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Cancer Vaccine
Nous-209 Vaccine for Metastatic Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Nouscom SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status of 0 or 1
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer vaccine in adults with metastatic cancer. The vaccine consists of two parts, given a few weeks apart. The first part is given as an injection, and the second part is given as a smallpox-like rash. The trial will test for safety and efficacy.
Who is the study for?
Adults over 18 with certain advanced solid tumors (like colorectal, gastric, or gastro-esophageal junction cancers) that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). They must not have used PD-1/PD-L1 inhibitors before and should be in a condition where they can handle biopsies. Participants need to have an acceptable performance status, meet specific blood criteria, use effective contraception if of childbearing potential, and understand the study's consent form.Check my eligibility
What is being tested?
The trial is testing Nous-209 genetic vaccine combined with pembrolizumab for treating MSI-H/dMMR tumors. It uses two types of viruses for priming and boosting the immune system. The first phase focuses on safety and finding the right dose; the second phase looks at how well it works against cancer.See study design
What are the potential side effects?
Possible side effects include typical vaccine reactions like soreness at injection site, fever, fatigue; immune-related issues such as inflammation in different body parts due to an overactive immune response; plus any known side effects from pembrolizumab which may include skin rash, itching, coughing or shortness of breath.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my usual activities without help.
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I am 18 years old or older.
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I have never been treated with anti-PD-1 or anti-PD-L1 drugs.
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My cancer was previously tested for dMMR/MSI status.
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I am able to care for myself and perform daily activities.
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My cancer is known to have high microsatellite instability or mismatch repair deficiency.
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My colorectal cancer cannot be surgically removed, has spread, and has worsened after initial improvement with anti-PD1 therapy.
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My cancer has been tested for dMMR/MSI status.
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I am not pregnant.
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My cancer is advanced and has not responded to at least two treatments.
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My colorectal cancer is advanced, cannot be surgically removed, and is eligible for immunotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) at any time during the study, in Phase II (Cohort C and D).
Safety and Tolerability, in Phase I, Cohort A and B.
Toxicity (DLT assessment), in Phase I, Cohort A
Secondary outcome measures
Immunogenicity (T cell responses against vaccine FSPs) in Phase I, Cohorts A and B
Safety and tolerability (local and systemic AEs), in Phase II (Cohort C and D)
Other outcome measures
Clinical: Best Overall Response (BOR), Phase II (Cohort C and D).
Clinical: Disease Control Rate (DCR), in Phase I, Cohort A and B
Clinical: Duration of Response (DoR), Phase I Main Study and Extended follow-up, Phase II (Cohost C and D)
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort D - Expansion cohort Phase IIExperimental Treatment3 Interventions
Phase II. Subjects with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who have had radiographic progression (PD) after having a best response of stable disease (SD) or better on/after anti-PD1 treatment. Nous-209 vaccine plus Keytruda® (pembrolizumab) combination therapy.
Group II: Cohort C - Expansion cohort Phase IIExperimental Treatment3 Interventions
Phase II. Subjects with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who are eligible for anti-PD-1 1st line of treatment. Subjects will be randomized with an allocation ratio 2:1 to Nous-209 vaccine plus Keytruda® (pembrolizumab) combination therapy versus pembrolizumab monotherapy.
Group III: Cohort B - Expansion Cohort Phase IExperimental Treatment3 Interventions
Phase I. Part 1. Expansion cohort at RP2D. Subjects treated with RP2D dose of GAd20-209-FSP prime and MVA-209-FSP boosts, in combination with pembrolizumab.
Phase I. Part 2 - Extended Follow-up from week 27 to week 110. Subjects with unresectable or metastatic dMMR or MSI-H CRC, gastric, or G-E junction tumors.
Group IV: Cohort A - Dose-escalationExperimental Treatment3 Interventions
Phase I. Part 1. Dose escalation cohort. Subjects treated with low dose or with high dose of GAd20-209-FSP prime and MVA-209-FSP boosts to define the RP2D, in combination with pembrolizumab.
