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Virus Therapy

CMP-001 + Nivolumab for Melanoma

Phase 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years at time of consent
Eastern Cooperative Oncology Group Performance Status of 0 to 1 at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of drug (week 1 day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining a drug given intravenously with one injected directly into tumors. The objective is to see if this is effective and safe for people with melanoma that has not responded to other treatments.

Who is the study for?
Adults over 18 with advanced melanoma that can't be surgically removed or has spread, who have not responded to PD-1 blocking therapy. They must understand the study, agree to use birth control if applicable, and have adequate organ function. Excluded are those with certain types of melanoma, recent treatments or vaccinations, severe illnesses including heart disease or mental illness, less than a 3-month life expectancy, previous CMP-001 treatment, active infections including COVID-19 and hepatitis B/C or HIV.Check my eligibility
What is being tested?
The trial is testing CMP-001 given directly into tumors combined with Nivolumab through IV in patients whose melanoma hasn't improved with standard treatments. The main goal is to see how well this combination works on the cancer. Safety and drug levels in the body will also be checked.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites for CMP-001 and typical immune-related side effects from Nivolumab such as inflammation in organs like lungs (pneumonitis), liver issues, skin problems, hormone gland changes (like thyroid), digestive tract symptoms and potential infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with advanced or untreatable malignant melanoma.
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You have not responded to treatment with PD-1 blockers either alone or with other medications, based on certain criteria.
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You are able to provide a small piece of tissue from a biopsy.
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Your organs are working well based on specific blood test results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of drug (week 1 day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of drug (week 1 day 1) until 30 days after the last drug 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
Determine confirmed objective response (ORR) with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma
Secondary outcome measures
Assess and describe the immunogenicity of CMP-001 in combination with nivolumab by detecting development of anti-Qbeta antibodies in subjects with refractory unresectable or metastatic melanoma
Pyruvate Kinase
Assess the PK profile of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma for area under the serum concentration-time curve from time zero extrapolated to infinity
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CMP-001 and NivolumabExperimental Treatment2 Interventions
All enrolled subjects will receive CMP-001 IT and nivolumab 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
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,988 Total Patients Enrolled
177 Trials studying Melanoma
57,499 Patients Enrolled for Melanoma
Regeneron PharmaceuticalsLead Sponsor
619 Previous Clinical Trials
380,211 Total Patients Enrolled
13 Trials studying Melanoma
5,146 Patients Enrolled for Melanoma
Checkmate PharmaceuticalsLead Sponsor
10 Previous Clinical Trials
655 Total Patients Enrolled
5 Trials studying Melanoma
319 Patients Enrolled for Melanoma

Media Library

CMP-001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04698187 — Phase 2
Melanoma Research Study Groups: CMP-001 and Nivolumab
Melanoma Clinical Trial 2023: CMP-001 Highlights & Side Effects. Trial Name: NCT04698187 — Phase 2
CMP-001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04698187 — Phase 2

Frequently Asked Questions

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

What are the general applications of Nivolumab?

"Nivolumab is an effective treatment option for malignant neoplasms, inoperable melanoma, and squamous cell carcinomas."

Answered by AI

In which venues is this clinical research being administered?

"Numerous medical centres are participating in this clinical trial, including The Ohio State University in Columbus and Sammons Cancer Center in Dallas; furthermore, GenesisCare USA is recruiting patients from Jacksonville as well as another 25 locations."

Answered by AI

To what degree can Nivolumab be detrimental to individuals?

"Based on the available clinical evidence, nivolumab scored a 2 out of 3 in terms of safety rating. This is because although there are some data affirming its safety profile, no studies have yet demonstrated efficacy."

Answered by AI

How many participants have enrolled in this investigation?

"Unfortunately, no more applicants are being accepted for this particular trial. The study was initially posted on February 10th 2021 and edited lastly on August 1st 2022. Though, there are still 765 clinical trials recruiting melanoma patients and 718 studies actively looking for participants to be treated with Nivolumab."

Answered by AI

Is this trial a novel approach to treatment?

"At the moment, 718 active trials are examining Nivolumab in over 2356 cities and 49 nations. This pharmaceutical was first studied back in 2012 by Ono Pharmaceutical Co. Ltd., with 659 patients participating across its Phase 1 & 2 clinical stages. Since then, a total of 254 studies have been concluded."

Answered by AI

Are there any prior investigations involving Nivolumab that can be referenced?

"Nivolumab was initially studied in 2012 at Local Institution and has since undergone 254 completed trials. Moreover, there are currently 718 active studies being conducted globally - with a disproportionately high number occurring around Columbus, Ohio."

Answered by AI

Are there any remaining vacancies for participants in this research project?

"According to official documentation found on clinicaltrials.gov, this trial is no longer recruiting participants and was last updated on August 1st 2022. Nevertheless, there are still 1483 other studies that require patient volunteers at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
2021. "CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04698187.
~11 spots leftby Apr 2025
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