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Monoclonal Antibodies

Avelumab for Cancer

Phase 3
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 5 years
Awards & highlights

Study Summary

This trial will monitor the safety and tolerability of avelumab in cancer patients who continue treatment with avelumab.

Who is the study for?
This trial is for patients with solid tumors who are already enrolled in an avelumab study and either continue treatment or are in follow-up. They must use effective contraception if applicable, not have allergies to the drug's ingredients, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial monitors the ongoing safety and tolerability of avelumab, a medication previously studied for treating solid tumors. Participants will maintain their current regimen from the parent study without any changes.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with drugs like avelumab include immune-related reactions, infusion responses, fatigue, skin issues, and potential impacts on liver function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 5 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
Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events
Secondary outcome measures
Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
Overall Survival (OS)
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Immune system disorders
6%
Endocrine disorders
6%
Cardiac disorders
6%
Nervous system disorders
6%
Infections and infestations
6%
Investigations
6%
Metabolism and nutrition disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: AvelumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,699 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,495 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,814 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03815643 — Phase 3
Solid Tumors Research Study Groups: Avelumab
Solid Tumors Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03815643 — Phase 3
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03815643 — Phase 3

Frequently Asked Questions

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

Does Avelumab have a high rate of adverse effects?

"Avelumab's safety is backed by both efficacy data from Phase 3 trials as well as multiple rounds of supporting safety data, so it received a score of 3."

Answered by AI

Are there any vacancies in this trial for patients who want to participate?

"This clinical trial, as stated on the website clinicaltrials.gov, is not recruiting patients at this time. The first posting was on March 22nd, 2019 and the most recent update was October 4th, 2022. It is worth noting that there are 588 other trials enrolling patients as of right now."

Answered by AI

What are some of the previous research projects that have included Avelumab?

"As of now, there are one hundred and sixteen clinical trials evaluating the efficacy of Avelumab. Out of these, ten have reached Phase 3. Most locations for these trials are in Barcelona and South dakota; however, there are three thousand six hundred and ninety-one sites worldwide where patients can enroll."

Answered by AI

Is this a new or innovative clinical trial?

"Avelumab has been trialed in 116 separate studies conducted across 52 countries and 1024 cities. The first Avelumab clinical trial was sponsored by EMD Serono Research & Development Institute, Inc. in 2014. That study completed its Phase 2 drug approval stage that year after involving 204 patients. 47 more trials have occurred since then."

Answered by AI

Are there any other research centers conducting this same trial in North America?

"Patients are currently being accepted at 28 different locations including Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast in Port Saint Lucie, Florida, Michigan State University in Lansing, Michigan, and Maryland Oncology Hematology, P.A. in Rockville, Maryland."

Answered by AI

How many individuals are being given this opportunity to participate in the clinical trial?

"No, this particular trial has completed patient recruitment. The listing for the study was first published on March 22nd, 2019 and edited for the last time on October 4th, 2022. There are currently 472 other trials involving solid tumors that are actively recruiting patients and 116 studies using Avelumab have open enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
Highlands Oncology Group
HonorHealth Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~14 spots leftby Nov 2024