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Checkpoint Inhibitor

Vidutolimod + Nivolumab for Melanoma

Phase 2

Waitlist Available

Led By Diwakar Davar, MD, M.Sc

Research Sponsored by Diwakar Davar

Eligibility Criteria Checklist

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

Must have

Be ≥ 18 years of age on day of signing informed consent

Diagnosis of histologically or cytologically confirmed diagnosis of cutaneous melanoma belonging to specific AJCC TNM stages

Must not have

History of uveal or mucosal melanoma

Diagnosis of immunodeficiency or receiving systemic steroid therapy within 7 days prior to the first dose of trial treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to see if a treatment is working for melanoma that has spread to the lymph nodes or in-transit/satellite areas.

Who is the study for?

This trial is for adults with a specific type of skin cancer called cutaneous melanoma, who can consent to the study and are willing to undergo PET scans and tumor biopsies. They must not be pregnant or breastfeeding, agree to use birth control, have no other active cancers or recent treatments, and should not have immune system problems.

What is being tested?

The study is testing how effective nivolumab alone or combined with Vidutolimod (CMP-001) is in treating melanoma that affects lymph nodes or nearby skin areas. It also looks at changes in PET scan results before and after these treatments.

What are the potential side effects?

Nivolumab may cause fatigue, skin reactions, issues with lung function like coughing or shortness of breath, hormonal gland problems leading to mood swings or tiredness, liver inflammation causing nausea or yellowing of the skin/eyes. Vidutolimod's side effects are currently under investigation but could be similar.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My skin cancer is confirmed as melanoma at a specific stage.

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My cancer can be measured and is suitable for injection treatments.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had melanoma in my eye or mucous membranes.

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I have an immune system disorder or have taken steroids in the week before starting the trial.

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My cancer has spread to my brain.

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I have another cancer that is getting worse or needs treatment.

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I am taking more than 10mg of prednisone daily for my condition.

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I have a lung condition not caused by an infection.

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I am currently on medication for an infection.

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I have been treated with specific inhibitors before.

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I have a history of HIV or active Hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Distant-metastasis free survival (DMFS)

Major Pathologic Response Rate (MPR)

Pathologic Complete Response (pCR) Rate

Secondary study objectives

Adverse Events at Least Possibly Related to Study Treatment

Overall Survival (OS)

Relapse-Free Survival (RFS)

+1 more

Other study objectives

CD8+ T cell density

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nivolumab with [18F]F-AraG PET/CTExperimental Treatment2 Interventions

Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3. Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.

Group II: Nivolumab and Vidutolimod (CMP-001) Combination with [18F]F-AraG PET/CTExperimental Treatment3 Interventions

Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2. Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Vidutolimod (CMP-001)

2020

Completed Phase 2

~10