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New treatment option for Merkel Cell Carcinoma
Official title Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer
ClinicalTrials.gov ID: NCT05583708
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for merkel cell carcinoma.
Also referred to as Keytruda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be...
- Male and female, age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration.
- Histological or cytological evidence of Merkel cell cancer per AJCC, 8th edition.
- Presence of somatostatin receptors by Ga-68 dotatate (or equivalent) imaging, which is a requirement for PRRT (lutetium Lu 177 dotatate...
You likely can't join if
- people meeting any of the criteria below may not participate in the study:
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell...
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they...
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
- Has had an allogeneic tissue/solid organ transplant.
See the full eligibility criteria
Who can join
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Male and female, age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration.
- Histological or cytological evidence of Merkel cell cancer per AJCC, 8th edition.
- Presence of somatostatin receptors by Ga-68 dotatate (or equivalent) imaging, which is a requirement for PRRT (lutetium Lu 177 dotatate [Lutathera®]). Must have at least one measurable lesion per RECIST 1.1.
- 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...
- 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...
- 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.
- 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
- 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.
- 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...
- 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. Note: Participants should remain on...
- Known history of HBV infection
- As mandated by local health authority
- Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization...
- Known history of HCV infection
- As mandated by local health authority
- HIV-infected participants must have well-controlled HIV on anti-retroviral therapy (ART), defined as:
- Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
- Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of...
- It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
- Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study NOTE: HIV-infected...
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
What rules you out
- people meeting any of the criteria below may not participate in the study:
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma...
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at...
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to...
- Has had an allogeneic tissue/solid organ transplant.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has active TB (Bacillus Tuberculosis) infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 7 months (females) or 120 days (males) after the last dose...
- Clinically significant cardiovascular disease or cardiac insufficiency (New York Heart Association classes III-IV), cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3...
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- New York, New York, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; New York, New York, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.