Lenvatinib for Metastatic Clear Cell Renal Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Metastatic Clear Cell Renal Cell Carcinoma+5 More
Lenvatinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of lenvatinib and everolimus is more effective than cabozantinib alone in treating patients with metastatic RCC.

See full description

Eligible Conditions

  • Metastatic Clear Cell Renal Cell Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Advanced Clear Cell Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic Clear Cell Renal Cell Carcinoma

Study Objectives

This trial is evaluating whether Lenvatinib will improve 1 primary outcome and 5 secondary outcomes in patients with Metastatic Clear Cell Renal Cell Carcinoma. Measurement will happen over the course of Start of study drug to death due to any cause, assessed up to 2 years.

Year 2
Overall survival (OS)
Year 2
Progression-Free Survival (PFS)
Up to 2 years
Disease Control Rate (DCR)
Health-Related Quality of Life (HRQoL)
Incidence of grade 3 or 4 adverse events
Objective Response Rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Metastatic Clear Cell Renal Cell Carcinoma

Trial Design

2 Treatment Groups

Arm B (cabozantinib)
1 of 2
Arm A (lenvatinib, everolimus)
1 of 2
Active Control
Experimental Treatment

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Lenvatinib 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.

Arm A (lenvatinib, everolimus)Patients receive lenvatinib PO QD and everolimus PO QD. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.
Arm B (cabozantinib)Patients receive cabozantinib PO QD. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from start of study drug until disease progression defined by response evaluation criteria in solid tumors (recist) 1.1, assessed up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly time from start of study drug until disease progression defined by response evaluation criteria in solid tumors (recist) 1.1, assessed up to 2 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with advanced or metastatic clear cell renal cell cancer (RCC) that is histologically or cytologically confirmed, and who have received 1 or 2 prior lines of treatment in the advanced or metastatic setting, are eligible to participate in this study show original
Patients must have a lesion that can be accurately measured in at least one dimension and is >= 15 mm with conventional techniques or >= 10 mm with more sensitive techniques show original
The patient's hemoglobin level is at least 9 grams per deciliter, so they are allowed to receive treatment or a transfusion. show original
The patient has an absolute neutrophil count of at least 1,000/microliter. show original
This means that the platelet count in the blood is at least 75,000 per microliter. show original
In Gilbert's disease, the total bilirubin level should be less than 1.5 mg/dL. show original
AST (serum glutamic-oxaloacetic transaminase) or ALT (serum glutamate pyruvate transaminase) levels should be less than 2.5 times the institutional upper limit of normal, except in cases of known hepatic metastasis, in which case the levels may be up to 5 times the institutional upper limit of normal. show original
The patient must have evidence of progression on or after treatment with a PD-1/PD-L1-containing regimen as the last treatment received within 6 months of enrollment. show original
This text means that the person has a Karnofsky performance status of >= 70, which means that they are in good or excellent health. show original
Age >= 18 years

Patient Q&A Section

What causes carcinoma?

"The most common cause of carcinoma in Africa is infection with Helicobacter pylori (H. pylori), but it is also present in those without H. pylori infection. A large number of patients have undetected gastric atrophy. Gastric carcinoma may not necessarily be related to H. pylori infection, and other factors such as diet, genetics, and lifestyle may play a role in the development of gastric carcinoma. There are no randomized controlled trials that have examined whether eradication of H. pylori decreases risk or improves survival from advanced gastric carcinoma, so it will be difficult to determine which patients might benefit from this intervention." - Anonymous Online Contributor

Unverified Answer

Has lenvatinib proven to be more effective than a placebo?

"The study did not show superiority of lenvatinib over a placebo for OS and PFS. However, the median time to progression was significantly longer in patients on lenvatinib compared to the placebo group." - Anonymous Online Contributor

Unverified Answer

How does lenvatinib work?

"Lenvatinib exerts activity against human cancer cell lines derived from solid tumors including breast cancer, non-small cell lung cancer, and colorectal cancer. It may be a useful drug for patients with these cancers who currently have no treatment options. Further studies will determine if this drug has any benefit in people with other types of cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma?

