Study Group for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Angeles Clinic at Cedars Sinai, Los Angeles, CA
Melanoma+1 More
Ipilimumab Injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The study will evaluate how safe the study drug is, how well you tolerate it, and how it works in the body and the disease's response to the drug. The study drug being tested is sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in patients with stage III or stage IV melanoma that cannot be removed by surgery. Previous studies have provided a strong rationale for combining sarilumab, with ipilimumab, nivolumab and relatlimab in metastatic melanoma to reduce side effects and potentially work better for this type of cancer. Sarilumab is an FDA-approved inhibitor of the receptor for the cytokine IL-6, currently approved for the treatment of rheumatoid arthritis, but it is not FDA-approved to treat melanoma. This means that the use of Sarilumab to treat melanoma is considered investigational. The other drugs which will be administered in this study, ipilimumab and nivolumab, are also monoclonal antibodies, but they target different proteins. Ipilimumab and nivolumab are both approved by the FDA to treat advanced stage III and IV melanomas. The nivolumab + relatlimab FDC (fixed dose combination) being used in this study is considered investigational, meaning it is not approved by the FDA.

Eligible Conditions

  • Melanoma
  • Unresectable Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Month 31

Month 31
Disease Control Rate (DCR)
Duration of Immune-related Disease Control
Duration of Immune-related Overall Response
Duration of Overall Response
Immune-related Disease Control Rate per irRC criteria
Immune-related Progression-Free Survival (irPFS)
Immune-related Response Rate (irRR) per irRC criteria
Up to Month 31
Duration of disease control
Overall survival (OS)
Progression-free survival (PFS)
Week 24
Best overall response (iBOR)
Number of Grades 3-5 Treatment-Related Immune-Related Adverse Events (irAE) per NCI CTCAE v 5.0 Criteria
Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Category

Trial Safety

Safety Progress

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

Trial Design

1 Treatment Group

Study Group
1 of 1
Experimental Treatment

69 Total Participants · 1 Treatment Group

Primary Treatment: Study Group · No Placebo Group · Phase 2

Study GroupExperimental Group · 3 Interventions: Ipilimumab Injection, Sarilumab, Nivolumab/Relatlimab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab Injection
2019
Completed Phase 2
~20
Sarilumab
2020
Completed Phase 3
~5860

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 31
Closest Location: Angeles Clinic at Cedars Sinai · Los Angeles, CA
Photo of Los Angeles  1Photo of Los Angeles  2Photo of Los Angeles  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Melanoma
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have signed and dated an Institutional Review Board/Independent Ethics Committee -approved written informed consent form in accordance with regulatory and institutional guidelines.
You have a melanoma, regardless of primary site of disease.
Patients must not have received prior anticancer treatment for metastatic disease.
Patients must have their disease status documented by a complete physical examination and imaging studies within 4 weeks prior to the first dose of study drug.
The radiographs must be available before treatment initiation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.