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Virus Therapy

CMP-001 + Pembrolizumab for Squamous Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Checkmate Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically- or cytologically-confirmed recurrent or metastatic HNSCC considered incurable by local therapies
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of cmp-001 (week 1 day 1) until 30 days after the last cmp-001 injection (until a reason for treatment discontinuation occurs)
Awards & highlights

Study Summary

This trial is testing a new combination treatment for head and neck squamous cell carcinoma that consists of an intratumoral injection of CMP-001 followed by intravenous pembrolizumab. The goal is to see if this new treatment is more effective than pembrolizumab alone, and if it is well tolerated by participants.

Who is the study for?
This trial is for adults with head and neck squamous cell carcinoma who haven't had PD-1 blocking antibody treatment. They should have measurable disease, no recent non-systemic therapy, good organ function, and an ECOG status of 0 or 1. Women must test negative for pregnancy and agree to contraception; men must also use contraception.Check my eligibility
What is being tested?
The study tests CMP-001 given directly into the tumor combined with pembrolizumab in the vein on patients with head and neck cancer. It aims to see how well this combo works (main goal) and its safety (secondary goal). Treatment continues until it's not suitable anymore.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, immune-related issues due to pembrolizumab affecting organs like lungs or intestines, fatigue, skin conditions, hormonal changes, flu-like symptoms from CMP-001.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with advanced head and neck cancer that cannot be cured with local treatments like surgery or radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of cmp-001 (week 1 day 1) until 30 days after the last cmp-001 injection (until a reason for treatment discontinuation occurs)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of cmp-001 (week 1 day 1) until 30 days after the last cmp-001 injection (until a reason for treatment discontinuation occurs) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The objective response (investigator-assessed) to CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC).
Secondary outcome measures
Efficacy [characterized by DOR, PFS, and OS, along with Immune Objective Response Rate (iORR), Immune Duration of Response (iDOR), and Immune Progression-free Survival (iPFS)] of CMP-001 in combination with pembrolizumab in subjects with HNSCC.
Safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC.
The effect of human papillomavirus (HPV) infection and programmed death ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CMP-001 and PembrolizumabExperimental Treatment2 Interventions
All subjects will receive CMP-001 IT and pembrolizumab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CMP-001
2018
Completed Phase 2
~380
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Checkmate PharmaceuticalsLead Sponsor
10 Previous Clinical Trials
675 Total Patients Enrolled
Regeneron PharmaceuticalsLead Sponsor
613 Previous Clinical Trials
379,435 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
258 Previous Clinical Trials
250,675 Total Patients Enrolled

Media Library

CMP-001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04633278 — Phase 2
Oral Squamous Cell Carcinoma Research Study Groups: CMP-001 and Pembrolizumab
Oral Squamous Cell Carcinoma Clinical Trial 2023: CMP-001 Highlights & Side Effects. Trial Name: NCT04633278 — Phase 2
CMP-001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04633278 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment for this research project?

"Presently, this trial is not admitting any more patients. The clinical trial was originally posted on 11/30/2020 and was most recently edited on 11/11/2022. If you are seeking for other studies, there are presently 2761 studies actively admitting patients with oral squamous cell carcinoma and 1000 trials for Pembrolizumab actively enrolling patients"

Answered by AI

In how many places can people participate in this clinical trial?

"Currently, this trial is being conducted at 19 sites which include locations such as Iowa City, Houston and Little Rock. To reduce travel burdens, patients are encouraged to select the site nearest them."

Answered by AI

What is the precedence for using Pembrolizumab in medical treatments?

"Pembrolizumab is being studied in 1000 different clinical trials, 122 of which are currently recruiting patients. Many of the Pembrolizumab trials began in Houston, Texas; however, there are 36025 total locations for these studies."

Answered by AI

Is Pembrolizumab known to have harmful side effects?

"Pembrolizumab falls into the Phase 2 category, meaning that while there is some evidence of its safety, none exists for efficacy. Our team power estimated a score of 2."

Answered by AI

Are patients currently being enrolled in this clinical trial?

"Unfortunately, this study is no longer recruiting patients. The original posting was on November 30th 2020 but the listing was edited for the last time on November 11th 2022. However, there are 2761 other trials involving oral squamous cell carcinoma and 1000 studies that use Pembrolizumab currently admitting patients."

Answered by AI

What are some of the conditions that Pembrolizumab has been shown to be effective against?

"Pembrolizumab is a medication that oncologists often prescribe to cancer patients. In addition to its efficacy in treating malignant neoplasms, pembrolizumab can also help patients with unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI
~6 spots leftby Mar 2025