Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT04652960
Trial Phases:	Phase I	Protocol IDs:	10347 (primary) 10347 NCI-2020-11641
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Yale University Cancer Center LAO
NCI Full Details:	http://clinicaltrials.gov/show/NCT04652960

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.