MEM-288 + Nivolumab for Non-Small Cell Lung Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot use other anticancer agents while participating in the trial.
What data supports the effectiveness of the treatment MEM-288 + Nivolumab for Non-Small Cell Lung Cancer?
Research shows that MEM-288, an oncolytic virus, can activate the immune system to fight cancer by increasing T-cell responses and reducing tumor size in non-small cell lung cancer patients. Additionally, combining MEM-288 with checkpoint inhibitors like Nivolumab has shown promise in controlling distant tumors and lung metastases.12345
Is the combination of MEM-288 and Nivolumab safe for humans?
What makes the MEM-288 + Nivolumab treatment unique for non-small cell lung cancer?
MEM-288 is an oncolytic virus (a virus that infects and kills cancer cells) engineered to express interferon beta and CD40 ligand, which can enhance the immune response against cancer. This makes it different from standard treatments like nivolumab alone, which is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.89101112
What is the purpose of this trial?
This is a multipart, open-label, multi-center dose escalation, dose expansion phase I clinical trial designed to evaluate the safety, tolerability, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and preliminary efficacy of MEM-288 in patients with advanced solid tumors. Eligible subjects must have a tumor lesion(s) which is accessible for injection.The dose escalation phase (Part 1A - advanced solid tumors) has completed and is closed to enrollment. This phase evaluated multiple doses of MEM-288 dosed via intratumoral injection once every 3 weeks to assess safety, tolerability, preliminary efficacy, and to determine the MTD.The dose expansion phase has multiple parts for advanced NSCLC. Part 1B has completed after evaluation of MEM-288 dosed via intratumoral injection in combination with standard of care nivolumab dosed via intravenous injection.In a separate dose expansion arm (Part 1C) that is open for enrollment, patients with advanced NSCLC will be randomized to receive either an initial priming dose of MEM-288 injected into an accessible lesion (s) alone (Day 1) followed by MEM-288 in combination with standard of care docetaxel every 3 weeks up to 6 doses or MEM-288 injected into an accessible lesion(s) in combination with standard of care docetaxel therapy Day 1 and every 3 weeks up to 6 doses.The study rationale is that the oncolytic effect of MEM-288 combined with the presence of CD40L and type 1 IFN in injected tumors will provide a strong signal for DC-mediated T cell activation leading to generation of systemic anti-tumor T cell responses with broad specificity akin to what is observed in the abscopal effect.
Research Team
Andreas Saltos, MD
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Neal Ready, MD, PhD
Principal Investigator
Duke Cancer Institute
Eligibility Criteria
Adults over 18 with certain advanced cancers (like NSCLC, melanoma, and pancreatic cancer) who've already tried standard treatments including chemotherapy. They must have a tumor that can be injected and not be pregnant or breastfeeding. People with serious medical issues, active infections, or recent major surgery aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Monotherapy Treatment
Dose escalation trial of MEM-288 monotherapy to determine the maximum tolerated dose and recommended phase II dose
Combination Treatment
Expansion arm testing MEM-288 with concurrent anti-PD-1 (nivolumab) therapy for patients with advanced/metastatic NSCLC
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- MEM-288
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memgen, Inc.
Lead Sponsor
Duke Cancer Institute
Collaborator
H. Lee Moffitt Cancer Center and Research Institute
Collaborator