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Peptide
CyPep-1 + Pembrolizumab for Advanced or Metastatic 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
Have histologically confirmed diagnosis of malignant melanoma
Is able to provide tissue from a core or excisional biopsy at screening or has an acceptable stored tumor sample available that was collected within 90 days prior to screening
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Head and Neck Cancers
- Breast Cancer
- Melanoma
Catalyst Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You don't have melanoma in your eye.
Select...
You have advanced or metastatic head and neck cancer that cannot be treated with standard therapies.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
3,822 Previous Clinical Trials
5,014,534 Total Patients Enrolled
Cesar Pico, MDStudy DirectorCytovation AS
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have advanced or metastatic head and neck cancer that cannot be treated with standard therapies.You don't have melanoma in your eye.
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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