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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Distant-metastasis free survival (DMFS)
Major Pathologic Response Rate (MPR)
Pathologic Complete Response (pCR) Rate
Secondary outcome measures
Adverse Events at Least Possibly Related to Study Treatment
Overall Survival (OS)
Relapse-Free Survival (RFS)
+1 more
Other outcome measures
CD8+ T cell density

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
~4750

Find a Location

Who is running the clinical trial?

CellSight Technologies, Inc.Industry Sponsor
17 Previous Clinical Trials
275 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,506,840 Total Patients Enrolled
19 Trials studying Melanoma
177,662 Patients Enrolled for Melanoma
Melanoma Research FoundationOTHER
2 Previous Clinical Trials
75,034 Total Patients Enrolled
2 Trials studying Melanoma
75,034 Patients Enrolled for Melanoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04401995 — Phase 2
Melanoma Research Study Groups: Nivolumab and Vidutolimod (CMP-001) Combination with [18F]F-AraG PET/CT, Nivolumab with [18F]F-AraG PET/CT
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04401995 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04401995 — Phase 2

Frequently Asked Questions

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

Does this clinical investigation introduce a new concept?

"At present, there are 718 active studies for [18F]F-AraG PET/CT in 2354 cities and 49 nations. The pioneering trial was launched by Ono Pharmaceutical Co. Ltd back in 2012 with 659 participants who completed both Phases 1 & 2 of the drug approval stage. In the 8 years since then, 254 trials have been concluded successfully."

Answered by AI

Could you provide a synopsis of the research that has been conducted utilizing [18F]F-AraG PET/CT?

"Currently, there are 718 studies actively evaluating [18F]F-AraG PET/CT with 82 trials in the late stages of development. While a considerable portion of these experiments occur in Zürich, Belgium, data reveals that 40237 sites worldwide are running related research."

Answered by AI

What illnesses is [18F]F-AraG PET/CT being employed to treat?

"[18F]F-AraG PET/CT is frequently used in cancer treatment, particularly for malignant neoplasms. However it can also be utilized to combat other conditions such as metastatic esophageal adenocarcinoma, squamous cell carcinoma and unresectable melanoma."

Answered by AI

Are there opportunities to join this experiment currently available?

"Clinicaltrials.gov implies that this medical trial is actively enrolling participants. The original listing was published on September 2nd 2020 and the post has been recently modified on November 8th 2022."

Answered by AI

To what extent could [18F]F-AraG PET/CT be harmful to individuals?

"Our assessment of [18F]F-AraG PET/CT's safety is a 2, seeing as this is an ongoing Phase II trial - there is evidence to suggest that it has no major risks but its efficacy still needs further study."

Answered by AI

What outcome is this research attempting to accomplish?

"This clinical trial, set to be assessed over an 8-10 week timeframe, seeks to determine the Immune-related Major Pathologic Response rate. Secondary objectives include gauging Adverse Events at Least Possibly Related to Study Treatment according to CTCAE Version 5.0 criteria, Relapse-Free Survival rates and Overall Survival times of enrolled patients."

Answered by AI

How many volunteers have enrolled in this clinical experiment?

"Yes, the records on clinicaltrials.gov demonstrate that this medical trial is presently recruiting participants. The study was posted in September 2020 and updated November 2022, with 26 individuals required to be recruited from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab
Diwakar Davar 2020. "Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04401995.
~20 spots leftby Jul 2028
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