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Merkel Cell CarcinomaPhase 2MERCURYNCT05594290

Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery

A Phase 2 study testing Retifanlimab, Cisplatin and Etoposide in people with Merkel Cell Carcinoma, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a window-of-opportunity study for patients with resectable Merkel Cell Carcinoma. The aim of this study is to test the activity of a course of chemo-immunotherapy followed by surgery in patients with operable Merkel cell carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Merkel Cell Carcinoma
What is being tested?
Retifanlimab, Cisplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteItaly
Study dates
7 Dec 2022to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • Subjects must be 18 years old or older.
  • ECOG performance status of 0 to 1.
  • Histologically confirmed diagnosis of MCC amenable for radical surgery as defined by local or institutional surgical practices, based on multidisciplinary team assessment. Subjects must have one of the following stages of disease:
  • Stage IIA - IIB- III (according to the AJCC staging system 8th edition)
  • Local/Regional recurrent disease after primary surgery, as defined as total disease burden ≥ 1 cm diameter amenable for a radical intent surgery. Note: nodal disease without any known primary (in absence of a primary cutaneous site after a complete diagnostic/staging work-up including chest/abdomen CT-scan, dermatologic clinical examination and 18F-FDG-PET scan) can be enrolled and will be considered as Stage III.
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  • Able to provide archival FFPE tumor samples (if collected within three months from study enrollment) or have a tumor amenable to pre-treatment biopsy. Excisional, incisional, or core- needle samples are acceptable. Fine needle aspirates are not allowed.
  • No prior systemic treatment or neoadjuvant radiation therapy.
  • Adequate bone marrow function characterized by the following at screening:
  • Platelets ≥ 100 × 109/L
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Hemoglobin ≥ 9.0 g/dL
  • Adequate renal function characterized by serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 60 mL/min at screening for subject receiving cisplatin OR creatinine clearance ≥ 50 mL/min at screening for subject receiving carboplatin.
  • Adequate hepatic function characterized by the following at screening:
  • Serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL. Note: Subjects with Serum total bilirubin ≥ 1.5 × ULN and conjugated bilirubin ≤ ULN or < 40% of total bilirubin are allowed.
  • AST (SGOT) and/or ALT (SGPT) <2.5 x UNL.
  • Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 6 months after the administration of study treatment and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed.
  • Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through 180 days after the administration of any study drug. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
  • Women of non-childbearing potential (i.e. surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible.
  • Willingness to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Who cannot join

  • Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or PD-L1-directed therapy.
  • Primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine.
  • Treatment with anticancer drugs, radiation therapy or participation in another interventional clinical study within 28 days before the first administration of study drug.
  • Distant metastases at any site.
  • Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry except for cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
  • Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
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  • History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft [CABG], coronary angioplasty or stenting) ≤ 6 months prior to start of study treatment;
  • Symptomatic congestive heart failure (i.e., Grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality ≤ 6 months prior to start of study treatment, except atrial fibrillation and paroxysmal supraventricular tachycardia
  • History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
  • Note: Subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Subjects with controlled type I diabetes mellitus on a stable insulin regimen, vitiligo or psoriasis not requiring systemic treatment may be eligible.
  • History of chronic conditions (i.e. COPD) requiring systemic immune-suppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
  • Evidence of interstitial lung disease or active noninfectious pneumonitis.
  • History of organ transplant, including allogeneic stem cell transplantation.
  • History or current evidence of any condition, therapy or laboratory abnormality that might interfere with the subject's participation to the study or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Know active hepatitis B [positive HBV surface antigen (HBsAg) result] or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Known uncontrolled HIV infection. HIV-positive patients are eligible if their CD4+ cell count amounts to 300 cells per μL or more; HIV viral load must be undetectable per standard of care assay, and they have to be compliant with antiretroviral treatment.
  • Active infections requiring systemic therapy, or systemic antibiotic use up to 10 days before Cycle 1 Day 1.
  • Live vaccines within 28 days prior to and for a duration of 90 days after the administration of study drug are forbidden.
  • Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chickenpox/zoster, yellow fever, rabies, Bacillus Calmette Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. COVID-19 vaccine is allowed, with an interval of 2 days before and 2 days after the administration of study drugs;
  • Known hypersensitivity to platinum, etoposide or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids).
  • Known allergy or hypersensitivity to any component of the study drug formulation.
  • Subjects who lack the ability or are unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
  • Subjects who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    Milan, 20133

Other trials in Italy

About this study

Official title: Window-of-opportunity Study of Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery: the MERCURY Trial

This is a window-of-opportunity study for patients with resectable Merkel Cell Carcinoma.

