70 Participants Needed

Ipilimumab + Nivolumab for Melanoma

Recruiting at 17 trial locations
JW
MP
Overseen ByMichael Postow, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
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

Will I have to stop taking my current medications?

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 may need to stop them at least 14 days before starting the study drugs.

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

Research shows that combining Ipilimumab and Nivolumab significantly improves the chances of tumor response and prolongs the time patients live without the disease getting worse, compared to using Ipilimumab alone in advanced melanoma.12345

Is the combination of Ipilimumab and Nivolumab safe for humans?

The combination of Ipilimumab and Nivolumab can cause immune-related side effects, which are often mild to moderate but can be severe in some cases. These side effects are due to the drugs' action on the immune system, and they require careful monitoring and management. While more studies are needed, current data from real-world use and clinical trials suggest that the safety profile includes reactions from each drug when used alone.56789

How is the drug combination of Ipilimumab and Nivolumab unique for treating melanoma?

The combination of Ipilimumab and Nivolumab is unique because it targets two different immune checkpoints, CTLA-4 and PD-1, enhancing the body's immune response against melanoma. This combination has shown better outcomes in terms of response rates and survival compared to using Ipilimumab alone.1341011

What is the purpose of this trial?

This study will help determine whether 2 doses of the combination (ipilimumab + nivolumab) is sufficient for patients with early benefit compared to the usual way of trying to give 4 doses. If patients do not show early benefit after 2 doses, patients will be able to continue with additional ipilimumab + nivolumab, even beyond the standard 4 doses if felt in the best interest of the patient.

Research Team

Michael A. Postow, MD - MSK Melanoma ...

Michael A. Postow

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with unresectable stage III or IV melanoma who haven't had CTLA-4 or PD-1/PD-L1 therapy. They must have a life expectancy of at least 4 months, be in good physical condition (ECOG 0-1), and women must use effective contraception. Exclusions include severe allergies, mental impairments, other serious illnesses, active autoimmune diseases requiring steroids or immunosuppressants, certain neuropathies, another active cancer, known immunodeficiency or viral hepatitis.

Inclusion Criteria

My melanoma cannot be removed by surgery and is stage III or IV.
I haven't received CTLA-4 or PD-1/PD-L1 therapy for my metastatic disease.
I use two birth control methods and will continue for 23 weeks after my last treatment dose.
See 3 more

Exclusion Criteria

I don't have another cancer that needs treatment or affects melanoma tests.
I am able to understand and follow the study's requirements.
I do not have any serious illnesses like infections needing antibiotics or bleeding disorders.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive 2 doses of ipilimumab 3mg/kg + nivolumab 1mg/kg every 3 weeks

6 weeks
2 visits (in-person)

Response Assessment

Participants are assessed for antitumor effect by RECIST at week 6

1 week
1 visit (in-person)

Maintenance Treatment

Participants with favorable response receive maintenance nivolumab 480mg every 4 weeks for 2 doses

4 weeks
2 visits (in-person)

Extended Treatment

Participants without favorable response receive additional ipilimumab + nivolumab every 3 weeks, reassessed at week 12

6 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ipilimumab and Nivolumab Combination Immunotherapy
Trial Overview The study tests if two doses of ipilimumab plus nivolumab are as effective as the usual four doses for patients showing early benefits from treatment. Patients without early benefit can continue receiving additional doses beyond the standard four if deemed beneficial.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ipilimumab and nivolumabExperimental Treatment2 Interventions
Pts will receive 2 doses of ipilimumab 3mg/kg + nivolumab 1mg/kg every 3 weeks. Week 6, if pts have achieved a favorable antitumor effect by RECIST will begin maintenance nivolumab alone at 480mg every 4 weeks for 2 doses (week 6 \& week 10) \& repeat response assessments at week 12. If pts don't achieve a favorable antitumor effect at week 6, pt will get 2 additional doses of ipilimumab + nivolumab every 3 weeks \& then will be assessed for response at week 12. If pts haven't achieved a favorable antitumor effect by week 12, if felt in the best interest for the pt as determined by the PI, pts may continue getting additional doses of ipilimumab + nivolumab with response reassessments after every 2 doses. Maintenance nivolumab will continued until unacceptable toxicity or confirmed disease progression. If pts have had an initial clinical benefit from therapy \& subsequently experience progressive disease at any time, reinduction with combination ipilimuma+ nivolumab will be allowed.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

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

Findings from Research

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]
In a phase 1 trial involving 53 patients with advanced melanoma, the combination of nivolumab and ipilimumab resulted in a 40% objective response rate, with 65% of patients showing clinical activity, indicating significant effectiveness in tumor reduction.
The concurrent treatment had a manageable safety profile, with 53% of patients experiencing grade 3 or 4 adverse events, which were similar to those seen with monotherapy and generally reversible, suggesting that this combination therapy is a viable option for patients.
Nivolumab plus ipilimumab in advanced melanoma.Wolchok, JD., Kluger, H., Callahan, MK., et al.[2022]
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]

References

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]
Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. [2022]
Nivolumab plus Ipilimumab Achieves Responses in dMMR/MSI-H Tumors. [2019]
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]
CTLA-4 blockade with ipilimumab: biology, safety, efficacy, and future considerations. [2022]
Risk of immune-related adverse events associated with ipilimumab-plus-nivolumab and nivolumab therapy in cancer patients. [2022]
Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. [2023]
Successful Treatment of Multiple Metastatic Melanoma with Nivolumab, Ipilimumab plus Denosumab Combined Therapy. [2020]
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