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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

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).

0 / 17Eligibility criteria met

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

New England Journal of MedicineJournal

Genetic Basis for Clinical Response to CTLA-4 Blockade in Melanoma

Snyder, Alexandra, Vladimir Makarov, Taha Merghoub, Jianda Yuan, Jesse M. Zaretsky, Alexis Desrichard, Logan A. Walsh, et al.. 2014. “Genetic Basis for Clinical Response to CTLA-4 Blockade in Melanoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1406498.

The Lancet OncologyJournal

Irecist: Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics

Seymour, Lesley, Jan Bogaerts, Andrea Perrone, Robert Ford, Lawrence H Schwartz, Sumithra Mandrekar, Nancy U Lin, et al.. 2017. “Irecist: Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(17)30074-8.

Journal of Clinical OncologyJournal

Response Criteria for Intratumoral Immunotherapy in Solid Tumors: Itrecist

Goldmacher, Gregory V., Anuradha D. Khilnani, Robert H. I. Andtbacka, Jason J. Luke, F. Stephen Hodi, Aurelien Marabelle, Kevin Harrington, et al.. 2020. “Response Criteria for Intratumoral Immunotherapy in Solid Tumors: Itrecist”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.02985.

Annals of the New York Academy of SciencesJournal