Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
NCT ID: NCT04652960
Last Updated: 2025-11-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE1
Total Enrollment
38 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-10-21
Study Completion Date
2027-11-03
Brief Summary
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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
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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.
Conditions
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Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8
Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8
Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment (duvelisib, nivolumab)
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.
Group Type
EXPERIMENTAL
Biospecimen Collection
Intervention Type
PROCEDURE
Undergo collection of blood samples
Computed Tomography
Intervention Type
PROCEDURE
Undergo CT scan
Duvelisib
Intervention Type
DRUG
Given PO
Nivolumab
Intervention Type
BIOLOGICAL
Given IV
Positron Emission Tomography
Intervention Type
PROCEDURE
Undergo PET
Punch Biopsy
Intervention Type
PROCEDURE
Undergo punch biopsies
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Intervention Type
PROCEDURE
Computed Tomography
Undergo CT scan
Intervention Type
PROCEDURE
Duvelisib
Given PO
Intervention Type
DRUG
Nivolumab
Given IV
Intervention Type
BIOLOGICAL
Positron Emission Tomography
Undergo PET
Intervention Type
PROCEDURE
Punch Biopsy
Undergo punch biopsies
Intervention Type
PROCEDURE
Other Intervention Names
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Biological Sample Collection
Biospecimen Collected
Specimen Collection
CAT
CAT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized axial tomography (procedure)
Computerized Tomography
Computerized Tomography (CT) scan
CT
CT Scan
Diagnostic CAT Scan
Diagnostic CAT Scan Service Type
tomography
8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one
Copiktra
INK-1197
IPI 145
IPI-145
IPI145
ABP 206
BCD-263
BMS 936558
BMS-936558
BMS936558
CMAB819
MDX 1106
MDX-1106
MDX1106
NIVO
Nivolumab Biosimilar ABP 206
Nivolumab Biosimilar BCD-263
Nivolumab Biosimilar CMAB819
ONO 4538
ONO-4538
ONO4538
Opdivo
Medical Imaging, Positron Emission Tomography
PET
PET Scan
Positron emission tomography (procedure)
Positron Emission Tomography Scan
Positron-Emission Tomography
PT
BIOPSY, PUNCH
Punch Biopsy of Skin
Eligibility Criteria
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Inclusion Criteria
* Patients must have histologically or cytologically confirmed MF or SS, stages IIB to IVB with measurable disease and/or detectable blood involvement based on the Global Cutaneous Lymphoma Response Criteria
* Patients must have had at least one line of prior systemic therapy
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of duvelisib in combination with nivolumab in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%)
* Absolute neutrophil count \>= 1000/mcL
* Platelets \> 75,000/mcL
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) or =\< 5 x institutional ULN if with history of Gilbert's syndrome
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
* Creatinine =\< 2.0 x institutional ULN
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* The effects of nivolumab and duvelisib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of nivolumab and duvelisib. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 7 days prior to the start of nivolumab and duvelisib. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and duvelisib and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
* Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of administration of investigational agents on this study
* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with active cytomegalovirus (CMV) (positive serology for anti-CMV IgM antibody and negative for anti-CMV IgG antibody or positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy will be excluded from participation in the study. Carriers will be monitored per institutional guidelines
* Patients should be excluded if they have known active hepatitis B (e.g. hepatitis B virus \[HBV\] surface antigen \[HBsAg\] reactive) or hepatitis C (e.g. hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
* Patients with chronic HBV or HCV are defined as patients with positive hepatitis B serology: Patients with a negative HBsAg and a positive hepatitis B core antibody (HBcAb) require an undetectable/negative hepatitis B deoxyribonucleic acid (DNA) test (e.g. polymerase chain reaction \[PCR\] test) to be enrolled, and will require prophylactic antiviral treatment initiated prior to the first dose of study drug, and continued until approximately 6 to 12 months after completion of study drug(s)
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia and neuropathy
* Patients who are receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to duvelisib or nivolumab
* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible to start study therapy. Patients who are on strong inhibitors or inducers of CYP3A4 may start study therapy if discontinued 5 half lives before start of study therapy. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, congestive heart failure New York Heart Association (NYHA) grade \>= 3, unstable angina pectoris, and cardiac arrhythmia
