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Monoclonal Antibodies

Avelumab + Axitinib vs Sunitinib for Kidney Cancer

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks up to 8 years

Awards & highlights

Study Summary

This trial is testing a new combination drug treatment for advanced kidney cancer. The new treatment is being compared to the standard treatment to see if it is more effective and has fewer side effects.

Who is the study for?

This trial is for adults with advanced renal cell carcinoma that hasn't been treated before. Participants need a sample of their tumor available, at least one measurable lesion not previously irradiated, good performance status (able to carry out daily activities), and proper organ function. People who've had certain cancer treatments or have severe heart issues, brain metastasis, allergies to monoclonal antibodies, or uncontrolled asthma can't join.Check my eligibility

What is being tested?

The study compares the effectiveness and safety of two treatments as first-line therapy: Avelumab combined with Axitinib versus Sunitinib alone in patients with advanced kidney cancer. It's a phase 3 trial where participants are randomly assigned to either treatment group.See study design

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs, infusion reactions from the drug entering the body, fatigue, liver problems like hepatitis, diarrhea or other digestive issues and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have at least one tumor that can be measured and hasn't been treated with radiation.

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My kidney cancer is advanced or has spread, and tests confirm it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival in PD-L1 positive patients

Progression Free Survival (PFS) in PD-L1 positive patients

Secondary outcome measures

Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C

Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19

Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Health State Profile

+21 more

Side effects data

From 2019 Phase 1 trial • 22 Patients • NCT03289533

77%

Hypertension

55%

Decreased appetite

50%

Dysphonia

50%

Palmar-plantar erythrodysaesthesia syndrome

41%

Weight decreased

41%

Stomatitis

32%

Constipation

32%

Malaise

32%

Hypothyroidism

27%

Dysgeusia

27%

Proteinuria

27%

Diarrhoea

27%

Pyrexia

27%

Rash

18%

Epistaxis

18%

Oedema peripheral

18%

Nasopharyngitis

14%

Nausea

14%

Pruritus

14%

Abdominal pain

14%

Insomnia

14%

Ascites

14%

Fatigue

14%

Hyperthyroidism

14%

Upper respiratory tract infection

14%

Fall

14%

Cancer pain

Vomiting

Arthralgia

Abdominal distension

Adrenal insufficiency

Abdominal discomfort

Anal erosion

Haematuria

Headache

Glossitis

Blood bilirubin increased

Oedema

Platelet count decreased

Hypoalbuminaemia

Transaminases increased

Paronychia

Contusion

Infusion related reaction

Alanine aminotransferase increased

Aspartate aminotransferase increased

Muscle spasms

Musculoskeletal pain

Gastric ulcer

Diverticulum intestinal haemorrhagic

Hepatic function abnormal

Acute myocardial infarction

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab + Axitinib

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Avelumab in combination with axitinibExperimental Treatment2 Interventions

Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.

Group II: SunitinibActive Control1 Intervention

Sunitinib given at 50 mg PO QD on schedule 4/2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab (MSB0010718C)

2017

Completed Phase 1

~80

Axitinib (AG-013736)

2017

Completed Phase 3

~1620

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,910,985 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,092,153 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02684006 — Phase 3

Frequently Asked Questions

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

What is Avelumab (MSB0010718C)'s primary purpose?

"Avelumab (MSB0010718C) is a medication that can be used to treat thyroid cancer, as well as other conditions like metastatic pancreatic neuroendocrine tumors, advanced renal cell carcinoma, and pharmacotherapy."

Answered by AI

What are the possible side effects of Avelumab (MSB0010718C)?

"Avelumab (MSB0010718C) has received a score of 3 on Power's safety scale. This is because this drug, which is currently in Phase 3 clinical trials, has both efficacy and multiple rounds of data supporting safety from past testing."

Answered by AI

How many research facilities are participating in this project?

"Currently, this study is being conducted at Novant Health Oncology Specialists in Mount Airy, North carolina; Investigational Product Center (IPC) in Irving, Texas; Anschutz Cancer Center Pavilion Pharmacy in Aurora, Colorado; and 100 other locations."

Answered by AI

Why did researchers design this clinical trial in this way?

"The purpose of this trial, which will follow patients for up to 8 years, is to evaluate Progression Free Survival (PFS) in PD-L1 positive patients. Secondary outcomes being measured include Overall Survival (OS), Disease Control (DC), and Disease Control (DC) in biomarker-positive and biomarker-negative subgroups."

Answered by AI

Are people still being accepted into the study?

"This particular clinical trial is not currently enrolling patients. The most recent update to the posting was on June 9th, 2022 and it originally went up on March 23rd, 2016. However, there are presently 380 other trials for carcinoma, renal cell and 185 studies for Avelumab (MSB0010718C) that are actively admitting participants."

Answered by AI

What other research is similar to this investigation?

"Avelumab (MSB0010718C) has a long clinical history, with the first trial taking place in 2006. Since then, it has received Phase 2 drug approval and there are now 185 live trials for Avelumab (MSB0010718C) across 1524 cities and 55 countries."

Answered by AI

What other treatments or regimens have been observed in addition to Avelumab (MSB0010718C)?

"Avelumab (MSB0010718C) was first researched in 2006 at University of Texas MD Anderson Cancer Center. Out of the completed 361 studies, there are presently 185 live studies with many taking place in Mount Airy, North carolina."

Answered by AI

How many volunteers are being enrolled in this experiment?

"This trial is no longer recruiting patients. The initial posting date was March 23, 2016 and the most recent update was June 9, 2022. There are presently 380 clinical trials actively enrolling patients with carcinoma, renal cell and 185 studies for Avelumab (MSB0010718C) admitting participants."

Answered by AI