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Phase 2 study for Advanced PD-1 refractory melanoma

PVSRIPO with and without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Donaldson, Karin M

    Trial Phone: 321.841.7303 ; 321.841.9821

  • IRB No: W21.026.02

    Protocol Abbrev: LUMINOS-102

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: LUMINOS-102

    Treatment: PVSRIPO is a modified version of the serotype 1 live-attenuated (Sabin) PV vaccine (PV1S) and is classified as an oncolytic viral immunotherapeutic

    Therapies Involved: Oncology: 2nd line

    ClinicalTrials.gov ID: NCT04577807

  • Objective

    1. To evaluate the antitumor activity of PVSRIPO with and without anti-PD-1, in patients who have failed anti-PD-1 therapy

    2. To evaluate the safety/tolerability of PVSRIPO with and without anti-PD-1 therapy

  • Key Eligibility

    1. ≥ 18 years of age
    2. Prior CDC-recommended vaccination series against poliovirus (PV), and has received a boost immunization with PV Inactivated (IPOL®; Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to Day 1 a. Note: Patients who are unsure of their vaccination status must provide evidence of anti-PV immunity prior to enrollment, as applicable
    3. Biopsy proven (within 4 months of Day 1) unresectable melanoma
    a. Note: Ocular melanoma is excluded
    4. Has ≥ 2 melanoma lesions that are accurately measurable by caliper or a radiological method according to RECIST 1.1 criteria.
    a. One lesion must be injectable--defined as a visible or palpable cutaneous, subcutaneous or nodal melanoma lesion ≥ 10mm in longest diameter or multiple injectable melanoma lesions which in aggregate have a longest diameter of ≥ 10mm and where the minimal lesion size is ≥ 5mm.

    b. Note that visceral lesions (eg liver, lung, retroperitoneal, subpleural lesions) are not considered injectable for the purposes of this trial.
    5. Has confirmed disease progression per iRECIST after receiving at least 6 weeks of treatment with an FDA-approved anti-PD-1/anti-PD-L1 therapy (as monotherapy or in combination), without experiencing a toxicity requiring permanent discontinuation of the anti-PD-1/anti-PD-L1. Patients treated with anti-PD-1 in the adjuvant setting and who have confirmed progression after at least 6 weeks of anti-PD-1 therapy are allowed
    a. NOTE: Patients with known BRAF mutation must have also failed or refused to receive BRAF-targeted therapy (alone or in combination with MEK inhibitor) to be eligible
    6. Eastern Cooperative Oncology Group (ECOG) status of 0-1
    7. Serum lactate dehydrogenase (LDH) levels ≤ 3 x upper limit of normal (ULN)
    8. Adequate bone marrow, liver and renal function as assessed by the following:
    a. Hemoglobin ≥9.0 g/dl, patients may be transfused
    b. Lymphocyte count ≥0.5 x 109/L (500 μL)
    c. Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500 μL)
    d. Platelet count ≥ 100 x 109/L (100,000 μL) without transfusion
    e. AST, ALT, and alkaline phosphatase (ALP) ≤2.5 x upper limit of
    normal (ULN), with the following exceptions:
    i. Patients with documented liver metastases: AST and ALT ≤5 x
    ULN
    ii. Patients with documented liver or bone metastases: ALP ≤5 x ULN
    f. Serum bilirubin ≤1.5 x ULN with the following exception:
    i. Patients with known Gilbert disease: serum bilirubin level ≤3 x ULN
    g. Estimated creatinine clearance ≥30 ml/min, per MDRD equation
    h. Serum albumin ≥25 g/L (2.5 g/dL)
    i. For patients not receiving therapeutic anticoagulation: INR, PT, PTT (or aPTT) ≤1.5 x ULN
    9. Life expectancy of >12 weeks
    10. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for the study, and is willing/able to participate in the study