Phase I. Part 2 - Extended Follow-up from week 27 to week 110. Subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KEYTRUDA®
2018
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,901 Previous Clinical Trials
5,062,844 Total Patients Enrolled
Nouscom SRLLead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
Patricia Delaite, MDStudy DirectorNouscom SRL
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or its coverings.I can carry out all my usual activities without help.I am using effective birth control methods.I agree to have two biopsies if it's safe for me.You are pregnant or currently breastfeeding.I am 18 years old or older.I do not have chronic illnesses that would affect my participation in the study.I have or might have an autoimmune disease.You have a health or psychological condition that the doctor thinks would make it unsafe for you to participate in the study.I have never been treated with anti-PD-1 or anti-PD-L1 drugs.You have experienced a severe allergic reaction (anaphylaxis) to a vaccine in the past.I have not had any radiotherapy in the last 2 weeks, or 4 weeks if it was for my brain.My cancer was previously tested for dMMR/MSI status.I had another type of cancer but have been free of it for 2 years after treatment.My condition worsened despite receiving approved treatments.I have an autoimmune disease but it's not severe, except for thyroid issues or psoriasis.I am able to care for myself and perform daily activities.I have fluid buildup in my abdomen causing symptoms.I am currently being treated for a severe infection.I have an active hepatitis B or C infection needing treatment.I have been diagnosed with HIV.I have been using steroids or immunosuppressants recently.I've had radiation on over half of my lymph node groups.I have used immunosuppressive drugs in the last 3 months.You had a tissue or organ transplant from another person before.I will not need any cancer treatment other than the study drugs while participating.I do not have active lung disease needing steroids or oxygen levels below 92%.My cancer is known to have high microsatellite instability or mismatch repair deficiency.My colorectal cancer cannot be surgically removed, has spread, and has worsened after initial improvement with anti-PD1 therapy.You have mental health or drug-related problems that could make it difficult for you to follow the trial requirements.I have previously received immunotherapy for my cancer.I had severe side effects from previous immune therapy that needed long-term treatment.I had major surgery less than 4 weeks before starting pembrolizumab.I have fluid buildup in my abdomen.I have another cancer that won't affect this treatment's safety or results.You have used illegal drugs regularly or had issues with drugs or alcohol within the past year.My cancer has been tested for dMMR/MSI status.I have not taken growth factors in the last 4 weeks.I have not received a live-virus vaccine within the last 30 days.You are allergic to egg proteins.I am using effective birth control methods.I am not pregnant.My cancer is advanced and has not responded to at least two treatments.I have not been in a clinical trial for a new treatment or device within the last 4 weeks, or 12 weeks if it was for immunotherapy.I have been treated with immune system targeting drugs before.I agree to a biopsy before starting the trial for the new vaccine.My side effects from the last chemotherapy are mild now, except for hair loss.I have an active Hepatitis B or C infection.I have an abscess inside my abdomen.I have a known history of HIV or AIDS.My colorectal cancer is advanced, cannot be surgically removed, and is eligible for immunotherapy.My side effects from the last chemotherapy are mild, except for hair loss.I have a condition that weakens my immune system.You are expected to live for at least 6 more months.I need surgery for a blockage in my digestive tract.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A - Dose-escalation
- Group 2: Cohort B - Expansion Cohort Phase I
- Group 3: Cohort C - Expansion cohort Phase II
- Group 4: Cohort D - Expansion cohort Phase II
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.
How many healthcare facilities are actively engaged in this experiment?
"This research is currently being conducted in 6 different cities, including New york, Baltimore and Duarte. To minimize travel burden for potential participants, it may be beneficial to select the nearest location."
Answered by AI
How many individuals have volunteered for this research endeavor?
"Affirmative. The details of this medical trial hosted on clinicaltrials.gov suggests that it is actively searching for participants, which was originally posted in October 21st 2019 and last edited in October 2nd 2022. 115 individuals are needed to be recruited from 6 different sites."
Answered by AI
Could you provide information about any past experiments that utilized MVA-209-FSP, RP2D?
"Firstly observed at Dana-Farber Cancer Institute in 2015, MVA-209-FSP, RP2D has since been tested through 75 clinical trials. At present time, 16 of these trials are still active and the majority of them take place within New york City."
Answered by AI
What are the criteria for enrolling in this research endeavor?
"This trial is recruiting 115 participants aged 18-85 who are presently living with cancer and meet the additional criteria outlined below. Eligibility necessitates a prior diagnosis of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status, an Eastern Cooperative Oncology Group Performance Score of 0 or 1, adequate hematological values as specified in Table 1, recovery from any toxic effects of previous chemotherapy to Grade 1 or less, life expectancy exceeding 6 months, and consent for baseline biopsy and potential on-treatment biopsies if deemed acceptable. Female subjects must present negative pregnancy test results within"
Answered by AI
What is the goal of this experiment?
"This clinical trial aims to evaluate Dose Limiting Toxicities (DLT) in Cohort A over an 18-month period. Secondary objectives include Immunogenicity evaluations by IFN-gamma ELISpot for both Cohorts A and B, Safety and tolerability assessments using NCI CTCAE v5.0 standards for Phase IIa's Cohort C, with all data collected at 6, 12, and 18 months via RECIST v1.1 criteria."
Answered by AI
Is this experiment open to individuals aged 45 or above?
"This trial has an age restriction with the minimum being 18 years old and the upper limit set at 85."
Answered by AI
Is enrollment still available for this clinical research study?
"Per the data on clinicaltrials.gov, this medical experiment is actively looking for participants and has been since October 21st 2019 with its most recent update provided on October 2nd 2022."
Answered by AI
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