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Phase 2 Study of Pembrolizumab and Lutetium Lu 177 Dotatate for Merkel Cell Cancer

This study is testing a combination of two drugs, pembrolizumab and lutetium Lu 177 dotatate (Lutathera®), for patients with Merkel cell carcinoma. Pembrolizumab is an immunotherapy that helps your immune system fight cancer. Lutathera is a radioactive drug that kills cancer cells. Pembrolizumab is already approved for Merkel cell cancer, while Lutathera is approved for other types of cancer but not yet for Merkel cell cancer. The study aims to see how well this combination works together. You may be able to join if you are 18 or older, have Merkel cell carcinoma that has progressed on immunotherapy, and are able to continue pembrolizumab. The main goal is to see how many patients respond to the treatment over two years. The current recruitment status is unclear.

Study design
This is a single-arm Phase 2 study, meaning all 18 planned participants will receive the same treatment. A small initial study will ensure the safety of the drug combination.
What's involved
You would receive pembrolizumab every 6 weeks for up to two years, or until your disease gets worse or side effects become too much. Lutetium Lu 177 dotatate will be given every 2 months for a total of 4 doses.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 2 years, which suggests follow-up will occur for at least this long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05583708

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Weill Medical College of Cornell University
~18 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:PembrolizumabLutetium Lu 177 dotatate

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over 2 years

Conditions

Merkel Cell Carcinoma

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Where it's being run

3 sites across 3 states
Iowa1
New York1
Wisconsin1

Study leadership

  • Anna C Pavlick, BSN, MSc, DO, MBA · PRINCIPAL_INVESTIGATOR · Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine

Who to contact

Anna C Pavlick, BSN, MSc, DO, MBA
[email protected]
646.962.
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has received at least 2 doses of an approved anti-PD-1/L1 mAb
Has demonstrated disease progression after anti-PD-1/L1 as defined by RECIST v1.1.
Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb. Note: This determination is made by the local investigator. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression. 7. Prior cancer treatment must be completed and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline. 8. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration.
Hematological:
Absolute Neutrophil Count (ANC): ≥ 1500/uL
Platelets: ≥100,000/uL
Hemoglobin (Hgb): ≥9.0g/dL or ≥5.6mmol/L
Renal:
Creatinine: 1.5 x ULN OR
Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≥30mL/min for participant with creatinine levels \>1.5 x institutional ULN
Hepatic:
Total bilirubin: ≤1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 x ULN
AST(SGOT) and ALT(SGPT): ≤2.5 x ULN (≤5 x ULN for participants with liver metastases)
Coagulation:
International normalized ratio (INR) OR prothrombin time (PT): ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT): ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants 9. Females of childbearing potential who are sexually active with a male able to father a child must have a negative serum pregnancy test within 7 days prior to registration. 10. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from the time of informed consent, during the study and for 7 months after the last dose of study drug(s). Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from initiation of treatment, during the study and for 120 days after the last dose of study drug(s). 11. Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration.
Known history of HBV infection
As mandated by local health authority 12. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
Known history of HCV infection
As mandated by local health authority 13. HIV-infected participants must have well-controlled HIV on anti-retroviral therapy (ART), defined as:

What this trial measures

  • Objective Response Rate (ORR)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.