Avelumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and tolerability of avelumab for individuals with solid tumors, building on a previous study. Researchers are testing avelumab to determine its effectiveness in managing these cancers. Participants currently involved in an avelumab study, either receiving treatment or under long-term survival monitoring, might be suitable for this trial. As a Phase 3 trial, it serves as the final step before potential FDA approval, providing participants an opportunity to contribute to the validation of a promising cancer treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on participants already receiving avelumab, so it's best to discuss your specific situation with the study team.
Is there any evidence suggesting that avelumab is likely to be safe for humans?
A previous study found avelumab to be safe for patients who had already received many treatments. These patients tolerated avelumab well, even after extensive prior therapy. Research has also shown that avelumab is safe and effective for patients with advanced cancers, such as Merkel cell carcinoma.
Real-world data supports these findings, confirming that avelumab is safe when combined with other treatments for kidney cancer. Avelumab has already received FDA approval for certain types of cancer, indicating it has passed strict safety checks for those uses. Overall, avelumab is considered well-tolerated and a promising option for many patients with solid tumors.12345Why do researchers think this study treatment might be promising?
Avelumab is unique because it is an immunotherapy treatment that works by blocking the PD-L1 protein, which helps cancer cells hide from the immune system. Unlike traditional treatments such as chemotherapy and radiation, which target cancer cells directly, Avelumab empowers the body's immune system to recognize and attack cancer cells. Researchers are excited about Avelumab because it has the potential to produce a more durable response with possibly fewer side effects compared to conventional therapies. This new mechanism of action offers hope for more effective, personalized cancer treatments.
What is the effectiveness track record for avelumab in treating solid tumors?
Research has shown that avelumab, the treatment under study in this trial, effectively treats certain cancers. Specifically, studies found that patients with metastatic Merkel cell carcinoma who used avelumab experienced positive outcomes. In another study, survival rates were encouraging, with about 80.6% of patients alive six months after starting treatment and 69.1% alive at 12 months. Additionally, real-world studies demonstrated that many patients had a complete or partial response to avelumab after chemotherapy. This suggests that avelumab can be a viable option for some cancer patients.13567
Who Is on the Research Team?
Medical Responsible
Principal Investigator
Merck KGaA, Darmstadt, Germany
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants continue treatment with avelumab under the same regimen as in the parent study
Follow-up
Participants are monitored for safety and tolerability of avelumab
What Are the Treatments Tested in This Trial?
Interventions
- Avelumab
Avelumab is already approved in European Union, United States, Japan for the following indications:
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
Miguel Fernández Alcalde
EMD Serono Research & Development Institute, Inc.
Chief Executive Officer
Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School
Danny Bar-Zohar
EMD Serono Research & Development Institute, Inc.
Chief Medical Officer since 2022
MD
Merck KGaA, Darmstadt, Germany
Industry Sponsor
Danny Bar-Zohar
Merck KGaA, Darmstadt, Germany
Chief Medical Officer since 2022
MD
Belén Garijo
Merck KGaA, Darmstadt, Germany
Chief Executive Officer since 2021
MD