Clinical Trial 21399

• Overview

  Study Title:

  Phase I Study of MEM-288 Oncolytic Virus in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

  Summary:

  The purpose of this study is to test the safety and tolerability of intratumoral administration of MEM-288 in participants with NSCLC.

  Objective:

  Primary Objectives: 1. To determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of MEM-288 as a single agent. Secondary Objectives: 1. To assess efficacy overall response rate in a variety of solid tumors, as well as disease control rate, progression free survival and duration of response. 2. To evaluate anti-tumor immune responses of intratumoral MEM-288 single agent by evaluating biopsy tissue of injected lesions and serial blood draws.

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  BMS-936558 (Nivolumab); MEM-288 (); Nivolumab (Opdivo); Pembrolizumab (Keytruda)

• Inclusion Criteria

  Inclusion Criteria:
  • Ability to understand and provide informed consent.
  • Willingness and ability to comply with scheduled study visits and procedures.
  • Adult men or women over 18 years of age
  • ECOG performance status of 0 or 1.
  • Advanced/metastatic NSCLC patients only at Moffitt. cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer at other sites.
  • Per each tumor type, the specific initial standard of care therapies after which the patients with specific histologies must have progressed have been included. Patients will have been treated with at least one or more than one line of therapy prior to enrollment in the study.
  • Non-small cell lung cancer (NSCLC) - Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential). Patients with tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy, and platinum-based chemotherapy.
  • Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer and TNBC.
  • Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).
  • Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor.
  • Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance by an interventional radiologist, and patient willing and able to provide tissue from biopsy of this lesion. Injected tumor should be > 1 cm3 in volume and should not encase or be inseparable from vital structures such as major nerves or blood vessels. For patients treated at the first dose level, the tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion that is palpable.
  • Measurable disease, as defined per RECIST version 1.1.
  • Prior history of brain metastases are eligible, provided: Brain metastases have been treated. Asymptomatic from the brain metastases. Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study. Brain metastases are stable on pre-registration imaging. No evidence of leptomeningeal disease.
  • Life expectancy > 3 months. Additional criteria apply

• Exclusion Criteria

  Exclusion Criteria:
  • Pregnant or breast feeding.
  • Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.
  • Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.
  • History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.
  • Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.
  • Concurrent use of other anticancer approved or investigational agents.
  • Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as: (a) unstable angina within 6 months prior to screening (b) myocardial infarction within 6 months prior to screening (c) history of documented congestive heart failure (New York Heart Association functional classification III-IV) (d) cardiac arrhythmias not controlled with medication
  • Active autoimmune disease requiring disease modifying therapy (except vitiligo, Grave's, or psoriasis not requiring systemic treatment).
  • Any form of active primary or secondary immunodeficiency.
  • Receiving ≥10 mg daily prednisone (or equivalent) within 7 days prior to starting study treatment.
  • Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia endometrial, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period.
  • Active systemic infections requiring intravenous antibiotics.
  • Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents (other than FDA approved and National Comprehensive Cancer Network [NCCN] recommended systemic therapies. Other criteria may apply

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