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Checkpoint Inhibitor
Voyager V1 + Cemiplimab for Melanoma
Phase 2
Recruiting
Research Sponsored by Vyriad, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least one tumor lesion amenable to IT injection and biopsy that has not been previously irradiated.
Performance status of 0 or 1 on the ECOG Performance Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug, VV1, to see if it is safe and effective when used with cemiplimab to treat patients with NSCLC or melanoma.
Who is the study for?
Adults with certain progressing cancers (oral, head and neck carcinoma, melanoma, colorectal) previously treated with CPI can join. They must have a tumor lesion suitable for injection/biopsy, measurable disease, good performance status (ECOG 0 or 1), over three months life expectancy, and proper organ function. Exclusions include ocular/mucosal/acral melanoma patients; active HBV/HCV/TB infections; serious health risks like uncontrolled hypertension/diabetes; recent use of certain drugs; heart issues; autoimmune diseases except controlled hypothyroidism/type 1 diabetes; immunosuppression conditions.Check my eligibility
What is being tested?
The trial is testing the combination of VV1 and Cemiplimab to see how well they work together against specific types of cancer that are not responding to previous treatments. It's in Phase 2 which means it's checking both effectiveness and safety in treating these cancers.See study design
What are the potential side effects?
Possible side effects may include typical reactions from immune therapies such as inflammation in different parts of the body, allergic reactions at the infusion site, fatigue, changes in blood tests indicating liver or kidney issues. Each patient might experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be injected and biopsied, and it hasn't been treated with radiation.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) per imaging assessment
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0
Serum concentration time
To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ
Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
Trial Design
3Treatment groups
Experimental Treatment
Group I: Melanoma intratumoralExperimental Treatment2 Interventions
Melanoma, IT VV1 + IV cemiplimab Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses.
Group II: Head and Neck SCC intratumoralExperimental Treatment2 Interventions
HNSCC, IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses.
Group III: Colo-rectal Carcinoma intratumoralExperimental Treatment2 Interventions
IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
Vyriad, Inc.Lead Sponsor
5 Previous Clinical Trials
190 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
618 Previous Clinical Trials
380,146 Total Patients Enrolled
13 Trials studying Melanoma
5,103 Patients Enrolled for Melanoma
Naimish Pandya, MDStudy DirectorClinical Lead
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe autoimmune diseases except well-controlled hypothyroidism or type 1 diabetes.I am currently infected with hepatitis B.My cancer can be measured and has at least one lesion that can be injected.I stopped taking small molecule inhibitors or other trial drugs less than 2 weeks ago.I haven't had a severe infection in the last 2 weeks.I am HIV positive with an active infection.I am 18 years old or older.I have a tumor that can be injected and biopsied, and it hasn't been treated with radiation.I am not on high doses of steroids or have a weak immune system.My recent tests show my organs are working well.I have severe heart issues, including arrhythmias or symptomatic coronary artery disease.I have a history of active or latent tuberculosis.I have been diagnosed with a specific type of melanoma affecting the eyes, mucous membranes, or extremities.I am currently infected with Hepatitis C.I haven't had certain cancer treatments in the last 3 weeks or 5 half-lives, whichever is shorter.I do not have any serious health conditions that would make this study unsafe for me.I haven't had certain experimental cancer treatments in the last 6 weeks.I have another type of cancer besides the one being treated.I am fully active or restricted in physically strenuous activity but can do light work.I am open to trying a different treatment that could potentially cure my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Head and Neck SCC intratumoral
- Group 2: Colo-rectal Carcinoma intratumoral
- Group 3: Melanoma intratumoral
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.
Are there available vacancies for participants in this experiment?
"Affirmative. The clinical trial is currently enrolling as per the information hosted on clinicaltrials.gov. This research program was inaugurated April 24th 2020 and has been revised most recently on April 21st 2022, with 152 participants sought from 10 various medical facilities."
Answered by AI
How many research centers are actively participating in this trial?
"At present, 10 clinical trial sites have been identified to recruit patients for this study. Sioux Falls, Minneapolis and New Haven are some of the locales involved in addition to other areas which can be found on our website. To minimize travel demands, please choose a location closest to you when signing up."
Answered by AI
What is the upper boundary of participants in this trial?
"According to Vyriad, Inc., the sponsor of this trial, 152 participants meeting its inclusion criteria are necessary for successful completion. Patients can be seen at Sanford Cancer Center in Sioux Falls and Masonic Cancer Center, University of Minnesota located in Minneapolis."
Answered by AI
Has the Food and Drug Administration provided its stamp of approval for VV1?
"Our research group at Power gave VV1 a score of 2, as Phase 2 trials offer evidence in support of safety but lack data regarding treatment efficacy."
Answered by AI
What else has been learned from other investigations involving VV1?
"VV1 was first explored by City of Hope in 2010, and has since been the subject of 6 completed clinical trials. At present, 56 studies are still running - predominantly based out of Sioux Falls, South dakota."
Answered by AI
What are the customary applications of VV1?
"VV1 is often prescribed to treat alk gene mutation, as well as more complex conditions such as metastatic cutaneous squamous cell carcinoma and malignant neoplasms."
Answered by AI
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