13 Participants Needed

Duvelisib + Nivolumab for Melanoma

AR
Overseen ByAmy Rose, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JK

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

I can take care of myself but might not be able to do heavy physical work.
My organs and bone marrow are functioning normally.
Ability to understand and the willingness to sign a written informed consent document.
See 5 more

Exclusion Criteria

I have had T-vec therapy, but not more than three patients like me can join the Phase II study.
I had a severe immune reaction in my gut but tolerated treatment after anti-CTLA-4 therapy.
I had severe side effects from previous immune therapy, but they are now under control.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive duvelisib orally in varying doses and nivolumab intravenously to determine the recommended dose for Phase II

8 weeks
Bi-weekly visits for nivolumab administration

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

Up to 1 year
Monthly visits for nivolumab administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

  • Duvelisib
  • Nivolumab
Trial Overview The study tests a combination of oral duvelisib and intravenous nivolumab in patients with advanced melanoma who didn't respond to previous anti-PD1 therapy. The Phase I part determines the safe dose for Phase II where it's given up to one year or until disease progression or unacceptable side effects occur.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Duvelisib plus NivolumabExperimental Treatment2 Interventions
Phase 1: Duvelisib will be taken orally in doses from 15mg once a day, 25mg once a day or 25mg twice a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks if deemed appropriate by the study doctor. Phase II: The Recommended Phase II dosage of duvelisib administered will not be determined until Phase I is completed. Nivolumab, 480mg, IV, every 4 weeks, for up to 1 year.

Duvelisib is already approved in United States for the following indications:

🇺🇸
Approved in United States as Copiktra for:
  • 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

Trials
6
Recruited
130+

Secura Bio, Inc.

Industry Sponsor

Trials
9
Recruited
200+

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

Nivolumab (Opdivo) monotherapy led to complete regression of local recurrence and multiple lung metastases in a patient with recurrent skin melanoma and a positive BRAF mutation, demonstrating its efficacy as a treatment option.
After 5 courses of nivolumab, the patient experienced significant improvement in her condition, achieving an ECOG performance status of 0, indicating a return to an active lifestyle without pain, and normal serum LDH levels.
[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)].Samsonia, M., Kandelaki, M., Gibradze, O., et al.[2021]
Nivolumab is shown to be the most cost-effective treatment option for advanced melanoma patients in England, with incremental cost-effectiveness ratios of £24,483 for BRAF mutation-negative and £17,362 for mutation-positive patients.
The analysis utilized a Markov state-transition model based on patient-level data from clinical trials, indicating that nivolumab provides long-term survival benefits while being economically favorable compared to other treatments.
The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England.Meng, Y., Hertel, N., Ellis, J., et al.[2020]
In a study of 355 patients with metastatic melanoma resistant to anti-PD-(L)1 therapy, combining ipilimumab with anti-PD-1 (either pembrolizumab or nivolumab) resulted in a significantly higher objective response rate (31%) compared to ipilimumab alone (13%).
Patients receiving the combination therapy also experienced longer overall survival (20.4 months vs. 8.8 months) and longer progression-free survival (3.0 months vs. 2.6 months), while the rates of severe adverse events were similar between the two treatment groups.
Ipilimumab alone or ipilimumab plus anti-PD-1 therapy in patients with metastatic melanoma resistant to anti-PD-(L)1 monotherapy: a multicentre, retrospective, cohort study.Pires da Silva, I., Ahmed, T., Reijers, ILM., et al.[2021]

References

1.Georgia (Republic)pubmed.ncbi.nlm.nih.gov
[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)]. [2021]
The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England. [2020]
Ipilimumab alone or ipilimumab plus anti-PD-1 therapy in patients with metastatic melanoma resistant to anti-PD-(L)1 monotherapy: a multicentre, retrospective, cohort study. [2021]
Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. [2022]
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]
FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. [2018]
Safety and efficacy of durvalumab (MEDI4736) in various solid tumors. [2022]
First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients. [2022]
Nivolumab: a review of its use in patients with malignant melanoma. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. [2023]
Nivolumab-induced hypothyoidism with consequent hypothyroid related myopathy. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Measuring Toxic Effects and Time to Treatment Failure for Nivolumab Plus Ipilimumab in Melanoma. [2023]
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