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Baseline QT interval corrected with Fridericia's method (QTcF) \> 500 ms
* Note: Criteria does not apply to subjects with a right or left bundle branch block
* Pregnant women are excluded from this study because nivolumab and duvelisib have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab and duvelisib, breastfeeding should be discontinued if the mother is treated with nivolumab and duvelisib. These potential risks may also apply to other agents used in this study
* Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study
* Patients must have had at least one line of prior systemic therapy
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of duvelisib in combination with nivolumab in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%)
* Absolute neutrophil count \>= 1000/mcL
* Platelets \> 75,000/mcL
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) or =\< 5 x institutional ULN if with history of Gilbert's syndrome
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
* Creatinine =\< 2.0 x institutional ULN
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* The effects of nivolumab and duvelisib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of nivolumab and duvelisib. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 7 days prior to the start of nivolumab and duvelisib. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and duvelisib and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
* Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of administration of investigational agents on this study
* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with active cytomegalovirus (CMV) (positive serology for anti-CMV IgM antibody and negative for anti-CMV IgG antibody or positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy will be excluded from participation in the study. Carriers will be monitored per institutional guidelines
* Patients should be excluded if they have known active hepatitis B (e.g. hepatitis B virus \[HBV\] surface antigen \[HBsAg\] reactive) or hepatitis C (e.g. hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
* Patients with chronic HBV or HCV are defined as patients with positive hepatitis B serology: Patients with a negative HBsAg and a positive hepatitis B core antibody (HBcAb) require an undetectable/negative hepatitis B deoxyribonucleic acid (DNA) test (e.g. polymerase chain reaction \[PCR\] test) to be enrolled, and will require prophylactic antiviral treatment initiated prior to the first dose of study drug, and continued until approximately 6 to 12 months after completion of study drug(s)
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia and neuropathy
* Patients who are receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to duvelisib or nivolumab
* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible to start study therapy. Patients who are on strong inhibitors or inducers of CYP3A4 may start study therapy if discontinued 5 half lives before start of study therapy. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, congestive heart failure New York Heart Association (NYHA) grade \>= 3, unstable angina pectoris, and cardiac arrhythmia
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Baseline QT interval corrected with Fridericia's method (QTcF) \> 500 ms
* Note: Criteria does not apply to subjects with a right or left bundle branch block
* Pregnant women are excluded from this study because nivolumab and duvelisib have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab and duvelisib, breastfeeding should be discontinued if the mother is treated with nivolumab and duvelisib. These potential risks may also apply to other agents used in this study
* Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study
Exclusion Criteria
* Prior therapy with a PI3K inhibitor
* Prior therapy with nivolumab or other agents targeting T-cell co-stimulation or checkpoint pathways
* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
* Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
* Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of study drug administration. Inhaled or topical steroids, steroids for physiologic or adrenal replacement doses =\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
* History of tuberculosis treatment within the 2 years prior to enrollment
* Ongoing treatment with other immunosuppressive agent including, but not limited to, methotrexate, azathioprine, anti-tumor necrosis factor (TNF) agents, etc. with the exception of steroids
* Administration of a live or live attenuated vaccine within 6 weeks of initiation of study therapy
* Ongoing treatment with systemic steroids at dose equivalent to greater than prednisone 10 mg daily or other immunosuppressive medication within 7 days of initiation of study therapy
* Inhaled steroids will be permitted
* Topical steroids for cutaneous manifestations of MF/SS will be permitted below:
* Continued use of select concomitant topical steroids is permitted if the patient has remained clinically stable for at least 4 weeks.
* Patients who are on low or moderate potency topical corticosteroids may participate if they are on a stable dose for at least 4 weeks before enrollment. Local injections of corticosteroids are acceptable; all corticosteroids will be reported as concomitant medications.
