8 Participants Needed

DEC-C + Nivolumab for Melanoma

MB
TM
Overseen ByTessa McSpadden
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

Activation of the RIG-I innate immune pathway and increased expression of tumor antigens and pro-immune genes by DEC-C during Nivolumab treatment may enhance the frequency and activity of anti-tumor immune cells (CD4+ and CD8+ T-cells, NK cells) and reduce the frequency and activity of immunosuppressive cells. This may increase the overall effectiveness and success of Nivolumab treatment. This pilot clinical trial will demonstrate whether combinatorial immunotherapeutic approaches that target epigenetic immune repression and RIG-I activity can favorably alter the tumor immune cell microenvironment and benefit patients with mucosal melanoma.

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 cannot be on drugs metabolized by CDA or on immunosuppressive therapy with more than 10mg/day of prednisone within 14 days of enrollment.

Is the combination of DEC-C and Nivolumab safe for humans?

Nivolumab, also known as Opdivo, is generally considered safe for humans, but it can cause side effects like fatigue, diarrhea, and skin rash. It may also lead to more serious immune-related side effects, such as inflammation of the liver or lungs. While DEC-C (Oral Decitabine/Cedazuridine) is not specifically mentioned, the safety of Nivolumab has been evaluated in various conditions, including melanoma.12345

What makes the drug DEC-C + Nivolumab unique for treating melanoma?

DEC-C + Nivolumab is unique because it combines an oral form of decitabine with cedazuridine, which helps increase the effectiveness of decitabine, with Nivolumab, an intravenous drug that blocks a protein called PD-1, allowing the immune system to better attack melanoma cells. This combination offers a novel approach by integrating an oral component with an established immune checkpoint inhibitor.678910

What data supports the effectiveness of the drug combination DEC-C and Nivolumab for treating melanoma?

Nivolumab has shown a long-term survival benefit for patients with advanced melanoma, and decitabine has been studied for its potential to make melanoma cells more sensitive to immune responses. This suggests that combining these drugs might help in treating melanoma by enhancing the immune system's ability to fight the cancer.611121314

Who Is on the Research Team?

MM

Martin McCarter

Principal Investigator

Colorado Research Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-100 with advanced mucosal melanoma, who may have had prior immune therapy. They must be able to undergo biopsies, have good organ function, and not be pregnant or breastfeeding. Participants need a negative pregnancy test and agree to use contraception if applicable. HIV-positive individuals can join if they meet certain conditions.

Inclusion Criteria

Women of childbearing potential must have a negative pregnancy test and agree to use effective contraceptive method
Patients must be willing to have archived tumor specimens utilized for correlative studies
My kidney function is normal.
See 11 more

Exclusion Criteria

I have cancer that has spread to the lining of my brain and spinal cord.
I do not have an active Hepatitis B or C infection.
I don't have any health issues that could affect the trial's results.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ib Treatment

Participants receive DEC-C and Nivolumab to assess the RP2D using a TITE-BOIN design

Estimated 6-12 weeks

Phase II Treatment

Evaluate efficacy and safety of DEC-C and Nivolumab at the RP2D

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nivolumab
  • Oral Decitabine/Cedazuridine (DEC-C)
Trial Overview The study tests Oral Decitabine/Cedazuridine (DEC-C) combined with Nivolumab in patients with mucosal melanoma. It aims to see if DEC-C can boost the body's immune response against cancer by activating specific pathways and increasing tumor-fighting cells while on Nivolumab treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Oral Decitabine/Cedazuridine (DEC-C) and Nivolumab in Mucosal MelanomaExperimental Treatment1 Intervention

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

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Approved in United States as Opdivo for:
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Approved in European Union as Opdivo for:
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Approved in Canada as Opdivo for:
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Approved in Switzerland as Opdivo for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Comprehensive Cancer Network

Collaborator

Trials
121
Recruited
7,400+

Taiho Oncology, Inc.

Industry Sponsor

Trials
79
Recruited
12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

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]
A retrospective analysis of adverse events related to PD-1/PD-L1 inhibitors revealed a significant association between Pembrolizumab and hepatitis B reactivation (HBVr), with a reporting odds ratio of 2.32, indicating a higher risk compared to other treatments.
No cases of HBVr were reported with Ipilimumab or Avelumab, suggesting that not all immune checkpoint inhibitors carry the same risk, highlighting the need for further prospective studies to confirm these findings.
Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors.Burns, EA., Muhsen, IN., Anand, K., et al.[2023]
Pembrolizumab, an anti-PD-1 antibody, has shown significant efficacy in treating advanced melanoma, demonstrating superior progression-free survival compared to chemotherapy in Phase II trials and improved overall survival in Phase III trials.
The treatment is generally well tolerated with a favorable safety profile, though common side effects include fatigue and rash, while less frequent but serious immune-related adverse events can occur.
Pembrolizumab in the management of metastatic melanoma.Spain, L., Younger, E., Hatipoglu, E., et al.[2020]

Citations

For Whom the Bell Tolls? A Toll-Like Receptor 9 Agonist's Journey from Vaccine Adjuvant to Promising Agent in Anti-PD-1-Resistant Melanoma. [2022]
The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England. [2020]
Pilot early phase II study of decitabine and carboplatin in patients with advanced melanoma. [2022]
Pharmaceutical approval update. [2020]
Decitabine up-regulates S100A2 expression and synergizes with IFN-gamma to kill uveal melanoma cells. [2018]
Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors. [2023]
Pembrolizumab in the management of metastatic melanoma. [2020]
FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. [2018]
Real-world Outcomes of Ipilimumab Plus Nivolumab Combination Therapy in a Nation-wide Cohort of Advanced Melanoma Patients in the Netherlands. [2023]
Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. [2022]
An update on the pharmacodynamics, pharmacokinetics, safety and clinical efficacy of nivolumab in the treatment of solid cancers. [2018]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Nivolumab: a review of its use in patients with malignant melanoma. [2021]
Effects of nivolumab in peritoneal carcinamatosis of malign melanoma in mouse model. [2018]
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