Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652960
Status:
SUSPENDED
Last Update Posted:
2024-07-03
First Post:
2020-12-03
Brief Title:
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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:
SUSPENDED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other - Pending Amendment
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 andor 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 bodys 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 fungoidesSezary syndrome MFSS
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 fungoidesSezary syndrome MFSS
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:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA186689 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186689 |
| NCI-2020-11641 | REGISTRY | None | None |
| 10347 | OTHER | None | None |
| 10347 | OTHER | None | None |