* Patients prescribed prednisone 10 mg PO daily or less (or equivalent) will not be excluded
* Concomitant use of another systemic therapy for MF/SS. Patients must have the following minimum wash-out from previous treatments:
* At least 8 weeks for low-dose (12 Gy or less) total skin electron beam therapy (TSEBT)
* At least 4 weeks for systemic cytotoxic anticancer agents or for tumor-targeting monoclonal antibodies (mAbs), with the exception of alemtuzumab, for which the washout is at least 16 weeks
* At least 2 weeks or 5 half-lives for systemic retinoids, interferons, vorinostat, romidepsin, and denileukin diftitox, or anticancer investigational agents that are not defined as immunotherapy
* At least 2 weeks for local radiation therapy
* At least 1 week for topical retinoids, nitrogen mustard, or imiquimod
* Concomitant malignancy requiring active systemic therapy, excluding adjuvant endocrine therapy with the following exceptions:
* Patients with non-melanoma skin cancer or carcinoma in situ of the cervix will not be excluded
* Adjuvant or maintenance therapy to reduce the risk of recurrence of another malignancy (excluding cutaneous T-cell lymphoma) is permissible after discussion with the Washington University principal investigator
* Subjects with previous malignancies are eligible if disease-free for \> 2 years
* History of solid organ transplantation or allogeneic bone marrow transplantation
* Prior therapy with nivolumab or other agents targeting T-cell co-stimulation or checkpoint pathways
* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
* Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
* Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of study drug administration. Inhaled or topical steroids, steroids for physiologic or adrenal replacement doses =\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
* History of tuberculosis treatment within the 2 years prior to enrollment
* Ongoing treatment with other immunosuppressive agent including, but not limited to, methotrexate, azathioprine, anti-tumor necrosis factor (TNF) agents, etc. with the exception of steroids
* Administration of a live or live attenuated vaccine within 6 weeks of initiation of study therapy
* Ongoing treatment with systemic steroids at dose equivalent to greater than prednisone 10 mg daily or other immunosuppressive medication within 7 days of initiation of study therapy
* Inhaled steroids will be permitted
* Topical steroids for cutaneous manifestations of MF/SS will be permitted below:
* Continued use of select concomitant topical steroids is permitted if the patient has remained clinically stable for at least 4 weeks.
* Patients who are on low or moderate potency topical corticosteroids may participate if they are on a stable dose for at least 4 weeks before enrollment. Local injections of corticosteroids are acceptable; all corticosteroids will be reported as concomitant medications.
* Patients prescribed prednisone 10 mg PO daily or less (or equivalent) will not be excluded
* Concomitant use of another systemic therapy for MF/SS. Patients must have the following minimum wash-out from previous treatments:
* At least 8 weeks for low-dose (12 Gy or less) total skin electron beam therapy (TSEBT)
* At least 4 weeks for systemic cytotoxic anticancer agents or for tumor-targeting monoclonal antibodies (mAbs), with the exception of alemtuzumab, for which the washout is at least 16 weeks
* At least 2 weeks or 5 half-lives for systemic retinoids, interferons, vorinostat, romidepsin, and denileukin diftitox, or anticancer investigational agents that are not defined as immunotherapy
* At least 2 weeks for local radiation therapy
* At least 1 week for topical retinoids, nitrogen mustard, or imiquimod
* Concomitant malignancy requiring active systemic therapy, excluding adjuvant endocrine therapy with the following exceptions:
* Patients with non-melanoma skin cancer or carcinoma in situ of the cervix will not be excluded
* Adjuvant or maintenance therapy to reduce the risk of recurrence of another malignancy (excluding cutaneous T-cell lymphoma) is permissible after discussion with the Washington University principal investigator
* Subjects with previous malignancies are eligible if disease-free for \> 2 years
* History of solid organ transplantation or allogeneic bone marrow transplantation
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Neha Mehta-Shah
Role: PRINCIPAL_INVESTIGATOR
Yale University Cancer Center LAO
Locations
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Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Site Status
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Site Status
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Site Status
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Site Status
Mayo Clinic in Florida
Jacksonville, Florida, United States
Site Status
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Site Status
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Site Status
Northwestern University
Chicago, Illinois, United States
Site Status
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Site Status
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Site Status
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Site Status
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Siteman Cancer Center-South County
St Louis, Missouri, United States
Site Status
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Site Status
NYP/Weill Cornell Medical Center
New York, New York, United States
Site Status
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2020-11641
Identifier Type: REGISTRY
Identifier Source: secondary_id
10347
Identifier Type: OTHER
Identifier Source: secondary_id
10347
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2020-11641
Identifier Type: -
Identifier Source: org_study_id