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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Overall Survival (OS)
+3 moreOther outcome measures
Exploratory Biomarker Analysis
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
2014
Completed Phase 3
~4750
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
543 Previous Clinical Trials
135,434 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the MEM-288 Intratumoral Injection pose any potential hazards for patients?
"Our team assigned MEM-288 Intratumoral Injection a safety rating of 1 due to the limited amount of data available in this Phase 1 trial, which is insufficient for assessing its efficacy and security."
Answered by AI
Are there vacancies available for participants in this research program?
"The listing of this clinical study on clinicaltrials.gov indicates that it is actively enrolling participants. The trial was initially posted in February 23rd 2022 and the details have been updated most recently on June 27th 2022."
Answered by AI
How many participants are involved in this research endeavor?
"Affirmative, the data available on clinicaltrials.gov suggests that enrollment for this trial is ongoing and started from February 23rd 2022. The latest update was made June 27th of the same year and 18 volunteers are required to be recruited across 2 sites."
Answered by AI
What are the core goals of this medical experiment?
"The primary outcome variable of interest, as specified by Memgen Inc., the study sponsor; is Maximum Tolerated Dose (MTD) and will be assessed over a 4.5 month period. Secondary endpoints being examined are Overall Survival (OS), Disease Control Rate(DCR), and Overall Response Rate (ORR). These variables will all be evaluated using the Response Evaluation Criteria in Solid Tumors 1.1 standard."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
Duke Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
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