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Virus Therapy

CMP-001 + Nivolumab for Melanoma

Phase 2 & 3

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

Capable of understanding and complying with protocol requirements

Male subjects must be surgically sterile or use adequate contraception

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 studying CMP-001 in combination with nivolumab compared to nivolumab monotherapy as a first-line treatment for unresectable or metastatic melanoma. The primary objective of Phase 2 of the study is to determine the confirmed ORR for treatment with CMP-001/nivolumab vs nivolumab monotherapy.

Who is the study for?

Adults with advanced melanoma that hasn't spread to the eyes, hands, feet or mucous membranes. They haven't had systemic treatment for metastatic melanoma and have no history of certain allergies or immune deficiencies. Participants must not be pregnant, should use contraception, and have good organ function.Check my eligibility

What is being tested?

The trial is testing CMP-001 given directly into tumors combined with Nivolumab via IV versus just Nivolumab alone. It aims to see if the combination works better for treating unresectable or metastatic melanoma without surgery.See study design

What are the potential side effects?

Potential side effects include reactions at injection sites, flu-like symptoms from CMP-001; fatigue, skin issues, respiratory problems like pneumonitis from Nivolumab; both can potentially worsen autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

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

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I understand and can follow the study's requirements.

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I am a man who is either surgically sterile or using reliable birth control.

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I am not pregnant and will use birth control during the study.

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I am 18 years old or older.

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My organ functions are within normal ranges.

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I can provide a tissue sample from a biopsy.

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My melanoma is at an advanced stage and cannot be surgically removed.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until 30 days after last cmp-001 injection (until a reason for treatment discontinuation occurs)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until 30 days after last cmp-001 injection (until a reason for treatment discontinuation occurs)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until 30 days after 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

Phase 2: Determine confirmed objective response with CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma

Phase 3: Evaluate progression-free survival for subjects receiving CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma

Secondary outcome measures

Phase 2 & 3: Evaluate the safety & tolerability of CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma defined by AEs, SAEs, & AEs leading to discontinuation or death & severity of AEs.

Phase 3: Confirmed objective response rate (ORR)

Phase 3: Disease control rate (DCR)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nivolumab MonotherapyExperimental Treatment1 Intervention

All enrolled subjects will receive nivolumab monotherapy IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Group II: 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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,494 Total Patients Enrolled

177 Trials studying Melanoma

57,523 Patients Enrolled for Melanoma

Checkmate PharmaceuticalsLead Sponsor

10 Previous Clinical Trials

679 Total Patients Enrolled

5 Trials studying Melanoma

343 Patients Enrolled for Melanoma

Regeneron PharmaceuticalsLead Sponsor

615 Previous Clinical Trials

379,827 Total Patients Enrolled

13 Trials studying Melanoma

5,170 Patients Enrolled for Melanoma

Media Library

CMP-001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04695977 — Phase 2 & 3

Melanoma Research Study Groups: CMP-001 and Nivolumab, Nivolumab Monotherapy

Melanoma Clinical Trial 2023: CMP-001 Highlights & Side Effects. Trial Name: NCT04695977 — Phase 2 & 3

CMP-001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04695977 — Phase 2 & 3

Frequently Asked Questions

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

How many people are currently enrolled in this clinical trial?

"This particular trial is no longer looking for candidates. The listing was first posted on February 5th, 2021 and last updated on August 1st, 2022. There are currently 793 other trials involving melanoma patients and 747 trials using Nivolumab that are actively recruiting participants."

Answered by AI

For what type of illnesses is Nivolumab commonly prescribed?

"Nivolumab is primarily used to target and shrink malignant neoplasms. However, it can also help patients with other conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Are there other case studies that feature Nivolumab?

"Nivolumab was first researched in 2010 at H. Lee Moffitt Cancer Center and Research Institute; since then, there have been 251 completed trials worldwide. As of now,747 trials are still active; many of these studies taking place in Los Angeles, California."

Answered by AI

How many different hospitals in the city are conducting this clinical trial?

"There are 20+ locations where this trial is being conducted, with a few notable hospitals being University of California, Los Angeles in Los Angeles, California, California Cancer Associates for Research & Excellence, Inc. in San Marcos, Ohio, and The Ohio State University Wexner Medical Center in Columbus, Georgia."

Answered by AI

Are there any previous cases similar to this one?

"Nivolumab has been the focus of 747 clinical trials since 2010. Out of these studies, 251 have completed all phases and been published. The initial study was sponsored by Medarex and involved 127 patients. Currently, active trials for Nivolumab are being conducted across 2347 cities in 50 different countries."

Answered by AI

What goals does this trial hope to achieve?

"The purpose of this clinical trial is, over the course of approximately one month after receiving their last CMP-001 injection or until discontinuation for another reason, to determine if CMP-001 in combination with nivolumab is more effective than nivolumab monotherapy in subjects with unresectable or metastatic melanoma. Secondary objectives include assessing iPFS, TR in non-injected target lesions, and iDOR."

Answered by AI

Are there any current openings for people who want to participate in this trial?

"This study is not recruiting participants at this time, according to the latest information on clinicaltrials.gov. The trial was first posted on February 5th, 2021 and was last updated on August 1st, 2022. There are 1540 other studies currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma

2021. "CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04695977.

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