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Immunotherapy

Immunotherapy + Radiotherapy for Merkel Cell Carcinoma (iPRRT Trial)

Q: Is the combination of pembrolizumab and lutetium Lu177 considered sanctioned by the FDA?

<p>The safety of <a href="https://www.withpower.com/clinical-trials/experimental">Experimental</a>: Pembrolizumab + Lutetium Lu177 was rated a 2 since there is some evidence to back up its security, but none that confirm its efficacy yet.</p>

Phase 2

Recruiting

Led By Pashtoon M Kasi, MD, MS

Research Sponsored by Pashtoon M. Kasi

Eligibility Criteria Checklist

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

Must have

Presence of somatostatin receptors by Ga-68 dotatate imaging, which is a requirement for PRRT (lutetium Lu 177 dotatate [Lutathera®]). Must have at least one measurable lesion per RECIST 1.1.

ECOG Performance Status of 0-1 within 28 days prior to registration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

iPRRT Trial Summary

This trial studies the effects of combining a drug (pembrolizumab) that helps the immune system fight cancer with a radioactive drug (Lutathera) to treat Merkel cell carcinoma.

Who is the study for?

Adults with Merkel cell carcinoma who have somatostatin receptors and progressed after anti-PD-1/L1 therapy can join. They must be in good health, understand the study, and use contraception if of childbearing potential. Excluded are those with severe allergies to pembrolizumab, active infections or autoimmune diseases, recent live vaccines, organ transplants, other cancers within 3 years (except certain skin cancers), brain metastases requiring steroids, significant heart disease or HIV.Check my eligibility

What is being tested?

This Phase II trial tests a combination of pembrolizumab (an immunotherapy drug) and lutetium Lu 177 dotatate (a radioactive drug) on patients with Merkel cell cancer. Pembrolizumab boosts the immune system's cancer fight; Lutathera kills cancer cells but isn't FDA-approved for this cancer type yet.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs (immunotherapy-related), radiation toxicity from Lutathera affecting kidneys or bone marrow, fatigue, nausea, and increased risk of infection.

iPRRT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer shows somatostatin receptors and has at least one measurable lesion.

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I have been mostly active and able to carry on all pre-disease activities without restriction in the last 28 days.

Select...

My cancer is confirmed to be Merkel cell carcinoma.

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I have recovered from previous cancer treatments, except for hair loss.

Select...

I am willing to use birth control or abstain from sex as required.

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My cancer got worse despite treatment with specific immune therapy.

iPRRT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Objective Response Rate (ORR)

Secondary outcome measures

Overall survival (OS)

Progression free survival (PFS)

iPRRT Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Pembrolizumab + Lutetium Lu177Experimental Treatment2 Interventions

All patients will receive pembrolizumab once every 6 weeks + Lutetium Lu177 dotatate once every 2 months Pembrolizumab Cycle=6 weeks (for up to 2 years) Lutetium Lu177 dotatate Cycle=2 months (4 doses total)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

GI Research FoundationUNKNOWN

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,721,017 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,128 Total Patients Enrolled

Media Library

Pembrolizumab (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05583708 — Phase 2

Neuroendocrine Carcinoma Research Study Groups: Experimental: Pembrolizumab + Lutetium Lu177

Neuroendocrine Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05583708 — Phase 2

Pembrolizumab (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583708 — Phase 2

Frequently Asked Questions

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

Is enrollment for this medical experiment still open?

"The trial is not actively enrolling at this time, however the listing on clinical trials.gov reveals that it was initially uploaded on July 1st 2023 and last revised June 28th 2023. Fortunately, there are 53 other medical studies in search of candidates currently."

Answered by AI

Is the combination of pembrolizumab and lutetium Lu177 considered sanctioned by the FDA?

"The safety of Experimental: Pembrolizumab + Lutetium Lu177 was rated a 2 since there is some evidence to back up its security, but none that confirm its efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer

Pashtoon M. Kasi 2023. "Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05583708.

All > Merkel Cell Carcinoma