Actively Recruiting
Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma Study
Led by Azienda Ospedaliera di Perugia · Updated on 2025-07-03
35
Participants Needed
5
Research Sites
78 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera di Perugia
Lead Sponsor
I
Istituto Clinico Humanitas
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Histologically confirmed, unresectable stage IIIC or IV metastatic melanoma
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Treatment na�ve for metastatic disease
- Patients who received anti-PD-1 therapy or anti BRAF/MEK in adjuvant setting and relapsed after 6 months of ending adjuvant therapy
- At least one measurable lesion based on RECIST 1.1
- Willing to undergo pretreatment tumor biopsy or provide qualifying archival tumor tissue
- Recovered from effects of prior systemic anticancer therapies and surgery
- Waited at least 5 half-lives or 4 weeks after prior systemic anti-neoplastic agents
- Estimated life expectancy of at least 3 months
- Adequate hematologic reserve (ANC 1000/bcL, lymphocytes 500/bcL, platelets 75,000/bcL, hemoglobin 9 g/dL)
- Adequate hepatic function (AST/ALT 3 d7 ULN, bilirubin 1.5 d7 ULN; higher limits for Gilbert's syndrome/liver metastasis)
- Adequate renal function (serum creatinine 1.5 d7 ULN or creatinine clearance 45 mL/min)
- INR/PT/aPTT 1.5 d7 ULN or within therapeutic range if on anticoagulants
- Agree to contraceptive requirements
- Negative pregnancy test for women of childbearing potential within 3 days before first dose
- Life expectancy more than 3 months
- Presence of measurable or evaluable lesions
- Informed consent obtained
You will not qualify if you...
- Patients with mucosal or primary ocular melanoma
- Active symptomatic or asymptomatic brain metastases
- Active, known, or suspected autoimmune disease (except some non-serious disorders like vitiligo and type 1 diabetes mellitus)
- Previous malignancies within the past 2 years except certain skin cancers and in situ cervical carcinoma that were radically resected
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Bari University-Oncologia medica
Bari, BA, Italy
Not Yet Recruiting
2
Torino University-Le Molinette
Torino, TO, Italy
Not Yet Recruiting
3
IRCCS Papa Giovanni II Bari
Bari, Italy
Not Yet Recruiting
4
INT Milano
Milan, Italy
Not Yet Recruiting
5
AO Perugia
Perugia, Italy, 06132
Actively Recruiting
Research Team
M
Mario Mandalà, MED
CONTACT
R
Roberta Matocci, Pharmacist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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