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CyPep-1

Phase 1

Advanced Head and Neck Squamous Cell Carcinoma | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Nov 28, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

CyPep-1 · 1 trial · 3 indications

Phase 1 1
NCT05383170A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic CancersAdvanced Head and Neck Squamous Cell Carcinoma
COMPLETED6 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers
Advanced Head and Neck Squamous Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency, and Seriousness of TEAEs
For each subject, from the time of signing the ICF until 30 days (90 days for SAEs) after the last dose of study treatment up to a maximum of 18 months.

Number of CyPep-1 related TEAEs per grading.

Incidence of DLTs
Initial 6 weeks of treatment.

Number of DLTs

Secondary Endpoints

PFS Per RECIST v1.1
Up to approximately 18 months
OS Per RECIST v1.1
Up to approximately 18 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: advanced or metastatic HNSCCEXPERIMENTALThe 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).
Arm B: advanced or metastatic melanomaEXPERIMENTALThe 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).
Arm C: advanced or metastatic TNBCEXPERIMENTALThe 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).

Interventions

NameTypeDescription
CyPep-1DRUGIntratumoral injection
Pembrolizumab 25 MG/ML [KEYTRUDA®]DRUGIV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: General Inclusion Criteria 1. Is 18 years of age or older on the day of signing informed consent; 2. Provides written informed consent and is able to comply with study procedures and assessments; 3. Has measurable disease as determined by the Response Evaluation Criteria in Sol...

Countries:United StatesFranceItalyNetherlandsSpain
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Frequently asked questions about CyPep-1

What is CyPep-1 used for in advanced head and neck squamous cell carcinoma?

CyPep-1 is an investigational small molecule being studied for the treatment of advanced head and neck squamous cell carcinoma. It is being evaluated in combination with pembrolizumab for advanced or metastatic cancers, including head and neck squamous cell carcinoma, breast cancer, and melanoma. CyPep-1 is currently in Phase 1 clinical development.

Who makes CyPep-1?

CyPep-1 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for the treatment of advanced head and neck squamous cell carcinoma.

What phase is CyPep-1 in?

CyPep-1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study evaluating CyPep-1 in combination with pembrolizumab for advanced or metastatic cancers has been completed.

What clinical trials is CyPep-1 in?

CyPep-1 has been studied in one clinical trial, identified as NCT05383170. This Phase 1 study evaluated the safety and efficacy of CyPep-1 in combination with pembrolizumab for the treatment of advanced or metastatic cancers, including head and neck squamous cell carcinoma, breast cancer, and melanoma. The trial enrolled 6 participants and has been completed.

Is CyPep-1 the same as pembrolizumab?

No, CyPep-1 is not the same as pembrolizumab. CyPep-1 is an investigational small molecule being developed by Merck & Company, Inc. Pembrolizumab is a separate drug that was used in combination with CyPep-1 in a clinical trial for the treatment of advanced or metastatic cancers.