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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05583708
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Merkel Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 400mg IV
  • Lutetium Lu 177 dotatate — DRUG
    7.4GBq (200 mCi) IV

Study Details

The purpose of this study is to find out what effects an immunotherapy drug, called pembrolizumab, combined with a radioactive drug, called lutetium Lu 177 dotatate (Lutathera®) have on patients with Merkel cell carcinoma. Pembrolizumab works by helping patient's immune system to fight cancer. Lutathera works by killing cancer cells. Pembrolizumab is approved by the FDA to treat Merkel cell cancer and has caused some Merkel cell cancers to shrink and/or resolve. Lutathera is FDA-approved to treat some neuroendocrine tumors and has caused some patient's neuroendocrine tumors to shrink and allowed them to live longer, but it is not approved by the FDA to treat Merkel cell cancer. The combination of Lutathera and pembrolizumab to treat Merkel cell cancer is investigational, which means this combination is not approved by the FDA to treat Merkel cell cancer.

Key Dates

Start date
Aug 3, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Pembrolizumab + Lutetium Lu177
    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)

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Christine Etler
[email protected]
Douglas Laux, MD MS (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine/NewYork-Presbyterian HospitalNew YorkNew York10065
Mahelia Bissassar
[email protected]
646-962-7669
Myriam Elizaire-Williams
Anna Pavlick, D.O. (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Marissa Weiss
[email protected]
608-262-0439
Randal Kimple, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in Iowa City, IA

By research site
University of Iowa Hospitals and Clinics· Iowa City, IAWeill Cornell Medicine/NewYork-Presbyterian Hospital· New York, NYUniversity of Wisconsin Carbone Cancer Center· Madison, WI

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