Ipilimumab or Nivolumab in Treating Patients With Relapsed Hematologic Malignancies After Donor Stem Cell Transplant
NCT ID: NCT01822509
Last Updated: 2021-06-24
Study Results
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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COMPLETED
PHASE1
71 participants
INTERVENTIONAL
2013-05-16
2021-06-10
Brief Summary
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Detailed Description
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I. To determine the maximum-tolerated dose (MTD) of ipilimumab or nivolumab administered to patients with relapsed hematologic malignancies following allogeneic stem cell transplantation. (Phase I) II. To characterize the toxicity of ipilimumab or nivolumab administered at the MTD in this patient population. (Phase Ib)
SECONDARY OBJECTIVES:
I. To assess response rate. II. To assess progression free and overall survival.
EXPLORATORY OBJECTIVE:
I. To assess the phenotypic and functional effects of ipilimumab or nivolumab on immune cells.
OUTLINE: This is a dose-escalation study.
INDUCTION PHASE: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 12 weeks beginning at cycle 5 (24 weeks after the first dose of ipilimumab) for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving clinical benefit will have the option to continue with ongoing maintenance dosing every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Treatment repeats every 14 days for up to a total of 60 weeks (including Induction) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (ipilimumab, nivolumab)
See Detailed Description.
Ipilimumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Nivolumab
Given IV
Interventions
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Ipilimumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Nivolumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The following malignancies will be considered eligible if progressive or persistent:
* Chronic lymphocytic leukemia (CLL)
* Non-Hodgkin lymphoma (NHL)
* Hodgkin lymphoma (HL)
* Multiple myeloma (MM)
* Acute leukemia (acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\])
* Myelodysplastic syndrome (MDS)
* Myeloproliferative neoplasms (MPN)
* Chronic myeloid leukemia (CML)
* Life expectancy of greater than 3 months
* Must have undergone allogeneic hematopoietic stem cell transplantation (HSCT) (regardless of stem cell source)
* Must have baseline donor T cell chimerism of \>= 20%
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (unless due to Gilbert's disease or disease-related hemolysis, then =\< 3.0 x ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN
* Creatinine =\< 1.5 x institutional ULN
* Prednisone dose =\< 5 mg/day and off all other systemic immunosuppressive medications for at least 4 weeks prior to study entry
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Patients with prior history of or active severe (grade 3 or 4) acute graft-versus-host disease (GVHD)
* Patients with a history of prior treatment with ipilimumab, anti-programmed cell death protein 1 (PD 1) antibody, or cluster of differentiation (CD)137 agonist therapy are ineligible for the ipilimumab arm, but are eligible for the nivolumab arm
* Patients who have had donor lymphocyte infusion (DLI) within 8 weeks prior to registration
* Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis); patients with Hashimoto's thyroiditis are eligible to go on study
* Patients with known chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections should be excluded
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study because ipilimumab and nivolumab are immunomodulatory agents with the potential for teratogenic or abortifacient effects; the effects of ipilimumab and nivolumab on the developing human fetus are unknown; for this reason and because immunomodulatory agents are known to be teratogenic, women of child-bearing potential 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; should a woman become pregnant or suspect she is pregnant while participating in this study or within 23 weeks after the last dose of study drug, 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 for at least 31 weeks after completion of ipilimumab or nivolumab administration
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Matthew S Davids
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Countries
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References
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Penter L, Zhang Y, Savell A, Huang T, Cieri N, Thrash EM, Kim-Schulze S, Jhaveri A, Fu J, Ranasinghe S, Li S, Zhang W, Hathaway ES, Nazzaro M, Kim HT, Chen H, Thurin M, Rodig SJ, Severgnini M, Cibulskis C, Gabriel S, Livak KJ, Cutler C, Antin JH, Nikiforow S, Koreth J, Ho VT, Armand P, Ritz J, Streicher H, Neuberg D, Hodi FS, Gnjatic S, Soiffer RJ, Liu XS, Davids MS, Bachireddy P, Wu CJ. Molecular and cellular features of CTLA-4 blockade for relapsed myeloid malignancies after transplantation. Blood. 2021 Jun 10;137(23):3212-3217. doi: 10.1182/blood.2021010867.
Davids MS, Kim HT, Costello C, Herrera AF, Locke FL, Maegawa RO, Savell A, Mazzeo M, Anderson A, Boardman AP, Weber A, Avigan D, Chen YB, Nikiforow S, Ho VT, Cutler C, Alyea EP, Bachireddy P, Wu CJ, Ritz J, Streicher H, Ball ED, Bashey A, Soiffer RJ, Armand P. A multicenter phase 1 study of nivolumab for relapsed hematologic malignancies after allogeneic transplantation. Blood. 2020 Jun 11;135(24):2182-2191. doi: 10.1182/blood.2019004710.
Davids MS, Kim HT, Bachireddy P, Costello C, Liguori R, Savell A, Lukez AP, Avigan D, Chen YB, McSweeney P, LeBoeuf NR, Rooney MS, Bowden M, Zhou CW, Granter SR, Hornick JL, Rodig SJ, Hirakawa M, Severgnini M, Hodi FS, Wu CJ, Ho VT, Cutler C, Koreth J, Alyea EP, Antin JH, Armand P, Streicher H, Ball ED, Ritz J, Bashey A, Soiffer RJ; Leukemia and Lymphoma Society Blood Cancer Research Partnership. Ipilimumab for Patients with Relapse after Allogeneic Transplantation. N Engl J Med. 2016 Jul 14;375(2):143-53. doi: 10.1056/NEJMoa1601202.
Other Identifiers
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NCI-2013-00739
Identifier Type: REGISTRY
Identifier Source: secondary_id
12-537
Identifier Type: -
Identifier Source: secondary_id
9204
Identifier Type: OTHER
Identifier Source: secondary_id
9204
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2013-00739
Identifier Type: -
Identifier Source: org_study_id
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