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Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma Study

ConditionMelanoma Metastatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliera di Perugia

About this trial

The association between microbiota and response to ICI-based therapy reflects the ability of bacterial metabolites to upregulate MHC class I APM component expression and/or function in cancer cells, leading to their elimination by the host's immune system.

Thus, the aim of this project is to evaluate the ability of anti PD-1 combined with postbiotic, that here will be a coadjuvant of a standard immunotherapy to upregulate MHC class I APM component expression and/or function in cancer cells compared to anti PD-1 alone in first line advanced melanoma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years or older

Histologically confirmed, unresectable stage IIIC or IV metastatic melanoma;

Eastern Cooperative Oncology Group performance status of 0 or 1;

The patient must treatment naïve for metastatic disease

Disqualifiers

Patients with mucosal or with a primary ocular melanoma

Active symptomatic or asymptomatic brain metastases

Patients with the following disorders: active, known, or suspected autoimmune disease (except for some non-serious disorders, such as vitiligo and type 1 diabetes mellitus, as specified in the study protocol);

Previous malignancies (exceptions skin basocellular or squamocellular carcinoma radically resected, in situ uterine cervix in situ carcinoma radically resected) in the previous 2 years.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Postbiotic

    Dietary supplement

    postbiotic food supplement PostbiotiX-HLA 1 capsule (200mg) /day

  • AntiPD1

    Drug

    Antibody to PD1 approved for standard of care

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Postbiotic+AntiPD1Experimental treatment 2 interventions
Group B: AntiPD1Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Biological response rate

proportion of responder patients at 12 weeks from treatment start. The response to treatment is based on the IHC level of HLA and NRLC5 at baseline and after 12 weeks from treatment start. An IHC level equal to 0 or 1+ is defined as low, while a IHC value equal to 2+ or 3+ is defined as high

Time frame
18 months

Secondary outcomes

1

Objective Response Rate

the proportion of patients with a complete (CR) or partial response (PR) as best response during treatment as determined by RECIST 1.1.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliera di Perugia

Lead sponsor

Istituto Clinico Humanitas

Collaborator

Source ClinicalTrials.gov
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