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Merkel Cell CarcinomaPhase 2PANDORANCT06086288

Study of PembrolizumAb combiNeD With Cisplatin or carbOplatin and Etoposide in Treatment naïve Advanced meRkel Cell cArcinoma (MCC)

A Phase 2 study testing Pembrolizumab, Etoposide, Cisplatin or Carboplatin in people with Merkel Cell Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 3 sites in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open label, multicenter, phase II study evaluating the activity and safety of pembrolizumab combined with cisplatin/carboplatin and etoposide as first line treatment in patients with advanced MCC. 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?
Pembrolizumab, Etoposide, Cisplatin or Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesItaly
Study dates
Nov 2023to Dec 2027
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

  • Male/female subjects with histologically confirmed diagnosis of MCC, who have not received prior systemic treatment for their advanced or metastatic MCC, are at least 18 years of age on the day of signing informed consent, will be enrolled in this study.
  • Male participants:
  • A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days, corresponding to time needed to eliminate any study treatments (e.g. 5 terminal half-lives for pembrolizumab and/or any active comparator/combination) plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period.
  • Female participants:
  • A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatments (pembrolizumab and/or any active comparator/combination) plus 30 days (a menstruation cycle) after the last dose of study treatment.
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  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Unresectable and locally advanced, relapsed or metastatic MCC stage IIIB-IV according to American Joint Committee on Cancer (AJCC) TNM Staging Classification for Merkel Cell Carcinoma (8th ed. 2017)
  • No prior systemic treatment for metastic MCC. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the onset of metastatic disease.
  • Have a life expectancy of at least 3 months.
  • Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
  • Have adequate organ function (protocol table 4)

Who cannot join

  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Has received prior systemic anti-cancer therapy.
  • Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • 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.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
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  • 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 the first dose of study drug.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • 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 least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection.
  • Has a known history of active Hepatitis B (defined as HBV DNA is detected) or known active Hepatitis C virus (defined as HCV RNA quantitative is detected) 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 participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • 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 120 days after the last dose of trial treatment.
  • Has had an allogenic tissue/solid organ transplant.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Pusceddu contact

+390223903251

sara.pusceddu@istitutotumori.mi.it

Elvira Rostanzo contact

+390223902415

elvira.rostanzo@istitutotumori.mi.it

Italy3 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Sara Pusceddu, MD, +390223903066, sara.pusceddu@istitutotumori.mi.it

    Maria Libera La Porta, +390223903892, maria.laporta@istitutotumori.mi.it

  • AOUS Policlinico Le Scotte

    Siena

    Anna Maria Di Giacomo, annamaria.digiacomo@unisi.it

    Anna Maria Di Giacomo, MD

  • Azienda Ospedaliera Universitaria Integrata (AOUI)

    Verona

    Sara Cingarlini, sara.cingarlini@aovr.veneto.it

    Sara Cingarlini, MD

Other trials in Italy

About this study

Official title: Phase II, Open Label, Single Arm Study of PembrolizumAb combiNeD With Cisplatin or carbOplatin and Etoposide in Treatment naïve Advanced meRkel Cell cArcinoma (MCC) (PANDORA Trial)

This is an open label, multicenter, phase II study evaluating the activity and safety of pembrolizumab combined with cisplatin/carboplatin and etoposide as first line treatment in patients with advanced MCC.

Being tested
Pembrolizumab, Etoposide, Cisplatin or Carboplatin
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.

  • Pembrolizumab, Etoposide, Cisplatin or CarboplatinDrug

    Induction Phase (4 cycles, 1Cycle=3W): Pembrolizumab 200 mg + Etoposide + Cisplatin or Carboplatin; Maintenance Phase (16 Cycles, 1Cycle=6W): Pembrolizumab 400 mg

Study groups in NCT06086288
Study groupRoleWhat they receive
Single ArmExperimentalNot described
Receives: Drug: Pembrolizumab, Etoposide, Cisplatin or Carboplatin

What is being measured

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

  1. To assess the safety and antitumor activity of pembrolizumab combined with cisplatin/carboplatin and etoposide as first line treatment in MCC.

    ORR, that will be defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria

    Measured: 48 months

Secondary outcomes (6)

  1. To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC

    Incidence of Serius Adverse Events (SAE)

    Measured: 48 months

  2. To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC

    Incidence and severity of Adverse Events (AEs) according to NCI Common Terminology criteria Adverse Event (CTCAE), version 5.0

    Measured: 48 months

  3. To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC

    Incidence and severity of Immune-mediated Adverse Events (imAE)

    Measured: 48 months

  4. To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC

    Overall Survival (OS) that will be measured from the date of starting therapy to the date of death by any cause

    Measured: 48 months

  5. To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC

    Progression Free Survival (PFS) that will be measured from the date of starting therapy to the date of disease progression or death.

    Measured: 48 months

  6. To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC

    Duration of Response (DOR) that will be measured from the date of the first response to disease progression or death in those patients who achieved a CR o PR during study treatment.

    Measured: 48 months

Timeline

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

  1. First posted17 Oct 2023
  2. Study startNov 2023 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (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
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06086288
Sponsor's protocol ID
2022-500988-12-00
Acronym
PANDORA
Status last verified
Sep 2023
First submitted
26 Sep 2023
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Oldani S, Prinzi N, Morano F, Cingarlini S, Di Giacomo AM, Niger M, Prisciandaro M, Raimondi A, Randon G, Pircher CC, Borghesani M, Valente M, Rostanzo E, Milione M, Sabella G, Cascella T, Ghelardi F, Sciortino C, Gusmaroli E, Nasca V, de Braud F, Pietrantonio F, Pusceddu S. Design and rationale of the phase II PANDORA trial: first line chemo-immunotherapy in advanced Merkel cell carcinoma. Future Oncol. 2025 Jul;21(17):2127-2133. doi: 10.1080/14796694.2025.2514402. Epub 2025 Jun 12.

    PubMed 40501309

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Etoposide, Cisplatin or Carboplatin in people with Merkel Cell Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 3 sites 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 14 inclusion and 19 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: opening soon, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Contact Sara Pusceddu (+390223903251, sara.pusceddu@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety and antitumor activity of pembrolizumab combined with cisplatin/carboplatin and etoposide as first line treatment in MCC. (time frame: 48 months). 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 NCT06086288, which also lists 1 linked publication.

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 17 Oct 2023.

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