The aim of this study is to test the activity of a course of chemo-immunotherapy followed by surgery in patients with operable Merkel cell carcinoma.

Participants will receive one cycle of retifanlimab plus platinum-etoposide chemotherapy prior to their scheduled surgery.

Read the detailed description

This is a multicenter, single-arm, open-label, phase 2 Window-of-opportunity trial to assess the activity of 1 cycle of preoperative retifanlimab plus platinum-etoposide chemo-immunotherapy regimen in patients with resectable MCC (stage IIA-III).

Patients who meet the eligibility criteria will be treated with one cycle of chemo-immunotherapy.

After receiving the short-course preoperative chemo-immunotherapy study regimen, patients will undergo standard radical surgery between weeks 5 and 6 from enrollment. After surgery, patients will receive adjuvant radiation therapy, if indicated, and afterwards, standard follow up will be started as per clinical practice and guidelines.

Baseline radiological assessments will include chest/abdomen/pelvis CT scan with contrast and CT scan of additional anatomical sites should be performed if the primary tumor is elsewhere.

The enrollment of patients will be temporary interrupted after the inclusion of first 6 patients in the trial. When 6 patients will complete the study treatment, a Safety Monitoring Committee will complete a safety evaluation.

The enrollment will then resume only if the study treatment combination is judged feasible and no major safety concerns arise.

The study primary endpoint will be the pathological complete response rate or pCR rate, defined as the percentage of patients, relative to the total of enrolled subjects in the intention-to-treat population, who will achieve a pathological complete response, as per central pathological review.

Being tested
Retifanlimab, Cisplatin, Etoposide
Keywords
Merkel Cell Carcinoma, Chemo-immunotherapy, Retifanlimab, Surgery
Medical subject headings
Carcinoma, Merkel Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetifanlimabDrug

    Retifanlimab i.v. 500 mg day 1

  • CisplatinDrug

    Cisplatin 25 mg/sqm i.v. day 1, 2 (recommended platinum agent) or carboplatin AUC 4 i.v., day 1 (in patients unsuited or unfit for cisplatin)

  • EtoposideDrug

    Etoposide 100 mg/sqm iv. day 1, 2, 3

Study groups in NCT05594290
Study groupRoleWhat they receive
Preoperative armExperimentalPatients will be treated with one cycle of chemo-immunotherapy with retifanlimab (500 mg day 1), cisplatin (25 mg/sqm i.v. day 1, 2 ) or carboplatin (AUC 4 i.v., day 1 - in patients unsuited or unfit for cisplatin) and etoposide (100 mg/sqm iv. day 1, 2, 3). After receiving the short-course preoperative chemo-immunotherapy study regimen, patients will undergo standard radical surgery. After surgery, patients will receive adjuvant radiation therapy if indicated
Receives: Drug: Retifanlimab; Drug: Cisplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate (pCR rate)

    Percentage of patients, relative to the total of enrolled subjects in the intention-to-treat population, who will achieve a pathological complete response, as per central pathological review. Pathological complete response will be defined as the absence of residual viable invasive cancer on evaluation of the complete resected tumor specimen and all sampled regional lymph nodes.

    Measured: 5 weeks

Secondary outcomes (9)

  1. Safety of the preoperative chemo-immunotherapy study regimen

    Incidence of adverse events (AEs)

    Measured: 5 weeks

  2. Safety of the preoperative chemo-immunotherapy study regimen

    Incidence of serious adverse events (SAEs)

    Measured: 5 weeks

  3. Safety of the preoperative chemo-immunotherapy study regimen a

    G3/4 Toxicity Rate defined as the percentage of patients, relative to the total of enrolled subjects, experiencing any specific adverse event of grade 3/4, according to NCI-CTCAE v5.0, during the short-course preoperative chemo-immunotherapy study regimen

    Measured: 5 weeks

  4. Safety of the preoperative chemo-immunotherapy study regimen a

    Rate of surgery delay, defined as the proportion of patients receiving the short- course preoperative chemo-immunotherapy study regimen with surgery delayed > 4 weeks from the planned date due to a drug-related AE

    Measured: 5 weeks

  5. Safety of the preoperative chemo-immunotherapy study regimen a

    Surgical mortality

    Measured: 5 weeks

  6. Patients' quality of life

    Quality of life will be assessed through Patient reported outcomes (PRO) instrument: FACT-M Questionnaire

    Measured: 5 weeks

  7. Impact of the short-course preoperative chemo-immunotherapy study regimen on patients' quality of life

    Quality of life will be assessed through Patient reported outcomes (PRO) instrument: EQ-5D-5L

    Measured: 5 weeks

  8. Relapse Free Survival

    Relapse Free Survival will be defined as the time from enrollment to the first documentation of disease recurrence or death due to any cause, whichever occurs first.

