Duvelisib + Nivolumab for Melanoma
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, you should avoid medications or foods that strongly affect a liver enzyme called CYP3A within 2 weeks before starting the study. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug combination Duvelisib and Nivolumab for treating melanoma?
Research shows that Nivolumab, when used alone or in combination with other drugs like ipilimumab, has been effective in treating advanced melanoma, improving survival rates and disease control. This suggests that combining Nivolumab with other treatments, like Duvelisib, could potentially be beneficial for melanoma patients.12345
What safety information is available for Duvelisib and Nivolumab in humans?
Nivolumab, also known as Opdivo, has been used in treating melanoma and is generally considered safe, with common side effects including tiredness, diarrhea, constipation, nausea, muscle pain, rash, and itching. There is no specific safety data available for Duvelisib in this context, but it has been studied for other conditions.34678
How is the drug combination of Duvelisib and Nivolumab unique for treating melanoma?
The combination of Duvelisib and Nivolumab for melanoma is unique because it combines a PI3K inhibitor (Duvelisib) with a PD-1 checkpoint inhibitor (Nivolumab), potentially offering a novel approach by targeting both cancer cell growth and immune system activation, which is different from standard treatments that typically focus on one mechanism.19101112
What is the purpose of this trial?
This trial is a Phase I/II study in which a combination of duvelisib and nivolumab will be used to treat a total of patients diagnosed with advanced unresectable melanoma who have progressed on anti-PD1 therapy. The Recommended Phase II Dose of oral duvelisib will be determined and administered with intravenous nivolumab 480mg for up to 1 year or until the patient's disease does not progress or the patient experiences unacceptable side effects to treatment.
Research Team
John Kirkwood, MD
Principal Investigator
UPMC Hillman Cancer Center
Eligibility Criteria
Adults (18+) with advanced unresectable melanoma that worsened after anti-PD1 therapy can join. They must have measurable disease, be willing to use effective birth control, and have normal organ/bone marrow function. Excluded are those with significant infections, recent treatments, allergies to trial drugs, CNS metastases unless stable, autoimmune diseases except mild ones like type I diabetes or skin disorders not needing systemic treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive duvelisib orally in varying doses and nivolumab intravenously to determine the recommended dose for Phase II
Phase II Treatment
Participants receive the recommended dose of duvelisib and nivolumab for up to 1 year or until disease progression or unacceptable side effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Duvelisib
- Nivolumab
Duvelisib is already approved in United States for the following indications:
- Relapsed or refractory chronic lymphocytic leukemia (CLL)
- Relapsed or refractory small lymphocytic lymphoma (SLL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
John Kirkwood
Lead Sponsor
Secura Bio, Inc.
Industry Sponsor
Bristol-Myers Squibb
Industry Sponsor
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
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania