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Cancer Vaccine

V940 + Pembrolizumab for Skin Cancer

Phase 2 & 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)

Has LA Stage II-IV (M0) cSCC without distant metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~59 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a personalized treatment called V940 along with pembrolizumab in patients with advanced skin cancer. The study has two parts, Phase 2 and Phase 3. Phase

Who is the study for?

This trial is for adults with a specific type of skin cancer called locally advanced cutaneous squamous cell carcinoma (LA cSCC) that can be surgically removed. Participants must not be pregnant or breastfeeding and should use effective contraception if applicable. They need to have a life expectancy over 3 months, good performance status, and proper organ function.

What is being tested?

The study tests V940, an individualized neoantigen therapy, combined with pembrolizumab versus standard care alone or pembrolizumab alone in LA cSCC patients. It's given before and after surgery to see if it improves event-free survival compared to the usual treatment.

What are the potential side effects?

Potential side effects include those common to immunotherapies like fatigue, skin reactions, inflammation in organs as well as complications from surgery such as infection or poor wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin cancer is confirmed and can be surgically removed.

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My skin cancer is at an advanced stage but hasn't spread to distant parts.

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My skin cancer can be removed with surgery aimed at curing it.

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I can provide a suitable tumor sample for advanced genetic testing.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~59 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~59 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~59 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event Free Survival (EFS)

Secondary study objectives

Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30)

Change from baseline in Role functioning score of QLQ-C30 Items 6-7

Change from baseline in physical functioning score of QLQ (C30 Items 1-5)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab with SOCExperimental Treatment2 Interventions

Participants will receive pembrolizumab 400 mg IV infusion q6w up to 12 weeks as neoadjuvant therapy prior to surgery; followed by pembrolizumab 400 mg IV infusion q6w or until discontinuation.

Group II: Pembrolizumab plus V940 with SOCExperimental Treatment3 Interventions

Participants will receive V940 1 mg intramuscular (IM) injection every 3 weeks (q3w) for up to 6 weeks and pembrolizumab 400 mg intravenous (IV) infusion every 6 weeks (q6w) up to 12 weeks as neoadjuvant therapy prior to surgery; followed by V940 1 mg IM injection q3w up to 21 weeks and pembrolizumab 400 mg IV infusion q6w or until discontinuation.

Group III: Standard of Care (SOC)Active Control1 Intervention

Participants will receive surgical resection as per local guidelines with/without adjuvant radiation therapy (RT) at investigator's discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Surgery

2000