    Measured: 24 months

  9. Overall Survival

    Overall survival will be defined as the time from enrollment to the date of death due to any cause.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2022
  2. Study start7 Dec 2022
  3. Primary completion15 Nov 2025
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase 2, multicentre, single-arm, open-label clinical trial
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05594290
Sponsor's protocol ID
MERCURY
Acronym
MERCURY
Status last verified
Jan 2026
First submitted
17 Oct 2022
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The trial results concerning the primary, secondary and exploratory outcomes will be published according to the standard guidelines. IPD could eventually be requested to the Sponsor and Principal Investigator, who will carefully evaluate the formal and motivated request.

Publications

  • Fields RC, Busam KJ, Chou JF, Panageas KS, Pulitzer MP, Allen PJ, Kraus DH, Brady MS, Coit DG. Recurrence after complete resection and selective use of adjuvant therapy for stage I through III Merkel cell carcinoma. Cancer. 2012 Jul 1;118(13):3311-20. doi: 10.1002/cncr.26626. Epub 2011 Nov 9.

    PubMed 22072529

  • D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbe C, Lewis KD, Linette GP, Milella M, Georges S, Shah P, Ellers-Lenz B, Bajars M, Guzel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer. 2020 May;8(1):e000674. doi: 10.1136/jitc-2020-000674.

    PubMed 32414862

  • Hodgson NC. Merkel cell carcinoma: changing incidence trends. J Surg Oncol. 2005 Jan 1;89(1):1-4. doi: 10.1002/jso.20167.

    PubMed 15611998

  • Heath M, Jaimes N, Lemos B, Mostaghimi A, Wang LC, Penas PF, Nghiem P. Clinical characteristics of Merkel cell carcinoma at diagnosis in 195 patients: the AEIOU features. J Am Acad Dermatol. 2008 Mar;58(3):375-81. doi: 10.1016/j.jaad.2007.11.020.

    PubMed 18280333

  • Harms KL, Healy MA, Nghiem P, Sober AJ, Johnson TM, Bichakjian CK, Wong SL. Analysis of Prognostic Factors from 9387 Merkel Cell Carcinoma Cases Forms the Basis for the New 8th Edition AJCC Staging System. Ann Surg Oncol. 2016 Oct;23(11):3564-3571. doi: 10.1245/s10434-016-5266-4. Epub 2016 May 19.

    PubMed 27198511

  • Becker JC. Merkel cell carcinoma. Ann Oncol. 2010 Oct;21 Suppl 7:vii81-5. doi: 10.1093/annonc/mdq366.

    PubMed 20943647

  • Chalabi M, Fanchi LF, Dijkstra KK, Van den Berg JG, Aalbers AG, Sikorska K, Lopez-Yurda M, Grootscholten C, Beets GL, Snaebjornsson P, Maas M, Mertz M, Veninga V, Bounova G, Broeks A, Beets-Tan RG, de Wijkerslooth TR, van Lent AU, Marsman HA, Nuijten E, Kok NF, Kuiper M, Verbeek WH, Kok M, Van Leerdam ME, Schumacher TN, Voest EE, Haanen JB. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med. 2020 Apr;26(4):566-576. doi: 10.1038/s41591-020-0805-8. Epub 2020 Apr 6.

    PubMed 32251400

  • Topalian SL, Bhatia S, Amin A, Kudchadkar RR, Sharfman WH, Lebbe C, Delord JP, Dunn LA, Shinohara MM, Kulikauskas R, Chung CH, Martens UM, Ferris RL, Stein JE, Engle EL, Devriese LA, Lao CD, Gu J, Li B, Chen T, Barrows A, Horvath A, Taube JM, Nghiem P. Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial. J Clin Oncol. 2020 Aug 1;38(22):2476-2487. doi: 10.1200/JCO.20.00201. Epub 2020 Apr 23.

    PubMed 32324435

  • Gotwals P, Cameron S, Cipolletta D, Cremasco V, Crystal A, Hewes B, Mueller B, Quaratino S, Sabatos-Peyton C, Petruzzelli L, Engelman JA, Dranoff G. Prospects for combining targeted and conventional cancer therapy with immunotherapy. Nat Rev Cancer. 2017 May;17(5):286-301. doi: 10.1038/nrc.2017.17. Epub 2017 Mar 24.

    PubMed 28338065

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retifanlimab, Cisplatin and Etoposide in people with Merkel Cell Carcinoma, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (pCR rate) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05594290, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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