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Monoclonal Antibodies
Avelumab for Thymic Cancer
Phase 2
Recruiting
Led By Arun Rajan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have advanced, unresectable disease that is not amenable to surgical resection
Participants must have had at least one prior line of platinum-based chemotherapy or participant must have refused cytotoxic chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every other cycle
Awards & highlights
Study Summary
This trial is testing if the drug avelumab is safe and well-tolerated, and is effective in treating relapsed or refractory thymoma and thymic carcinoma.
Who is the study for?
Adults over 18 with thymoma or thymic carcinoma that's worsened after platinum chemotherapy can join. They need at least one measurable tumor and good organ/marrow function. They must not be pregnant, agree to use effective contraception, and have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory).Check my eligibility
What is being tested?
The trial is testing Avelumab's safety and effectiveness for those whose cancer has returned post-chemotherapy. Participants will receive Avelumab infusions every two weeks, possibly alongside pre-medications like Benadryl and Tylenol to reduce infusion reactions.See study design
What are the potential side effects?
Avelumab may cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, possible blood abnormalities, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition cannot be treated with surgery.
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I have had platinum-based chemotherapy or refused it.
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My cancer is confirmed to be thymoma or thymic carcinoma.
Select...
My organ and bone marrow functions are normal.
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I am fully active or have some restrictions but can still care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of death
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of death
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) based on RECIST 1.1 criteria
Safety and tolerability of Avelumab based on NCI-CTCAE v4.0
Secondary outcome measures
Duration of Response
Immune-related progression-free survival (irPFS)
Overall Survival (OS)
Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Investigations
6%
Metabolism and nutrition disorders
6%
General disorders and administration site conditions
6%
Gastrointestinal disorders
6%
Nervous system disorders
6%
Cardiac disorders
6%
Infections and infestations
6%
Endocrine 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: Arm 1 AvelumabExperimental Treatment1 Intervention
Avelumab will be administered at a dose of 10 mg/kg intravenously once every two weeks until disease progression or development of intolerable adverse events.
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?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,799 Total Patients Enrolled
9 Trials studying Thymic Carcinoma
944 Patients Enrolled for Thymic Carcinoma
Arun Rajan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,681 Total Patients Enrolled
3 Trials studying Thymic Carcinoma
722 Patients Enrolled for Thymic Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that are causing symptoms.My condition cannot be treated with surgery.I have had PD-1 or PD-L1 therapy without severe side effects or disease worsening.I haven't taken immunosuppressive drugs in the last 28 days.I have had PD-1 or PD-L1 therapy without severe side effects or disease worsening.I haven't had any other cancer in the past 2 years.I am fully active and can carry on all pre-disease activities without restriction.I have advanced cancer that can't be removed by surgery and have tried or refused chemotherapy.You have a measurable lesion by RECIST 1.1.1.I haven't had vaccines for infection prevention within the last 4 weeks.I have had platinum-based chemotherapy or refused it.My cancer is confirmed to be thymoma or thymic carcinoma.I am 18 years old or older.I haven't used hormonal agents for thymic cancer in the last 7 days.I am using highly effective birth control methods.I am legally unable to make my own decisions.I have not had major surgery in the last 28 days.I have had an organ or stem-cell transplant.I have a serious heart condition.I have tested positive for HIV or have AIDS.I am not taking any drugs that are not allowed in the study.My organ and bone marrow functions are normal.I have an autoimmune disease that could worsen with immune-stimulating treatments.I am fully active or have some restrictions but can still care for myself.I still have side effects from previous cancer treatments.I do not have any active infections needing treatment.I have not had cancer treatment in the last 28 days.I am 18 years or older and interested in the Avelumab study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 Avelumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the patient cohort engaged in this research study?
"Affirmative. Clinicaltrials.gov attests to the fact that this trial, which was first published on April 19th 2017, is currently in search of participants. Approximately 55 individuals must be recruited from a single medical facility."
Answered by AI
What safety protocols are in place for individuals utilizing Avelumab?
"After careful consideration, the safety of Avelumab was rated a 2 due to it being in Phase 2; meaning there is evidence of its security but not enough data regarding efficacy."
Answered by AI
Does this clinical investigation have any open spots for participants?
"The details posted to clinicaltrials.gov show that recruitment for this trial is ongoing, with the original post date being April 19th 2017 and its most recent revision occurring on November 10th 2022."
Answered by AI
Is this trial a pioneering endeavor in the field?
"Presently, Avelumab is being tested in 112 clinical trials spanning 1024 cities and 52 countries. EMD Serono Research & Development Institute, Inc. initiated the first study for this drug back in 2014; it included 204 participants and was able to reach Phase 2 of FDA approval stages. Since then, 48 further investigations have been completed."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Journal of Thoracic OncologyJournal
Diffuse High Intensity PD–L1 Staining in Thymic Epithelial TumorsOther Trials to Consider
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