Clinical Trials /

Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

NCT02408861

Description:

This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment, or solid tumors that have spread to other places in the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ipilimumab is an antibody that acts against a molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of your immune system by shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV associated classical Hodgkin lymphoma or solid tumors compared to ipilimumab with nivolumab alone.

Related Conditions:
  • Classical Hodgkin Lymphoma
  • Colorectal Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
  • Official Title: A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV-Associated Solid Tumors With Expansion Cohorts in HIV-Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: NCI-2015-00461
  • SECONDARY ID: NCI-2015-00461
  • SECONDARY ID: PAMC-095_R03PAPP01
  • SECONDARY ID: AMC-095
  • SECONDARY ID: AMC-095
  • SECONDARY ID: AMC-095
  • SECONDARY ID: U01CA121947
  • SECONDARY ID: UM1CA121947
  • NCT ID: NCT02408861

Conditions

  • Advanced Malignant Solid Neoplasm
  • Anal Carcinoma
  • HIV Infection
  • Kaposi Sarcoma
  • Lung Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Classic Hodgkin Lymphoma
  • Refractory Classic Hodgkin Lymphoma
  • Unresectable Solid Neoplasm

Interventions

DrugSynonymsArms
IpilimumabAnti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4, YervoyTreatment (nivolumab, ipilimumab)
NivolumabBMS-936558, MDX-1106, NIVO, ONO-4538, OpdivoTreatment (nivolumab, ipilimumab)

Purpose

This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment, or solid tumors that have spread to other places in the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ipilimumab is an antibody that acts against a molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of your immune system by shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV associated classical Hodgkin lymphoma or solid tumors compared to ipilimumab with nivolumab alone.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To demonstrate safety and feasibility of ipilimumab and nivolumab at the standard doses of
      drug in solid tumor and relapsed refractory HIV-classical Hodgkin lymphoma (cHL) participants
      with human immunodeficiency virus (HIV) infection given the possibility of increased toxicity
      based on immune activation, co-morbidity, or interference with highly active antiretroviral
      therapy (HAART) therapy. (Dose De-escalation and Dose Expansion Cohorts)

      SECONDARY OBJECTIVES:

      I. To evaluate the effects of single agent nivolumab, and the combination of ipilimumab and
      nivolumab, on immune function (HIV viral load in plasma using conventional assay, CD4+ and
      CD8+ cells). (Dose De-escalation Cohort) II. To preliminarily assess objective response rates
      associated with treatment for commonly represented solid tumors (Kaposi sarcoma, anal cancer,
      and lung cancer) and relapsed refractory HIV-cHL. (Solid Tumor Dose Expansion and cHL
      Cohorts) III. To evaluate the effects of single agent nivolumab, and the combination of
      ipilimumab and nivolumab, on immune function (HIV viral load in plasma using conventional HIV
      assay, CD4+, and CD8+ cells). (Solid Tumor Dose Expansion and cHL Cohorts)

      EXPLORATORY OBJECTIVES:

      I. Understand the immune response to agent in the context of antiretroviral therapy (ART), of
      altered immune function, and repertoire due to prior HIV infection.

      Ia. To evaluate the effects of single agent nivolumab, and the combination of ipilimumab and
      nivolumab, on intratumor immune cells by immunohistochemistry (IHC) such as PD1, programmed
      cell death 1 ligand 1 (PDL-1), and others.

      Ib. To evaluate the effects of single agent nivolumab, and the combination of ipilimumab and
      nivolumab on circulating cytokine markers by multiplex assay, such as: interleukin (IL)-2,
      IL-4, IL-6, IL-10, IL-8, interferon gamma-induced protein 10 (IP10), chemokine (C-X-C motif)
      ligand 13 (CXCL13), interferon (IFN)-gamma, tumor necrosis factor (TNF)-alpha, soluble IL-2
      receptor (sIL2R)-alpha, sCD27, soluble TNF receptor (sTNFR)1, and sTNFR2.

      II. To understand the response of human tumor viruses (human papillomavirus [HPV],
      Epstein-Barr virus [EBV], Kaposi's sarcoma-associated herpesvirus [KSHV]) to agent.

      IIa. To evaluate the effects of single agent nivolumab, and the combination of ipilimumab and
      nivolumab on herpesvirus loads (EBV, KSHV, cytomegalovirus [CMV]) in plasma.

      IIb. To evaluate the effects of single agent nivolumab, and the combination of ipilimumab and
      nivolumab on latent herpesvirus (EBV, KSHV, CMV) in peripheral blood mononuclear cells
      (PBMC).

