22 Participants Needed

Nivolumab + Ipilimumab for Melanoma

kR
Overseen Bykayla Rosati, EdM
Stay on Your Current MedsYou can continue your current medications while participating
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
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you must stop them at least 14 days before starting the trial treatment.

What data supports the effectiveness of the drug combination Nivolumab and Ipilimumab for treating melanoma?

Research shows that combining Nivolumab and Ipilimumab leads to better outcomes for patients with advanced melanoma, including higher response rates and longer survival times, compared to using Ipilimumab alone.12345

Is the combination of Nivolumab and Ipilimumab safe for treating melanoma?

The combination of Nivolumab and Ipilimumab for melanoma can lead to increased risk of immune-related side effects, which can be more frequent and severe than when using each drug alone. Common side effects include fatigue, diarrhea, and skin reactions, but most are reversible with treatment. Close monitoring by experienced healthcare providers is important to manage these side effects effectively.678910

How is the drug Nivolumab + Ipilimumab unique for treating melanoma?

Nivolumab and ipilimumab work together to boost the immune system's ability to fight melanoma by targeting different pathways, leading to better response rates and longer survival compared to using ipilimumab alone. This combination is unique because it uses two different types of immune checkpoint inhibitors to enhance the body's natural defenses against cancer.2341112

What is the purpose of this trial?

Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma. High dose interferon is a standard of care in the adjuvant setting but is highly toxic and marginally effective. The combination of ipilimumab and nivolumab is the most active regimen in patients with advanced melanoma so there is clear rationale to test this regimen in the adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be six months.

Research Team

HS

Howard Safran, MD

Principal Investigator

BrUOG Study Chair

Eligibility Criteria

Adults over 18 with high-risk melanoma that's been surgically removed can join. They should be healthy enough for treatment (ECOG 0-1), not have had other cancer treatments except surgery or radiation, and must agree to use birth control. People with certain medical conditions, previous immunotherapy, active infections like hepatitis B/C or HIV, pregnant/breastfeeding women, and those with brain metastases cannot participate.

Inclusion Criteria

You are not pregnant or breastfeeding. If you can have children, you need a negative pregnancy test before starting the treatment. If you have not had a period for over a year or had surgery that caused menopause, you do not need a pregnancy test.
My cancer was surgically removed, it had spread to my lymph nodes but I am now disease-free.
My blood, liver, and kidney functions meet the study's required levels.
See 5 more

Exclusion Criteria

I have been treated with drugs targeting PD-1, PD-L1, or CTLA-4.
I am currently undergoing treatment for cancer.
I have tested positive for HIV/AIDS.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab 3mg/kg every 2 weeks and ipilimumab 1mg/kg every 6 weeks for a total of 6 months

6 months
12 visits (in-person) for nivolumab, 4 visits (in-person) for ipilimumab

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ipilimumab
  • Nivolumab
Trial Overview The trial is testing a combination of two drugs: Nivolumab (3mg/kg every 2 weeks) and Ipilimumab (1mg/kg every 6 weeks) as an adjuvant therapy for six months in patients who've had their melanoma surgically removed but are at high risk of it coming back. The goal is to see if this regimen can prevent the cancer from returning better than current standard care.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Adjuvant treatmentExperimental Treatment2 Interventions
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)

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

🇺🇸
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
🇪🇺
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
🇨🇦
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
🇨🇭
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?

Maria Constantinou

Lead Sponsor

Trials
2
Recruited
30+

Brown University

Lead Sponsor

Trials
480
Recruited
724,000+

Rhode Island Hospital

Collaborator

Trials
275
Recruited
71,400+

The Miriam Hospital

Collaborator

Trials
252
Recruited
39,200+

Findings from Research

In a study of 142 patients with advanced melanoma, the combination of nivolumab and ipilimumab resulted in a significantly higher objective response rate of 61% compared to 11% for ipilimumab alone, indicating that the combination therapy is much more effective for treating this type of cancer.
While the combination therapy showed promising efficacy, it also had a higher incidence of severe adverse events (54% vs. 24% for monotherapy), but most of these side effects were manageable with immune-modulating medications.
Nivolumab and ipilimumab versus ipilimumab in untreated melanoma.Postow, MA., Chesney, J., Pavlick, AC., et al.[2022]
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]
In a phase 2 trial involving 142 patients with untreated advanced melanoma, the combination of nivolumab and ipilimumab resulted in a 2-year overall survival rate of 63.8%, compared to 53.6% for those receiving ipilimumab alone, suggesting improved survival outcomes with the combination therapy.
However, the combination treatment was associated with a higher incidence of severe side effects, with 54% of patients experiencing grade 3-4 adverse events compared to 20% in the ipilimumab-only group, indicating a trade-off between efficacy and safety.
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.Hodi, FS., Chesney, J., Pavlick, AC., et al.[2022]

References

Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. [2022]
Nivolumab plus Ipilimumab Achieves Responses in dMMR/MSI-H Tumors. [2019]
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. [2022]
Nivolumab plus ipilimumab in advanced melanoma. [2022]
Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. [2023]
Combined immune checkpoint blockade (anti-PD-1/anti-CTLA-4): Evaluation and management of adverse drug reactions. [2022]
Nivolumab Plus Relatlimab Is Safe and Efficacious in Pretreated Melanoma. [2023]
First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients. [2022]
Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. [2023]
Successful Treatment of Multiple Metastatic Melanoma with Nivolumab, Ipilimumab plus Denosumab Combined Therapy. [2020]
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