~5 spots leftby Dec 2025

Duvelisib + Nivolumab for Skin Cancer

Recruiting at 17 trial locations
JR
Overseen ByJia Ruan
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests duvelisib and nivolumab in patients with advanced mycosis fungoides and Sezary syndrome. Duvelisib blocks cancer cell growth, and nivolumab boosts the immune system to fight cancer. The goal is to find the best dose and see if this combination works better than current treatments.

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

The trial protocol does not specify if you must stop all current medications, but there are some restrictions. You cannot be on strong inhibitors or inducers of CYP3A4, and you must stop any systemic therapy for MF/SS with specific washout periods: 8 weeks for low-dose total skin electron beam therapy, 4 weeks for systemic cytotoxic agents or tumor-targeting monoclonal antibodies (except alemtuzumab, which is 16 weeks), 2 weeks or 5 half-lives for systemic retinoids and other specified agents, 2 weeks for local radiation, and 1 week for topical retinoids and other specified topical treatments. You can continue using inhaled steroids and certain topical steroids if stable for at least 4 weeks. Please consult with the trial team for guidance on your specific medications.

What data supports the idea that Duvelisib + Nivolumab for Skin Cancer is an effective treatment?

The available research shows that Nivolumab, one of the drugs in the Duvelisib + Nivolumab combination, has been effective in treating advanced melanoma, a type of skin cancer. It was the first drug of its kind to show long-term survival benefits in clinical trials for advanced melanoma patients. However, there is no specific data provided on the combination of Duvelisib and Nivolumab for skin cancer in the information available.12345

What safety data is available for the combination of Duvelisib and Nivolumab in treating skin cancer?

The provided research does not directly address the safety data for the combination of Duvelisib and Nivolumab specifically for skin cancer. However, it includes information on the safety profile of Nivolumab, which is used in combination therapies. Nivolumab has been associated with adverse reactions such as fatigue, diarrhea, constipation, nausea, musculoskeletal pain, rash, and pruritus. Additionally, dermatological adverse events have been reported with Nivolumab in combination with other drugs, such as rash and pruritus. No specific safety data for Duvelisib or its combination with Nivolumab is mentioned in the provided research.678910

Is the drug Duvelisib, Nivolumab a promising treatment for skin cancer?

Yes, Nivolumab, which is part of the treatment, has shown promise in treating various cancers, including skin cancer. It works by helping the immune system fight cancer cells more effectively. In studies, it has improved survival rates and response in patients with advanced cancers.18111213

Research Team

NM

Neha Mehta-Shah

Principal Investigator

Yale University Cancer Center LAO

Eligibility Criteria

Adults over 18 with stage IIB-IVB mycosis fungoides or Sezary syndrome who've had prior systemic therapy can join this trial. They must have certain levels of blood cells, kidney and liver function, and controlled brain metastases if present. Heart disease patients need a specific risk assessment. Participants must use effective contraception and not be pregnant or breastfeeding.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.
I am 18 years old or older.
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) or =< 5 x institutional ULN if with history of Gilbert's syndrome
See 12 more

Exclusion Criteria

I do not have an active or history of severe autoimmune disease.
I have been treated with a PI3K inhibitor before.
I have previously been treated with drugs that boost the immune system.

Treatment Details

Interventions

  • Duvelisib (PI3K Inhibitor)
  • Nivolumab (Checkpoint Inhibitor)
Trial OverviewThe trial is testing the combination of duvelisib (which blocks enzymes for cell growth) with nivolumab (an immunotherapy that helps the immune system attack cancer). It aims to find the best dose, benefits, and side effects compared to usual treatments for these skin cancers.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (duvelisib, nivolumab)Experimental Treatment6 Interventions
Patients receive duvelisib PO QD or BID on days 1-28 or days 1-14 and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET-CT or CT scan at baseline. Patients also undergo punch biopsy and collection of blood samples throughout the trial.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

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 81 patients with unresectable locally advanced non-small cell lung cancer (NSCLC), those with high tumor mutational burden (TMB-high) showed significantly better outcomes, including lower local-regional failure rates (9% vs 51%) and improved progression-free survival (66% vs 27%) compared to TMB-low patients.
The study suggests that TMB status could be a valuable biomarker for personalizing treatment strategies, as it was the only factor significantly associated with local-regional failure and progression-free survival after treatment with chemoradiation and adjuvant durvalumab.
Analysis of Tumor Mutational Burden, Progression-Free Survival, and Local-Regional Control in Patents with Locally Advanced Non-Small Cell Lung Cancer Treated With Chemoradiation and Durvalumab.Lebow, ES., Shepherd, A., Eichholz, JE., et al.[2023]

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]
Analysis of Tumor Mutational Burden, Progression-Free Survival, and Local-Regional Control in Patents with Locally Advanced Non-Small Cell Lung Cancer Treated With Chemoradiation and Durvalumab. [2023]
Long-term survival with first-line nivolumab plus ipilimumab in patients with advanced non-small-cell lung cancer: a pooled analysis. [2023]
Phase I/II Trial of Immunotherapy With Durvalumab and Tremelimumab With Continuous or Intermittent MEK Inhibitor Selumetinib in NSCLC: Early Trial Report. [2021]
Dermatological adverse events associated with immune checkpoint inhibitor-based combinations of anticancer therapies: a systematic review. [2022]
FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. [2018]
[Treatment-related Skin Toxicity Caused by Programmed Death-1 Inhibitor Nivolumab: A Case Report]. [2020]
First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients. [2022]
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis. [2023]
Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]
Successful Treatment of Refractory Squamous Cell Cancer of the Head and Neck with Nivolumab and Ipilimumab. [2022]
Nivolumab-induced hypothyoidism with consequent hypothyroid related myopathy. [2020]