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Virus Therapy
MEM-288 + Nivolumab for Non-Small Cell Lung Cancer
Phase 1
Recruiting
Led By Neal Ready, MD, PhD
Research Sponsored by Memgen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is designed to find the maximum tolerated dose of MEM-288 monotherapy, and to see if the oncolytic effect of MEM-288 can provide a strong signal for dendritic cell-mediated T cell activation, leading to the generation of systemic anti-tumor T cell responses.
Who is the study for?
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.
What is being tested?
The trial is testing MEM-288, an oncolytic virus given by injection directly into the tumor. Initially alone to find the safest dose, then combined with Nivolumab for those whose lung cancer worsened after standard treatment. The goal is to boost the body's immune response against cancer.
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain or swelling, flu-like symptoms due to immune activation (fever, chills), fatigue from Nivolumab therapy as well as potential impacts on organ function which will be closely monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1 Monotherapy: Maximum Tolerated Dose (MTD)
Part 1 Monotherapy: Safety and Tolerability assessed by Adverse Events (AEs)
Part 2 MEM-288 plus nivolumab combination: Overall Response Rate (ORR)
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DoR)
Overall Survival (OS)
+3 moreOther study objectives
Exploratory Biomarker Analysis
Side effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: MEM-288 Intratumoral InjectionExperimental Treatment1 Intervention
Part 1 MEM-288 monotherapy: Patients with accessible, subcutaneous, or superficial lymph node lesion ≥ 1 cm3 that is palpable will receive intratumoral injection of MEM-288 once every 3 week (planned 2 doses, maximum 6 doses) at one of three dose cohort levels.
* Dose cohort level 1 (1 x 10\^10 viral particles)
* Dose cohort level 2 (3.3 x 10\^10 viral particles)
* Dose cohort level 3 (1 x 10\^11 viral particles)
Group II: Dose combination of MEM-288 Intratumoral Injection plus anti-PD1 (Nivolumab) Intravenous InfusionExperimental Treatment2 Interventions
Part 2 MEM-288 plus nivolumab combination: Patients with accessible, subcutaneous, or superficial lymph node lesion ≥ 1 cm3 that is palpable will receive intratumoral injection of MEM-288 maximum total dose of 1x10\^11 viral particles once every 3 week (planned 2 doses, maximum 6 doses). MEM-288 may be injected in multiple lesions until the maximum injection dose (1x10\^11 viral particles) is reached (minimum dose per lesion of 1x10\^10 viral particles). Nivolumab 360 mg IV every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
Memgen, Inc.Lead Sponsor
Duke Cancer InstituteOTHER
16 Previous Clinical Trials
2,972 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteOTHER
561 Previous Clinical Trials
144,768 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease but it's not vitiligo, Grave's, or psoriasis that doesn't need systemic treatment.My pancreatic cancer has worsened after chemotherapy that included gemcitabine or a 5-FU-based treatment.I have melanoma and have been treated with BRAF inhibitors and anti-PD-1/PD-L1 inhibitors.I have no ongoing moderate side effects from immunotherapy, except for manageable hormone issues.My skin cancer got worse despite having standard treatments.I am fully active or can carry out light work.I do not have recent serious heart problems or uncontrolled heart disease.I am willing and able to follow the study's schedule and procedures.My Merkel cell carcinoma got worse despite immunotherapy.I am 18 years old or older.I have advanced cancer in the lung, skin, pancreas, breast, or head and neck.I have not had cancer vaccines or immune-stimulatory treatments except for FDA-approved ones.I am taking 10 mg or more of prednisone daily.I have had serious lung inflammation not caused by an infection.My advanced lung cancer progressed after initial treatment with anti-PD-1/PD-L1.I have been treated with a specific drug for my EGFR or ALK positive cancer.My tumor can be safely biopsied and is larger than 1 cm3.I had brain cancer spread, treated it, feel no symptoms, stopped steroids 7 days ago, and my scans are stable with a life expectancy over 3 months.I am not pregnant, can use birth control, and have a recent negative pregnancy test.I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.My breast cancer treatment included taxane or anthracycline.My blood counts and kidney, liver functions are within required ranges.I stopped a previous immunotherapy because of severe side effects.I haven't had major surgery or serious injury in the last 4 weeks, or I've recovered from their side effects.I have severe side effects from cancer treatment, except for hair loss.I have head and neck cancer, treated with platinum and PD-1/PD-L1 inhibitors but it has progressed.I am currently on IV antibiotics for an infection.My NSCLC has worsened despite standard treatments, including platinum chemotherapy and targeted therapy for specific gene changes.My cancer is advanced and is one of the specified types.
Research Study Groups:
This trial has the following groups:- Group 1: MEM-288 Intratumoral Injection
- Group 2: Dose combination of MEM-288 Intratumoral Injection plus anti-PD1 (Nivolumab) Intravenous Infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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