      IIc. To evaluate the effects of single agent nivolumab, and the combination of ipilimumab and
      nivolumab on herpesvirus specific CD8 and CD4 T cells in PBMC.

      IId. In cases of Kaposi sarcoma, to evaluate the effects of single agent nivolumab, and the
      combination of ipilimumab and nivolumab on viral transcription in tumor biopsies.

      IIe. In cases of anal cancer, to evaluate the effects of single agent nivolumab, and the
      combination of ipilimumab and nivolumab on HPV types in anal swabs, when feasible.

      III. Understand the response of HIV to agent. IIIa. To evaluate the effects of single agent
      nivolumab, and the combination of ipilimumab and nivolumab on latent HIV loads in PBMC using
      outgrowth assay.

      IIIb. To evaluate the effects of single agent nivolumab, and the combination of ipilimumab
      and nivolumab on HIV reactive T cells.

      OUTLINE: This is a dose-escalation study of nivolumab.

      Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Patients in dose
      level 2 also receive ipilimumab IV over 90 minutes on day 1 of every third cycle of
      nivolumab, and patients in dose level -2 also receive ipilimumab IV over 90 minutes on day 1
      of every sixth cycle of nivolumab. Cycles repeat every 14 days for up to 46 cycles of
      nivolumab (with ipilimumab if receiving dose level 2 or -2) in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 16 weeks or 112 days (based
      on 5 half lives).
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (nivolumab, ipilimumab)ExperimentalPatients receive nivolumab IV over 30 minutes on day 1. Patients in dose level 2 also receive ipilimumab IV over 90 minutes on day 1 of every third cycle of nivolumab, and patients in dose level -2 also receive ipilimumab IV over 90 minutes on day 1 of every sixth cycle of nivolumab. Cycles repeat every 14 days for up to 46 cycles of nivolumab (with ipilimumab if receiving dose level 2 or -2) in the absence of disease progression or unacceptable toxicity.
  • Ipilimumab
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have histologically confirmed solid tumor malignancy that is
             metastatic or unresectable and for which standard curative or palliative measures do
             not exist or are no longer effective; participants with uncontrolled Kaposi sarcoma
             are permitted (KS must be increasing despite HAART and HIV suppression for greater
             than or equal to 2 months, or stable KS despite HAART for greater than or equal to 3
             months)

               -  For participants in the 24 participant solid tumor cohort, only those histologies
                  not known to respond to single agent nivolumab (such as pancreas, prostate, and
                  microsatellite stable [MSS] colorectal cancer) will be excluded

               -  For participants in the relapsed refractory HIV-cHL expansion cohort,
                  participants must have histologically confirmed, relapsed/refractory (defined as
                  relapsed/refractory to one or greater lines of therapy) HIV-associated classical
                  Hodgkin lymphoma

          -  HIV-1 infection, as documented by any federally approved, licensed HIV rapid test
             performed in conjunction with screening (or enzyme linked immunosorbent assay [ELISA],
             test kit, and confirmed by Western blot or other approved test); alternatively, this
             documentation may include a record demonstrating that another physician has documented
             the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the
             referring physician's written record that HIV infection was documented, with
             supporting information on the participant's relevant medical history and/or current
             management of HIV infection

          -  Participants must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded for
             non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional
             techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic
             resonance imaging (MRI), or calipers by clinical exam; scans must have been performed
             within 4 weeks prior to registration; Note: for participants with Kaposi sarcoma, the
             following apply: at least five measurable cutaneous KS lesions or any number of
             lesions with systemic unresectable disease with no previous local radiation, surgical,
             or intralesional cytotoxic therapy that would prevent response assessment

          -  Prior therapy for metastatic disease permitted; at least 4 weeks must have elapsed
             since prior chemotherapy or biological therapy, 6 weeks if the regimen included
             carmustine (BCNU) or mitomycin C; radiotherapy must be completed at least 4 weeks
             prior to registration

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Leukocytes >= 2,000/mm^3
             (within 2 weeks prior to enrollment)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Absolute neutrophil count
             >= 1,000/mm^3 (within 2 weeks prior to enrollment)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Platelets >= 75,000/mm^3
             (within 2 weeks prior to enrollment)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin =< 1.5 x
             institutional upper limit of normal (ULN) =< 3 x ULN for subjects with Gilbert's
             disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia
             without aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation
             and must have a total bilirubin less than 3.0 mg/dL (within 2 weeks prior to
             enrollment)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum lipase and amylase <
             1.5 x ULN (within 2 weeks prior to enrollment)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: AST (serum glutamic
             oxaloacetic transaminase [SGOT])/ALT (serum glutamate pyruvate transaminase [SGPT]) =<
             3 x ULN (within 2 weeks prior to enrollment)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Creatinine < 1.5 UNL or
             creatinine clearance (CrCl) > 50 ml/min (within 2 weeks prior to enrollment)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Hemoglobin >= 9 g/dL
             (within 2 weeks prior to enrollment)

