Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer (iPRRT)
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ClinicalTrials.gov Identifier: NCT05583708 |
Recruitment Status :
Recruiting
First Posted : October 18, 2022
Last Update Posted : April 17, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | October 12, 2022 | ||||||||
First Posted Date ICMJE | October 18, 2022 | ||||||||
Last Update Posted Date | April 17, 2024 | ||||||||
Actual Study Start Date ICMJE | August 3, 2023 | ||||||||
Estimated Primary Completion Date | September 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate (ORR) [ Time Frame: 2 years ] The objective response rate is the proportion of all subjects with confirmed Partial Response (PR) or Complete Response (CR) according to RECIST 1.1.
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Original Primary Outcome Measures ICMJE |
Objective Response Rate (ORR) [ Time Frame: 2 years ] The objective response rate is the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer | ||||||||
Official Title ICMJE | A Single Arm Study With Safety Run-in of Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Immunotherapy for Patients With Merkel Cell Cancer (HCRN MCC20-443; iPRRT Study) | ||||||||
Brief Summary | 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. | ||||||||
Detailed Description | The study design will be a single arm phase 2 study in patients who have progressed on immunotherapy and who are candidates to continue pembrolizumab. Prior to enrollment in the Phase II portion, a run-in study will be performed to ensure safety and tolerability of the combination of pembrolizumab and lutetium Lu 177 dotatate. Peptide receptor radionuclide therapy (PRRT) will be given every 2 months for 4 doses. Pembrolizumab will be given every 6 weeks at 400mg fixed dosing for up to 2 years, until disease progression, or unacceptable toxicity. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Merkel Cell Carcinoma | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | 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) Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
18 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 2026 | ||||||||
Estimated Primary Completion Date | September 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Subjects meeting any of the criteria below may not participate in the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05583708 | ||||||||
Other Study ID Numbers ICMJE | 22-10025228 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Weill Medical College of Cornell University | ||||||||
Original Responsible Party | Pashtoon M. Kasi, Hoosier Cancer Research Network, Sponsor-Investigator | ||||||||
Current Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||||||
Original Study Sponsor ICMJE | Pashtoon M. Kasi | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Weill Medical College of Cornell University | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |