Nivolumab for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Melanoma+3 More
Nivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Melanoma
  • Unresectable Melanoma
  • Metastatic Melanoma
  • melanoma

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: From first dose of drug (Week 1 Day 1) until 30 days after last CMP-001 injection (until a reason for treatment discontinuation occurs)

Day 30
Phase 3: Evaluate progression-free survival for subjects receiving CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma
Phase 3: Overall survival (OS)
Week 1
Phase 3: Immune DOR (iDOR)
Phase 3: Immune ORR (iORR)
Phase 3: Immune PFS (iPFS)
Week 1
Phase 3: Confirmed objective response rate (ORR)
Phase 3: Disease control rate (DCR)
Phase 3: Duration of response (DOR)
Phase 3: Treatment response (TR) in non-injected target lesions
Week 1
Phase 2: Determine confirmed objective response with CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma
Day 30
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.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

CMP-001 and Nivolumab
1 of 2
Nivolumab Monotherapy
1 of 2

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Nivolumab · No Placebo Group · Phase 2 & 3

CMP-001 and NivolumabExperimental Group · 2 Interventions: Nivolumab, CMP-001 · Intervention Types: Drug, Drug
Nivolumab Monotherapy
Drug
Experimental Group · 1 Intervention: Nivolumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
CMP-001
2018
Completed Phase 1
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose of drug (week 1 day 1) until 30 days after last cmp-001 injection (until a reason for treatment discontinuation occurs)

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
543 Previous Clinical Trials
199,513 Total Patients Enrolled
9 Trials studying Melanoma
3,775 Patients Enrolled for Melanoma
Checkmate PharmaceuticalsLead Sponsor
10 Previous Clinical Trials
723 Total Patients Enrolled
5 Trials studying Melanoma
333 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,483 Previous Clinical Trials
3,919,856 Total Patients Enrolled
174 Trials studying Melanoma
58,175 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient's platelet count is greater than or equal to 100,000 per millimeter cubed.
The subject must have a recent biopsy (within 90 days before the first dose of study treatment) that can provide tissue from a core or excisional biopsy; a fine needle aspirate is not sufficient.
A hemoglobin concentration of 9 grams or greater per deciliter is required.
Cancer that is too widespread to be surgically removed, as confirmed by a tissue examination
At least 1 lesion that can be treated with injections of IT drugs.
One or more lesions that are at least 1 cm in diameter, that are not intended for injection with CMP-001, and can be followed using the RECIST v1.1 criteria.
A neutrophil count of 1500 or more per millimeter is considered high.
A white blood cell count of 2000/mm3 or more is considered high.
No subject with Gilbert disease had a total bilirubin concentration greater than 3 × the ULN.
The translated text is: "The levels of aspartate aminotransferase and alanine aminotransferase are 3 times the upper limit of normal or less.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.