          -  PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum albumin >= 2.8 g/dL
             (within 2 weeks prior to enrollment)

          -  PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Leukocyte count: no lower limit
             (within 2 weeks prior to enrollment) (participants may receive granulocyte colony
             stimulating factor [GCSF] and transfusions to meet these parameters)

          -  PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Absolute neutrophil count: >=
             1,000/mm^3, unless decreased due to bone marrow involvement with lymphoma (within 2
             weeks prior to enrollment) (participants may receive GCSF and transfusions to meet
             these parameters)

          -  PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Platelets: >= 75,000/mm^3,
             unless decreased due to bone marrow involvement with lymphoma (within 2 weeks prior to
             enrollment) (participants may receive GCSF and transfusions to meet these parameters)

          -  PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Hemoglobin: >= 9 g/dL unless
             bone marrow involvement secondary to Hodgkin lymphoma is present (within 2 weeks prior
             to enrollment) (participants may receive GCSF and transfusions to meet these
             parameters)

          -  PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin: =<1.5 x
             institutional upper limit of normal (ULN), or =< 3 x ULN for participants with
             Gilbert's disease or with atazanavir- or indinavir-induced unconjugated
             hyperbilirubinemia without AST or ALT elevation, and must have a total bilirubin less
             than 3.0 mg/dL) (within 2 weeks prior to enrollment) (participants may receive GCSF
             and transfusions to meet these parameters)

          -  PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Serum lipase and amylase < 1.5
             x ULN (within 2 weeks prior to enrollment) (participants may receive GCSF and
             transfusions to meet these parameters)

          -  PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: AST (SGOT)/ALT (SGPT): =< 3 x
             ULN (within 2 weeks prior to enrollment) (participants may receive GCSF and
             transfusions to meet these parameters)

          -  PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Creatinine: < 1.5 x upper
             normal limit (UNL) or CrCl > 50ml/min (within 2 weeks prior to enrollment)
             (participants may receive GCSF and transfusions to meet these parameters)

          -  HIV viral load should be well suppressed, defined as below the limit of detection of
             the local assay or below 75 copies/mL by Food and Drug Administration (FDA)-approved
             assays, within 4 weeks prior to registration

          -  CD4 counts:

               -  For Stratum 1: CD4+ cell count greater than 200 cells/mm^3 obtained within 2
                  weeks prior to enrollment at any United States (U.S.) laboratory that has a
                  clinical laboratory improvement amendments (CLIA) certification or its equivalent

               -  For Stratum 2: CD4 cell count between 100-200 cells/mm^3 obtained within 2 weeks
                  prior to enrollment at any U.S. laboratory that has a clinical laboratory
                  improvement amendments (CLIA) certification or its equivalent

               -  Expansion Cohort: CD4 cell count for this cohort will be specified once Stratum 1
                  and Stratum 2 have completed enrollment

               -  Solid Tumor Expansion Cohort: CD4+ cell count greater than 200 cells/mm^3
                  obtained within 2 weeks prior to enrollment at any U.S. laboratory that has a
                  clinical laboratory improvement amendments (CLIA) certification or its equivalent

               -  cHL Cohort: CD4 cell count of at least 100 cells/mm^3

          -  Participants must be purified protein derivative (PPD) negative; alternatively, the
             QuantiFERON-tuberculosis (TB) Gold In-Tube (QFT-GIT) assay can be used; an individual
             is considered positive for M. tuberculosis infection if the IFN-gamma response to TB
             antigens is above the test cut-off (after subtracting the background IFN-gamma
             response in the negative control); the result must be obtained within 12 weeks prior
             to enrollment; PPD positive (or Quantiferon assay positive) participants are permitted
             if prophylaxis has been completed prior to enrollment

          -  The effects of nivolumab and ipilimumab 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 childbearing 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 6 months after the last dose of investigational
             drug; women of childbearing potential must have a negative serum or urine pregnancy
             test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic
             [HCG]) within 72 hours prior enrollment and the start of nivolumab; 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 who
             are sexually active with WOCBP will be instructed to adhere to contraception for a
             period of 31 weeks 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 receiving nivolumab will be
             instructed to adhere to contraception for a period of 6 months after the last dose of
             investigational product; men receiving nivolumab and who are sexually active with
             WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the
             last dose of investigational product; should a woman become pregnant or suspect she is
             pregnant while she or her partner is participating in this study, she (or the
             participating partner) should inform the treating physician immediately

