Avelumab for Cancer

Recruiting at 105 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: EMD Serono Research & Development Institute, Inc.

Must be taking: Avelumab

Disqualifiers: Pregnancy, Breastfeeding, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

205 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.

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.

What data supports the effectiveness of the drug Avelumab for cancer treatment?

Avelumab has been approved in the USA for treating metastatic Merkel cell carcinoma and metastatic urothelial carcinoma, showing it can help control these cancers. It works by blocking a protein that usually helps cancer cells hide from the immune system, allowing the body to better fight the cancer. ^{1 2 3 4 5}

Is Avelumab safe for humans?

Avelumab, also known as Bavencio, has been studied for safety in various cancers, including Merkel cell carcinoma and urothelial carcinoma. It is generally considered safe, but like many treatments, it can cause side effects, including immune-related adverse events (unwanted effects on the immune system). ^{1 2 5 6 7}

How is the drug Avelumab different from other cancer treatments?

Avelumab is unique because it is a monoclonal antibody that blocks PD-L1, a protein that helps cancer cells evade the immune system, allowing the body's T cells to attack the cancer. It is administered intravenously and is specifically approved for treating certain advanced cancers like Merkel cell carcinoma and urothelial carcinoma. ^{1 2 8 9 10}

Research Team

Medical Responsible

Principal Investigator

Merck KGaA, Darmstadt, Germany

Eligibility Criteria

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

My treatment is associated with Merck Serono in Japan.

Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists

I meet other specific requirements for the trial.

Exclusion Criteria

Participants who are pregnant or breastfeeding

Participant has been enrolled in the comparator arm of avelumab parent study

I am allergic to one or more ingredients in the study treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Long-term

Treatment Details

Interventions

• Avelumab

Trial Overview 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.

Participant Groups

Group I: Avelumab Experimental Treatment 1 Intervention

Avelumab is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Bavencio for:

• Merkel cell carcinoma
• Renal cell carcinoma
• Urothelial carcinoma

Approved in United States as Bavencio for:

• Merkel cell carcinoma
• Renal cell carcinoma
• Urothelial carcinoma

Approved in Japan as Bavencio for:

• Merkel cell carcinoma
• Renal cell carcinoma
• Urothelial carcinoma

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials

86

Recruited

22,700+

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

Trials

449

Recruited

122,000+

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

Findings from Research

Avelumab is an antibody that blocks programmed cell death ligand-1 (PD-L1) and has received accelerated approval in the USA for treating metastatic Merkel cell carcinoma (mMCC) in both adults and children aged 12 and older.

The drug is also undergoing regulatory reviews for other cancer treatments, including urothelial carcinoma, indicating its potential as a versatile cancer therapy in various stages of development worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avelumab: First Global Approval. Kim, ES.[2022]

Avelumab, a monoclonal antibody targeting PD-L1, demonstrated an acceptable safety profile in a phase 1a trial with 53 patients, with only one dose-limiting toxicity observed at the highest dose of 20 mg/kg, indicating that the maximum tolerated dose was not reached.

The pharmacokinetic analysis showed a dose-proportional exposure and a half-life of approximately 4 days at higher doses, leading to the selection of 10 mg/kg every 2 weeks for further development, as it achieved over 90% target occupancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Heery, CR., O'Sullivan-Coyne, G., Madan, RA., et al.[2022]

Avelumab maintenance therapy after platinum-based chemotherapy in advanced urothelial carcinoma significantly improves overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), especially in patients with PD-L1 positive tumors, compared to those receiving best supportive care.

While avelumab is effective, it is associated with a high rate of treatment-related adverse events (TRAEs) in 86.7% of patients, with 32.4% experiencing severe adverse events, indicating the need for careful patient monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Avelumab in the Treatment of Advanced Urothelial Carcinoma: Focus on Patient Selection and Outcomes. Ten Eyck, JE., Kahlon, N., Masih, S., et al.[2022]

Avelumab, an immune checkpoint inhibitor used for treating Merkel cell carcinoma, can lead to rare but severe neurological adverse effects, as demonstrated in a case of a 70-year-old man who developed diplopia and later severe demyelinating polyneuropathy after treatment.

The neurological complications observed in this patient were refractory to multiple immune suppressive treatments, highlighting the need for awareness of potential severe side effects associated with avelumab therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Demyelinating Polyneuropathy and Cranial Neuropathy During Avelumab Treatment of Metastatic Merkel Cell Carcinoma. Bilić, H., Sitaš, B., Hančević, M., et al.[2021]

Avelumab, a PD-L1 inhibitor, has shown overall response rates for advanced Merkel cell carcinoma (MCC) ranging from 29.1% to 72.1% in real-world studies, with median progression-free survival between 8.1 to 24.1 months, indicating its efficacy across diverse populations.

The treatment is generally safe, with common side effects including fatigue and infusion-related reactions, and it appears to be particularly effective in immunosuppressed patients, although further research is needed to evaluate long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avelumab for Advanced Merkel Cell Carcinoma: Global Real-World Data on Patient Response and Survival. Lohray, R., Verma, KK., Wang, LL., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Avelumab: First Global Approval. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Product review: avelumab, an anti-PD-L1 antibody. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Avelumab in the Treatment of Advanced Urothelial Carcinoma: Focus on Patient Selection and Outcomes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and immune-related adverse event associations in avelumab-treated patients. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Severe Demyelinating Polyneuropathy and Cranial Neuropathy During Avelumab Treatment of Metastatic Merkel Cell Carcinoma. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of first-line avelumab in patients with advanced non-small cell lung cancer: results from a phase Ib cohort of the JAVELIN Solid Tumor study. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Avelumab for Advanced Merkel Cell Carcinoma: Global Real-World Data on Patient Response and Survival. [2023]