42 Participants Needed

Nivolumab + Relatlimab for Advanced Cancer

Recruiting at 1 trial location
TB
JS
CA
Overseen ByColleen Apostal, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Must be taking: PD-1/PD-L1 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy, radiation, or steroids within 14 days before starting the study treatment. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug combination Nivolumab + Relatlimab for advanced cancer?

Research shows that the combination of nivolumab and relatlimab is more effective than nivolumab alone in treating melanoma, a type of skin cancer, especially in patients who have not been treated before. This combination has been approved for use in the USA for treating advanced melanoma, indicating its effectiveness.12345

Is the combination of Nivolumab and Relatlimab safe for humans?

Nivolumab plus relatlimab has a manageable safety profile in patients with advanced pretreated melanoma.24678

What makes the drug combination of Nivolumab and Relatlimab unique for advanced cancer?

The combination of Nivolumab and Relatlimab is unique because it targets two different immune checkpoints, PD-1 and LAG-3, enhancing the immune system's ability to fight cancer. This dual-target approach is novel and was first approved for treating advanced melanoma, offering a new option for patients with this condition.245910

Research Team

DL

Dung Le, MD

Principal Investigator

Johns Hopkins Medical Institution

Eligibility Criteria

Adults with advanced cancers that have high microsatellite instability and didn't respond to previous PD-1/PD-L1 inhibitor therapy. Participants must be in good physical condition, have at least one measurable lesion, proper organ and marrow function, no severe allergies to monoclonal antibodies or history of certain diseases like interstitial lung disease or brain metastases.

Inclusion Criteria

I am fully active or can carry out light work.
My organ and bone marrow functions meet the study's requirements.
My heart's pumping ability is normal.
See 6 more

Exclusion Criteria

I currently have an active infection.
I have or had cancer spread to my brain.
Had any investigational cytotoxic drug within 4 weeks prior to study treatment.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab and relatlimab in various dosing regimens for advanced mismatch repair deficient cancers

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

  • Nivolumab
  • Relatlimab
Trial Overview The trial is testing the combination of Nivolumab and Relatlimab for effectiveness and safety in patients whose tumors are resistant to prior therapies targeting PD-(L)1 proteins. It aims to see if this new treatment can help control cancer growth.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Cohort 3: Nivolumab and RelatlimabExperimental Treatment2 Interventions
480mg/480mg (sequential administration)
Group II: Cohort 2: Nivolumab and RelatlimabExperimental Treatment2 Interventions
480mg/960mg or 480mg/160mg (sequential administration)
Group III: Cohort 1: Nivolumab and RelatlimabExperimental Treatment2 Interventions
480mg/160mg (co-administered)

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Opdivo for:
  • Advanced or metastatic gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Hepatocellular carcinoma
  • Esophageal squamous cell carcinoma
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
๐Ÿ‡จ๐Ÿ‡ญ
Approved in Switzerland as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Combining nivolumab with ipilimumab results in higher response rates in cancer treatment compared to using nivolumab alone, indicating a potentially more effective therapeutic strategy.
This combination therapy may enhance the immune response against cancer, but specific details on the number of subjects or study duration are not provided in the abstract.
Nivolumab plus Ipilimumab Achieves Responses in dMMR/MSI-H Tumors.[2019]
Nivolumab plus relatlimab is a combination immunotherapy that targets immune checkpoints, specifically PD-1 and LAG-3, and has been approved for treating unresectable or metastatic melanoma in adults and adolescents weighing at least 40 kg.
This combination therapy represents a significant advancement in cancer treatment, as it utilizes two different mechanisms to enhance the immune response against cancer cells.
Nivolumab Plus Relatlimab: First Approval.Paik, J.[2022]
In a study of 129 patients with advanced melanoma treated with nivolumab and relatlimab, those without diabetes had significantly better progression-free survival (PFS) and overall survival (OS) compared to patients with type 2 diabetes, indicating that diabetes negatively impacts treatment efficacy.
Interestingly, patients who developed immune checkpoint inhibitor-induced diabetes (ICI-DM) during treatment had the best outcomes, suggesting that this condition may enhance the effectiveness of the therapy, possibly due to changes in LAG3 expression in tumor tissue.
The role of diabetes in metastatic melanoma patients treated with nivolumab plus relatlimab.Mallardo, D., Woodford, R., Menzies, AM., et al.[2023]

References

Nivolumab plus Ipilimumab Achieves Responses in dMMR/MSI-H Tumors. [2019]
Nivolumab Plus Relatlimab: First Approval. [2022]
The role of diabetes in metastatic melanoma patients treated with nivolumab plus relatlimab. [2023]
Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]
Nivolumab, anti-programmed death-1 (PD-1) monoclonal antibody immunotherapy: Role in advanced cancers. [2023]
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis. [2023]
Nivolumab Plus Relatlimab Is Safe and Efficacious in Pretreated Melanoma. [2023]
Toxicity profile of approved anti-PD-1 monoclonal antibodies in solid tumors: a systematic review and meta-analysis of randomized clinical trials. [2022]
Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. [2023]
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]