"The overall proportion of patients receiving chemotherapy was only 7% (20% carboplatin + cyclophosphamide + epirubicin); this compares well with other studies of similar patient populations. The proportion of patients receiving chemotherapy was lowest for patients with stages I and II disease (1%). Patients who were treated with curative intent had higher overall proportions of chemotherapy than those who received palliative care." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing carcinoma?

"The likelihood of developing carcinoma increases with age. It is not uncommon to have all five risk factors present at the same time. People with a high body mass index are more likely than others to develop carcinoma, especially if their weight is increased after menopause. Cigarette smoking seems to increase the risk of developing carcinoma in both genders. The risk also increases with increasing number of cigarettes smoked. Of course, the risk decreases with quitting smoking. High blood sugar levels increase the risk of developing carcinoma. Diabetes control ameliorates the risk of developing cancer. There is an association between obesity and developing carcinoma but the reason is unknown. The risk of developing cancer increases with decreasing kidney function." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma?

"Patients who have had prior chemotherapy or curative surgery may be best suited for clinical trials, whereas patients with poor performance status, significant comorbidities, or less than two weeks' survival may present a subpopulation at risk for toxicity and failure to complete treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma?

"As surgical techniques improved, so did the survival rates of patients with squamous cell cancer; however, those with adenocarcinoma had worse outcomes. The cause of carcinoma remains unknown, but the following three hypotheses seem most plausible: 1) carcinoma develops from an existing benign lesion; 2) carcinoma develops from a pre-existing carcinoma; 3) carcinoma develops in response to a physical change (e.g., radiation or chemical exposure) in the surrounding tissue." - Anonymous Online Contributor

Unverified Answer

What does lenvatinib usually treat?

"Lenvatinib was effective in patients with advanced metastatic renal cell carcinoma (mRCC) who had received prior systemic therapy. The most common adverse events included fatigue, hypertension, nausea, vomiting, headache, diarrhea, constipation, abdominal pain, rash, hyperlipidemia, and peripheral edema. Serious adverse events were rare and included pulmonary embolism, syncope, bronchospasm, dyspnea, pleuritis, respiratory failure, pneumonitis, and thrombosis. There were no significant differences between patients who received lenvatinib monotherapy and those who received lenvatinib plus everolimus. The study was sponsored by AbbVie Inc." - Anonymous Online Contributor

Unverified Answer

Is lenvatinib typically used in combination with any other treatments?

"Lenvatinib is generally used in combination with other agents, including chemotherapy (including paclitaxel and docetaxel). The combination of lenvatinib with agents such as paclitaxel shows promise in preclinical models; however, single agent and combination studies conducted in the clinic have not shown benefit. The combination with docetaxel does not appear to improve outcomes in patients with relapsed aggressive B-cell lymphomas. These data suggest that further investigation of the combination of lenvatinib with chemotherapeutic agents, such as docetaxel, is warranted." - Anonymous Online Contributor

Unverified Answer

Is lenvatinib safe for people?

"In this exploratory analysis, lenvatinib was well tolerated and appeared to be effective as first line therapy in patients with metastatic renal cell carcinoma. Serious adverse events were infrequent; most common side effects included headache and fatigue. Findings from a recent study provides an opportunity to evaluate the safety profile of lenvatinib across different types of solid tumors." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma be?

"Carcinomas are not always fatal due to their ability to metastasize. For example, an individual diagnosed with a T1a carcinoma may have zero metastatic risk. The long term survival rate for these patients, however, is still very high (94%). A patient with a T3b carcinoma has a five year survival rate of 20%. In both cases, metastatic risk was directly related to the stage of the carcinoma. The meta-analysis showed no significant difference in survival between different histologic types of carcinoma. Overall, the results indicate that even though carcinoma is not as deadly as other cancers, it is still important to treat these cancers as aggressively as possible." - Anonymous Online Contributor

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