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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients who are not postmenopausal, and who have not undergone surgical sterilization, must agree to use highly effective methods of contraception during the treatment period and for 6 months after the last dose of study drug. They must also agree not to donate eggs (ova, oocytes) during the same timeframe
Have previously received anti-PD-1/L1 as monotherapy or in combination. A maximum of 2 prior lines of systemic therapy is allowed for BRAF wild-type disease and a maximum of 3 prior lines of systemic therapy is allowed for BRAFV600 positive disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to day 42
Awards & highlights
Study Summary
This trial studies a new drug for advanced melanoma to see if it's safe and effective alone or with other drugs.
Who is the study for?
Adults with advanced cutaneous melanoma who've had up to 3 prior systemic therapies (depending on BRAF gene status), have measurable disease, and are in good physical condition. They must agree to contraception use and not donate sperm or eggs during the trial. Excluded are those allergic to study drugs, with uncontrolled hepatitis B/C, active autoimmune diseases requiring recent treatment, certain heart conditions, untreated brain metastases, or other serious health issues.Check my eligibility
What is being tested?
The trial is testing ANV419 alone or combined with Pembrolizumab (anti-PD1 antibody) or Ipilimumab (anti-CTLA4 antibody) in adults with unresectable/metastatic skin cancer. It aims to assess how well these treatments work and their safety profiles.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs like the liver or lungs, infusion-related symptoms such as fever or chills, fatigue, skin reactions at injection sites, hormonal imbalances due to immune system effects on glands like the thyroid.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will use effective birth control during and for 6 months after treatment, and won't donate eggs in this time.
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I've had up to 2 treatments for my cancer if it's BRAF wild-type, or up to 3 if it's BRAFV600 positive.
Select...
My melanoma is at an advanced stage and cannot be surgically removed.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has worsened despite previous treatments.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 up to day 42
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to day 42
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ipilimumab
Combination Dose Finding: Incidence, frequency, and severity of Adverse Events with ANV419 in combination with pembrolizumab or ipilimumab
Combination Dose Finding: Recommended Phase 2 Dose of ANV419 in combination with ipilimumab
+2 moreSecondary outcome measures
Combination Dose Expansion: Duration of Complete Response (DCR) according to RECIST v1.1 and iRECIST
Combination Dose Expansion: Duration of Response (DOR) according to iRECIST and iRECIST
Combination Dose Expansion: Incidence, frequency, and severity of Adverse Events with ANV419 in combination with pembrolizumab or ipilimumab
+25 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: ANV419 single agent, dose 2, Q2WExperimental Treatment1 Intervention
Group II: ANV419 single agent, dose 1, Q2WExperimental Treatment1 Intervention
Group III: ANV419 + Pembrolizumab, Q3WExperimental Treatment2 Interventions
Group IV: ANV419 + Ipilimumab, Q3WExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Anaveon AGLead Sponsor
3 Previous Clinical Trials
94 Total Patients Enrolled
1 Trials studying Melanoma
10 Patients Enrolled for Melanoma
Claudia Schusterbauer, MDStudy DirectorAnaveon AG
3 Previous Clinical Trials
434 Total Patients Enrolled
Eduard Gasal, MDStudy DirectorAnaveon AG
2 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of my last cancer treatment or surgery.I will use effective birth control during and for 6 months after treatment, and won't donate eggs in this time.My brain metastases are stable, and I haven't used steroids in the last 7 days.I do not have uncontrolled hepatitis B or C, or if I do, it is being successfully treated.My side effects from previous immunotherapies are mild or back to normal, except for hair loss or tiredness.I have lung inflammation not caused by an infection.I have another cancer besides the one being studied, but it's either not active or was treated successfully over 2 years ago, except for certain skin cancers or in situ cervical cancer.I haven't taken any experimental drugs or devices recently, except for certain immune therapies.I have an immune system disorder or have been on immune-weakening medication recently.I am HIV positive but meet all the specific health criteria.I agree to use effective birth control and not donate sperm for 6 months after my last dose.I am allergic to ANV419, pembrolizumab, ipilimumab, or their ingredients like sucrose.I've had up to 2 treatments for my cancer if it's BRAF wild-type, or up to 3 if it's BRAFV600 positive.My melanoma is at an advanced stage and cannot be surgically removed.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.You have a disease that can be measured using specific guidelines.I am fully active or restricted in physically strenuous activity but can do light work.Your LDH blood test result is higher than normal.I have been diagnosed with melanoma in my eye or mucous membranes.Your heart's electrical activity is too slow, with an average QTcF interval longer than 470 milliseconds.I have had a heart attack or severe heart disease in the last 3 months.I have had an organ or stem cell transplant.My cancer has worsened despite previous treatments.I am taking more than 10 mg of prednisone daily or any immunosuppressive medication.My organs are functioning well.I stopped taking certain cancer drugs due to severe side effects not controlled by steroids.I am 18 years old or older.I have not received a live vaccine within the last 30 days.I have an infection that isn't getting better with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ANV419 + Ipilimumab, Q3W
- Group 2: ANV419 single agent, dose 2, Q2W
- Group 3: ANV419 + Pembrolizumab, Q3W
- Group 4: ANV419 single agent, dose 1, Q2W
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.
What is the cap on enrolment for this clinical trial?
"Yes, the evidence on clinicaltrials.gov attests to this medical trial's active participation in recruiting with an initial listing date of December 16th 2022 and most recent update happening on January 31st 2023. With only 1 centre involved, 130 patients must be recruited for successful completion."
Answered by AI
Are there any vacancies for prospective participants in this research endeavor?
"Affirmative. According to records posted on clinicaltrials.gov, this exploration of medical science is currently enrolling participants; it was initially published on December 16th 2022 and its most recent update was done January 31st 2023. A total of 130 volunteers are being sought across a single site."
Answered by AI
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