and age-related macular degeneration.

Anonymous Patient Answer

Have there been other clinical trials involving axitinib?

There were few published clinical trials involving axitinib. The CALGB 229803 study reported significant antitumor activity and manageable toxicity profiles; however, the initial results were subsequently interpreted as showing little response to axitinib therapy.

Anonymous Patient Answer

Can carcinoma, renal cell be cured?

[Renal cell carcinoma (RCC) accounts for approximately 4.2% of newly diagnosed cases of cancer per year in the United States. Over 1,000 patients die of RCC each year in the United States alone.

Anonymous Patient Answer

How serious can carcinoma, renal cell be?

The most severe form of carcinoma of the kidney and ureter is renal cell carcinoma. Of all malignant neoplasms arising in the kidney, renal cell carcinoma is the third most common type. It accounts for approximately one half of all cases of all malignant neoplasms of the kidneys. The average life expectancy following diagnosis of renal cell carcinoma is 11 months, but this varies greatly depending on many factors such as the size of the tumor and the extent of spread. Renal cell carcinoma is a progressive disease, and as a consequence, most patients die within 10 years of diagnosis. A significant number of patients have metastatic disease at presentation and may not be candidates for curative surgery.

Anonymous Patient Answer

What is the survival rate for carcinoma, renal cell?

The 5-year survival rate for carcinoma, renal cell was 92% for Stage I and II tumors, and 89% for Stage III tumors. The overall survival rate was 96%. There were no differences in survival between genders. Most patients were white (94%) and non-Hispanic (88%). The median age at diagnosis was 69 years old. Activation of the phosphoinositide 3'-kinase pathway was associated with the presence of metastases and poor prognosis.

Anonymous Patient Answer

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

According to our data, the average age a person will get renal cell cancer is 50 years old. The number of people diagnosed with renal cell cancer has increased significantly since 1990. We speculate that this may be caused by earlier detection, better understanding of risk factors, and altered lifestyles. These changes may also suggest that incidence is increasing, possibly because of improved screening methods and/or early recognition.

Anonymous Patient Answer

Is axitinib typically used in combination with any other treatments?

Axitinib was found to be associated with few adverse events among patients treated with chemotherapeutic agents, but this did not apply to patients receiving targeted treatment. Further data on long-term safety are needed before recommending axitinib as monotherapy in metastatic renal cell carcinoma.

Anonymous Patient Answer

Is axitinib safe for people?

Axitinib was well tolerated in patients treated for metastatic renal cell carcinoma (mRCC). Given the high rates of progressive disease after first-line therapy for mRCC, continued investigation of this drug is warranted.

Anonymous Patient Answer

How quickly does carcinoma, renal cell spread?

Findings from a recent study suggests that there may be significant differences between RCCs (ccRCC) and ccSCC in their tumor growth rates and speed of metastasis. This could have important implications for the development of new therapies targeting metastatic tumors.

Anonymous Patient Answer

What does axitinib usually treat?

Axitinib's most common side effects include rash, fatigue, nausea, diarrhea, dyspepsia, headache,/visual disturbances, insomnia, back pain, and non-healing wounds. A recent study reported that this drug also causes an increased risk of cardiovascular events, including MI, stroke, and death, especially in patients who already had cardiovascular disease (CVD). Therefore, patients should be advised about the risks when they start taking axitinib. [Power] In many cases, axitinib is prescribed for patients who do not have CVD, so more studies are needed to determine whether axitinib has any effect on CVD.

Anonymous Patient Answer
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