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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
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Is 18 years of age or older on the day of signing informed consent
Must not have
Has had a prior allogeneic tissue/solid organ transplant, stem cell, or bone marrow transplant
Has a QTcF >480 ms at screening, history of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial tests a new treatment that injects a special protein and an immune-boosting drug into tumors. It targets patients with advanced or hard-to-treat cancers. The treatment helps the immune system recognize and attack cancer cells.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a transplant of tissue, organ, stem cell, or bone marrow.
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I have a heart condition related to abnormal heart rhythms.
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I am allergic to ingredients in CyPep-1 or pembrolizumab.
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My cancer has spread to 4 or more places, including where it started.
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I am not under legal protection, vulnerable, or unable to give informed consent.
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I have or had lung inflammation not caused by infection, treated with steroids.
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I have a history of Hepatitis B or active Hepatitis C.
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I have brain metastases that are causing symptoms or getting worse.
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My skin cancer cannot be felt by touch.
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I haven't had cancer treatment in the last 4 weeks (2 weeks for palliative radiotherapy).
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I have not had a live vaccine within 30 days before starting CyPep-1.
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I am currently being treated for an infection.
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I have another cancer that is growing or needs treatment, except for early skin cancer or carcinoma in situ.
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I am HIV positive.
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I haven't needed immunosuppressive therapy for an autoimmune disease in the last 2 years.
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I have not had major surgery in the last 2 weeks.
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I will need cancer treatment during the study, but not just local pain relief radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CyPep-1
2020
Completed Phase 2
~70
Pembrolizumab 25 MG/ML [KEYTRUDA®]
2020
Completed Phase 2
~70
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Head and Neck Cancers include surgery, radiation therapy, chemotherapy, and immunotherapy. Surgery aims to physically remove the tumor, while radiation therapy uses high-energy rays to kill cancer cells.
Chemotherapy involves drugs that target rapidly dividing cells, including cancer cells. Immunotherapy, such as pembrolizumab, enhances the body's immune response against cancer by inhibiting the PD-1 pathway, which tumors use to evade immune detection.
The investigational treatment CyPep-1, when combined with pembrolizumab, is designed to have direct anti-tumor effects and potentially enhance systemic immune responses. This dual approach is significant for patients as it may improve the efficacy of treatment by not only targeting the tumor directly but also by boosting the body's natural defenses against cancer.
Find a Location
Who is running the clinical trial?
Cytovation ASLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,965 Previous Clinical Trials
5,176,422 Total Patients Enrolled
Cesar Pico, MDStudy DirectorCytovation AS
Media Library
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.
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