Immunotherapy drug aims to stop deadly skin cancer's return in high-risk patients
NCT ID NCT03271372
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether the immunotherapy drug avelumab can keep Merkel cell carcinoma from returning in patients whose cancer has spread to lymph nodes and who have already had surgery or radiation. About 100 adults will receive either avelumab or a placebo every two weeks for up to a year. The goal is to see if avelumab helps the immune system attack any remaining cancer cells and improves survival without the cancer coming back.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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101 people
The number who actually took part.
- Started
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Dec 2017
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed MCC metastases in regional lymph node(s) * Confirmation of the MCC diagnosis in the regional lymph node(s) is mandatory for trial participation * (NOTE: In-transit metastases without regional nodal involvement could be allowed, but only after written approval of the medical monitor) * Must have completed definitive treatment for primary MCC and regional lymphatic metastases that included surgical removal (with/without adjuvant radiation therapy) or primary radiation therapy as determined by the treating investigator * Aged \>= 18 years. Both men and women, and members of all races and ethnic groups are eligible for this trial. * Estimated life expectancy greater than 3 years * Must start the study treatment no more than 120 days from the start date of definitive therapy (the date of surgical removal of nodal metastases or the date of initiation of definitive radiation therapy, as applicable) * Eastern Co-Operative Group (Eastern Cooperative Oncology Group \[ECOG\]) performance score of 0 or 1 * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 9 g/dL (may have been transfused) * Total bilirubin level ≤ 1.5 x the upper limit of normal (ULN) range * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x ULN * Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula or by 24-hour urine collection for creatinine clearance or according to local institutional standard * Women of childbearing potential must have a negative serum or urine pregnancy test at screening * Both male and female subjects must be willing to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists \* (NOTE: The effects of the study treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, as stipulated in national or local guidelines. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately.) * Must have an ability to understand and the willingness to sign a written informed consent document * Must consent to allow the acquisition of existing formalin-fixed paraffin-embedded (FFPE) tumor tissue, either a block or unstained slides, for performance of correlative studies Exclusion Criteria: * Clinical or radiologic suspicion of residual MCC at the time of enrollment * Suspicion or known history of distant metastatic MCC, which is not classifiable as local recurrence or regional metastasis * Any prior systemic therapy (e.g. adjuvant, neo-adjuvant or concurrent use of chemotherapy, immunotherapy or an investigational agent) for MCC at any time * Any prior intra-lesional MCC therapy within 180 days from day 1 of study treatment * Residual toxicity from prior therapy grade \> 1 (National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[NCI-CTCAE v 5.0\]) that could interfere with study endpoints or put patient safety at risk * Previous malignant disease (other than Merkel cell carcinoma) diagnosed within 3 years from day 1 of study treatment that could interfere with study endpoints or put patient safety at risk \* (NOTE: Exception will be made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ \[skin, bladder, cervical, colorectal, breast\] or low grade prostatic intraepithelial neoplasia or Grade 1 prostate cancer; any other neoplasm, which is adjudged by the treating investigator to have a low risk of recurrence during the study, could be enrolled only after written approval from the medical monitor) * Use of any systemic immunosuppressive treatments including corticosteroids, cyclosporine, mycophenolate mofetil et cetera, ongoing or within the last 3 months prior to day 1 of treatment \* (NOTE: Patients on physiologic dose of corticosteroids \[≤ 10 mg/day of prednisone or equivalent\] for long-term hormone-replacement therapy or those requiring short, intermittent courses of corticosteroids for hypersensitivity prophylaxis \[such as for iodinated computed tomography (CT) contrast prophylaxis\] or those using intranasal, inhaled, topical steroids, or local steroid injection \[e.g., intra-articular injection\] can be allowed) * Immunosuppressed status due to known human immunodeficiency virus (HIV) infection, severe uncontrolled diabetes, concurrent hematological malignancy, or other comorbidities * Uncontrolled intercurrent illness including, but not limited to, active serious infection, active hepatitis B or hepatitis C infection, uncontrolled seizure disorder, substance abuse disorder, or psychiatric illness/social situations that would limit compliance with study requirements or would put the patient at increased risk of complications during the study period * Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication * Active or history of any serious autoimmune disease, prior organ transplantation, including allogeneic stem-cell transplantation or immune-deficiencies that required treatment with systemic immunosuppressive drugs and could flare-up during study treatment \* (NOTE: Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible) * Other severe acute or chronic medical conditions including immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study * Known prior severe hypersensitivity to investigational product or any component in its formulations that could interfere with study endpoints or put patient safety at risk * Pregnant or breast-feeding women
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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University of California Irvine Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
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University of Colorado Cancer Center University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
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University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States