Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT04652960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2020-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Study With an Expansion Cohort of Duvelisib and Nivolumab in Mycosis Fungoides (MF) and Sézary Syndrome (SS)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in patients with mycosis fungoides and Sezary syndrome.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the recommended phase II dose (RP2D) or maximum tolerated dose (MTD) of the combination of duvelisib with nivolumab in patients with advanced mycosis fungoides/Sezary syndrome (MF/SS).
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. Ia. To determine the overall response rate at four months to the combination of nivolumab and duvelisib.
Ib. To determine the time to maximum response, best overall response rate, complete remission rate, and duration of response among responding patients.
EXPLORATORY OBJECTIVES:
I. To evaluate whether intra-patient changes in serum cytokines (soluble CD40L, TNF-beta, IL-17alpha, IL-15, CXCL13, IL-12p40) predict response to duvelisib in combination with nivolumab in cutaneous T-cell lymphoma (CTCL).
II. To explore whether the combination of duvelisib and nivolumab changes the T-cell repertoire including T-cell receptor sequencing pre- and post- treatment with duvelisib and nivolumab in effort to better understand skin flare and other immunogenic reactions to this combination therapy.
OUTLINE: This is a dose-escalation study of duvelisib in combination with fixed dose nivolumab followed by a dose-expansion study.
Patients receive duvelisib orally (PO) once daily (QD) or twice daily (BID) on days 1-28 or days 1-14 and nivolumab intravenously (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 positron emission tomography (PET)-computed tomography (CT) or CT scan at baseline. Patients also undergo punch biopsy and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up every 6 months for 2 years.
I. To determine the recommended phase II dose (RP2D) or maximum tolerated dose (MTD) of the combination of duvelisib with nivolumab in patients with advanced mycosis fungoides/Sezary syndrome (MF/SS).
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. Ia. To determine the overall response rate at four months to the combination of nivolumab and duvelisib.
Ib. To determine the time to maximum response, best overall response rate, complete remission rate, and duration of response among responding patients.
EXPLORATORY OBJECTIVES:
I. To evaluate whether intra-patient changes in serum cytokines (soluble CD40L, TNF-beta, IL-17alpha, IL-15, CXCL13, IL-12p40) predict response to duvelisib in combination with nivolumab in cutaneous T-cell lymphoma (CTCL).
II. To explore whether the combination of duvelisib and nivolumab changes the T-cell repertoire including T-cell receptor sequencing pre- and post- treatment with duvelisib and nivolumab in effort to better understand skin flare and other immunogenic reactions to this combination therapy.
OUTLINE: This is a dose-escalation study of duvelisib in combination with fixed dose nivolumab followed by a dose-expansion study.
Patients receive duvelisib orally (PO) once daily (QD) or twice daily (BID) on days 1-28 or days 1-14 and nivolumab intravenously (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 positron emission tomography (PET)-computed tomography (CT) or CT scan at baseline. Patients also undergo punch biopsy and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-11641 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 10347 | OTHER | Yale University Cancer Center LAO | View | |
| 10347 | OTHER | CTEP | View | |
| UM1CA186689 | NIH | None | https://reporter.nih.gov/quic… | View |