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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

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).

Find a Location

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

Media Library

CyPep-1 (Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT05383170 — Phase 1 & 2
Head and Neck Cancers Research Study Groups: Arm B: advanced or metastatic melanoma, Arm C: advanced or metastatic TNBC, Arm A: advanced or metastatic HNSCC
Head and Neck Cancers Clinical Trial 2023: CyPep-1 Highlights & Side Effects. Trial Name: NCT05383170 — Phase 1 & 2
CyPep-1 (Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05383170 — Phase 1 & 2

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."

Answered by AI
Recent research and studies
~33 spots leftby Nov 2024