OncoMatch/Clinical Trials/NCT05583708
Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer
Is NCT05583708 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Lutetium Lu 177 dotatate for merkel cell carcinoma.
Treatment: Pembrolizumab · Lutetium Lu 177 dotatate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
Must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria: 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.
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC): ≥ 1500/uL; Platelets: ≥100,000/uL; Hemoglobin (Hgb): ≥9.0g/dL or ≥5.6mmol/L
Kidney function
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
Liver function
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)
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Iowa Hospitals and Clinics · Iowa City, Iowa
- Weill Cornell Medicine/NewYork-Presbyterian Hospital · New York, New York
- University of Wisconsin Carbone Cancer Center · Madison, Wisconsin
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