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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 below
Select...
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 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

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).

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
3,822 Previous Clinical Trials
5,014,534 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
~52 spots leftby Nov 2024