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Peptide
CyPep-1 + Pembrolizumab for Advanced Cancers (Catalyst Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Cytovation AS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients of childbearing potential must meet specific criteria
Male patients able to father children must meet specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Catalyst Trial Summary
This trial will test a new cancer treatment combining two drugs. It will assess how well the treatment works, if it is safe, and how it affects the body.
Who is the study for?
Adults with advanced or metastatic cancers such as head and neck, breast, melanoma, or squamous cell carcinoma. Participants must have a measurable tumor for injection, be able to provide biopsy tissue, have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and adequate organ function. Pregnant women, those with recent cancer treatments or surgeries, certain infections like HIV/SARS-CoV-2/Hepatitis B/C, autoimmune diseases requiring immunosuppression within the last two years are excluded.Check my eligibility
What is being tested?
The trial is testing CyPep-1 injected into tumors combined with pembrolizumab (Keytruda) infusion. It aims to evaluate how safe and effective this combination is against various cancers by observing its impact on both treated and untreated tumor sites as well as overall immune response.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site for CyPep-1 and typical immune-related adverse effects from pembrolizumab such as fatigue, skin issues, inflammation of organs like lungs (pneumonitis), liver problems; also possible are flu-like symptoms and allergic reactions.
Catalyst Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children and meet specific health criteria.
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I am a man who can father children and meet specific requirements.
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My organs are functioning well, tested within 3 days before starting the treatment.
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I can provide a recent biopsy sample or have one stored from the last 90 days.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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I have a tumor that can be reached for injection and is not an open sore.
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I am a woman who cannot become pregnant.
Catalyst Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of DLTs
Incidence, frequency, and seriousness of TEAEs
ORR based on radiological assessment according to the RECIST v1.1
Secondary outcome measures
OS
PFS
Catalyst Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C: advanced or metastatic TNBCExperimental Treatment2 Interventions
The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Group II: Arm B: advanced or metastatic melanomaExperimental Treatment2 Interventions
The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Group III: Arm A: advanced or metastatic HNSCCExperimental Treatment2 Interventions
The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
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Who is running the clinical trial?
Cytovation ASLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,610 Total Patients Enrolled
Cesar Pico, MDStudy DirectorCytovation AS
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a transplant of tissue, organ, stem cell, or bone marrow.You have unusual blood clotting test results as determined by the study doctor.You have a measurable tumor according to specific guidelines for assessing cancer.You had bad reactions to treatments like pembrolizumab.I have a heart condition related to abnormal heart rhythms.My cancer has spread to 4 or more places, including where it started.I am allergic to ingredients in CyPep-1 or pembrolizumab.You have tested positive for the coronavirus within the 14 days before the screening visit.I am not under legal protection, vulnerable, or unable to give informed consent.I am a woman who can have children and meet specific health criteria.I am a man who can father children and meet specific requirements.I have or had lung inflammation not caused by infection, treated with steroids.My organs are functioning well, tested within 3 days before starting the treatment.I have a history of Hepatitis B or active Hepatitis C.I can provide a recent biopsy sample or have one stored from the last 90 days.I am fully active or restricted in physically strenuous activity but can do light work.I have brain metastases that are causing symptoms or getting worse.I have not been in a clinical trial or received experimental therapy within the last 30 days.My skin cancer cannot be felt by touch.I haven't had cancer treatment in the last 4 weeks (2 weeks for palliative radiotherapy).I have not had a live vaccine within 30 days before starting CyPep-1.I am 18 years old or older.I am currently being treated for an infection.I have a tumor that can be reached for injection and is not an open sore.I received radiotherapy less than 2 weeks before starting CyPep-1.I have another cancer that is growing or needs treatment, except for early skin cancer or carcinoma in situ.I am HIV positive.I haven't needed immunosuppressive therapy for an autoimmune disease in the last 2 years.I am a woman who cannot become pregnant.You have a history of serious allergic reactions or Quincke's edema.I have not had major surgery in the last 2 weeks.I will need cancer treatment during the study, but not just local pain relief radiation.I have been on steroids or other immune-weakening drugs in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: advanced or metastatic melanoma
- Group 2: Arm C: advanced or metastatic TNBC
- Group 3: Arm A: advanced or metastatic HNSCC
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 people with specific medical conditions currently being accepted into this clinical trial?
"This trial is not recruiting at the moment, as indicated by clinicaltrials.gov. This information is current as of May 16th, 2022-- the most recent date that the study was edited. Although this research project isn't looking for volunteers presently, there are 5579 other trials that are still open to recruitment."
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