Actively Recruiting
Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients
Led by Philogen S.p.A. · Updated on 2024-10-26
162
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
P
Philogen S.p.A.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.
CONDITIONS
Official Title
Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be 18 years of age or older
- Have confirmed unresectable metastatic melanoma at stage III B, C, D or IV M1a, including certain oligometastatic disease up to 10 lesions
- Have confirmed primary or acquired resistance to anti-PD1/L1 monoclonal antibody therapy
- If BRAF mutated, have received BRAF/MEK inhibitors and then anti-PD1 therapy with resistance
- Have measurable disease and at least one injectable melanoma lesion 5 mm or larger
- Female participants must not be pregnant or breastfeeding and follow contraceptive guidance if of childbearing potential
- Provide archival or new tumor tissue sample for testing
- Have ECOG performance status 0 or 1
- Have adequate organ function within 14 days before treatment
- Able to provide biopsy samples for biomarker analysis
- Negative tests for HIV, HBV, and HCV
- All acute toxic effects from prior therapies resolved to grade 1 or baseline, with some exceptions
- Full resolution of checkpoint inhibitor-related adverse effects and no treatment for these effects for at least 4 weeks prior
- No history of severe immune-related adverse effects from prior checkpoint therapy
- Male participants with partners of childbearing potential must agree to use two contraception methods and avoid sperm donation
- Willing and able to comply with study procedures
You will not qualify if you...
- Have more than 10 distant melanoma lesions combined in lung, liver, bone, or brain
- Have symptomatic or rapidly enlarging/bleeding brain lesions
- Have uveal, mucosal, or unknown primary melanoma
- Female participants of childbearing potential with positive pregnancy test
- Prior treatment discontinued due to severe immune-related adverse effects
- Received systemic anti-cancer therapy or investigational agents within 4 weeks before study treatment
- Received radiotherapy within 2 weeks before study treatment or history of radiation pneumonitis
- Undergone allogeneic stem cell transplant within 5 years or had allogeneic organ transplant
- Received live or live attenuated vaccines within 30 days before treatment
- Have immunodeficiency or receiving high-dose systemic steroids or immunosuppressive therapy within 7 days before treatment
- Have another progressing malignancy requiring active treatment within past 2 years
- Have active central nervous system metastases or carcinomatous meningitis unless stable and off steroids
- Have severe hypersensitivity to pembrolizumab, IL2, TNF, or their excipients
- Have active autoimmune disease requiring systemic treatment in past 2 years
- Have history or current pneumonitis or interstitial lung disease requiring steroids
- Have active infection requiring systemic therapy
- Conditions or factors interfering with study participation or safety as judged by investigator
- Known psychiatric or substance abuse disorders affecting cooperation
- Previously enrolled in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
G
Giuliano Elia, PhD
CONTACT
M
Marco Taras
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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