Monoclonal Antibodies

Comprehensive Ablative Radiation Therapy for Neuroendocrine Carcinoma

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, NY

Comprehensive Ablative Radiation Therapy +1 morePhase 2RecruitingLed by Christoper Barker, MDResearch Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with progression in only one of several responding metastases will not be eligible

Patients with clinical deterioration during aPD1 monotherapy are eligible ≥6 weeks after starting aPD1 therapy

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upat 12 weeks

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Study Summary

This trial will test whether combining immunotherapy with radiation therapy can effectively treat Merkel cell carcinoma.

Eligible Conditions

Cutaneous Neuroendocrine Carcinoma

Eligibility Criteria

Inclusion Criteria

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

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If your cancer has spread to different areas of your body, but only one area is getting worse while the others are responding to treatment, you may not be eligible for the study.

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If you have been receiving a certain type of treatment called aPD1 therapy and your health has been getting worse, you can join the trial if it has been at least 6 weeks since you started that treatment.

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All visible areas of your MCC (Merkel cell carcinoma) can be effectively treated with radiation therapy, as determined by the radiation oncologist and principal investigator.

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Your organs and bone marrow are working normally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

progression free survival

Secondary outcome measures

overall response rate

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Avelumab and Radiation TherapyExperimental Treatment2 Interventions

Will receive avelumab at the FDA approved dose and schedule of 800 mg IV over 60 minutes every 2 weeks (+/- 3 days) until treatment intolerance or disease progression occurs or 2 years of study therapy have been administered; standard of care Avelumab therapy after 2 years is permitted. Comprehensive Ablative Radiation Therapy (CART) will be initiated between the first and second dose of Avelumab. Comprehensive ablative radiation therapy will be given according to guidelines.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

FDA approved

0 / 4Eligibility criteria met

Find a site

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,878 Previous Clinical Trials

585,087 Total Patients Enrolled

EMD SeronoIndustry Sponsor

139 Previous Clinical Trials

25,820 Total Patients Enrolled

Christoper Barker, MDPrincipal Investigator

Memorial Sloan Kettering Cancer Center

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04792073 — Phase 2

Neuroendocrine Carcinoma Research Study Groups: Avelumab and Radiation Therapy

Neuroendocrine Carcinoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04792073 — Phase 2

Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04792073 — Phase 2

Frequently Asked Questions

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

Could you explain what risks are associated with Comprehensive Ablative Radiation Therapy?

"While Phase 2 trials lack the data to support efficacy, there is some evidence that Comprehensive Ablative Radiation Therapy is safe. Thus, we give it a score of 2."

Answered by AI

Are there any slots left for volunteers in this experiment?

"This is accurate. Based on the information available from clinicaltrials.gov, this study posted on 3/8/2021 and last updated 9/21/2022 is looking for 18 participants to be enrolled at 7 different locations."

Answered by AI

What percentage of hospitals are participating in this research?

"7 different locations, including ones in Basking Ridge, Commack and New York, are currently enrolling patients for this study. To reduce the amount of travelling required, please select the closest location to you."

Answered by AI

How many men and women are enrolled in this research project?

"The clinical trial is currently ongoing, as reflected by the data on clinicaltrials.gov. It began on 3/8/2021 and was updated most recently on 9/21/2022. The study needs 18 participants who can be found at 7 sites."

Answered by AI

Have there been other tests like this one in the past?

"There have been a total of 47 clinical trials for Comprehensive Ablative Radiation Therapy since 2014. The most recent study is still active, having begun in 2020. A total of 116 studies are currently underway across 1024 cities and 52 countries."

Answered by AI

What other medical studies have there been on Comprehensive Ablative Radiation Therapy?

"At the moment, there are a total of 116 ongoing clinical trials for Comprehensive Ablative Radiation Therapy (CAR-T). 10 of these live trials are currently in Phase 3. The majority of studies related to CAR-T are based in Barcelona and South Dakota; however, there are 3692 locations worldwide where these trials are taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma

2021. "Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04792073.