          -  Participants MUST receive appropriate care and treatment for HIV infection, including
             antiretroviral medications when clinically indicated, and should be under the care of
             a physician experienced in HIV management; participants will be eligible regardless of
             antiretroviral medication (including no antiretroviral medication) provided there is
             no intention to initiate therapy or the regimen has been stable for at least 4 weeks
             with no intention to change the regimen within 12 weeks following enrollment

          -  Participants who have hepatitis C (both reactive anti-hepatitis C virus [HCV] antibody
             and detectable HCV ribonucleic acid [RNA]) and hepatitis B (hepatitis B surface
             antigen [HBsAg] positive and anti-hepatitis B core [HBc]-total positive), may be
             enrolled, provided total bilirubin is =< 1.5 x institutional ULN, and AST (SGOT) and
             ALT (SGPT) must be =< 3 X institutional upper limit of normal, and hepatitis B virus
             (HBV) deoxyribonucleic acid (DNA) < 100 IU/mL (if hepatitis B positive) within 2 weeks
             prior to enrollment

          -  Ability to understand and to sign a written informed consent document

          -  Criteria for Solid Tumor Expansion and Lymphoma Cohorts:

               -  Inclusion and exclusion criteria for this cohort are the same as above, with the
                  following rule for CD4 count based on tolerability in Phase I; if, participants
                  with lymphocyte T CD4 count between 100-200/mm^3 (Stratum 2) are shown to
                  tolerate treatment in the Phase I dose de-escalation portion at the same dose
                  level as those with CD4 counts > 200/mm^3 (Stratum 1), participants in the
                  expansion cohort with CD4 counts >= 100/mm^3 are permitted; otherwise, the
                  expansion is open to all solid tumor patients except those whose tumors are known
                  not to respond to nivolumab (pancreas, prostate and MSS colon cancer); for the
                  relapsed refractory HIV-cHL cohort, participants with CD4 count >= 100/mm^3 are
                  permitted

        Exclusion Criteria:

          -  Participants who have received any other investigational agents within the 4 weeks
             prior to enrollment; concurrent radiation therapy is not permitted, except palliative
             (limited-field) radiation therapy, if all of the following criteria are met:

               -  Repeat imaging demonstrates no new sites of bone metastases

               -  The lesion being considered for palliative radiation is not a target lesion

          -  Participants with known brain metastases or leptomeningeal metastases must be excluded
             unless they qualify for enrollment as described below because of poor prognosis and
             concerns regarding progressive neurologic dysfunction that would confound the
             evaluation of neurologic and other adverse events; participants with brain metastases
             are permitted if metastases have been treated and there is no magnetic resonance
             imaging (MRI) evidence of progression for at least 4 weeks or more after treatment is
             complete and within 4 weeks prior to the first dose of nivolumab administration

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ipilimumab, nivolumab, or other agents used in study, or history of
             severe hypersensitivity reaction to any monoclonal antibody

          -  Participants should be excluded if they have a condition requiring systemic treatment
             with either corticosteroids (> 10 mg daily prednisone equivalents) or other
             immunosuppressive medications within 2 weeks of study drug administration; these drugs
             may interfere with the activity of ipilimumab and nivolumab if administered at the
             time of the first ipilimumab dose; inhaled or topical steroids and adrenal replacement
             doses =< 10 mg daily prednisone equivalents are permitted in the absence of active
             autoimmune disease; participants are permitted to use topical, ocular,
             intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic
             absorption); physiologic replacement doses of systemic corticosteroids are permitted,
             even if >= 10 mg/day prednisone equivalents; 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; use of anabolic steroids is permitted

          -  Participants with clinical or radiographic evidence of pancreatitis are 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

          -  Participants should be excluded if they have had prior treatment with an anti-PD-1,
             anti-programmed cell death ligand 1 (PD-L1), anti-programmed cell death ligand 2
             (PD-L2), anti-CTLA-4 antibody, or any other antibody or drug specifically targeting
             T-cell co-stimulation or immune checkpoint pathways; prior immune modulating therapy
             including vaccines may be eligible; prior immune events must be evaluated and the risk
             for new events which may represent continued sub clinical disease or a new process at
             previously damaged site or immune potentiation (e.g. ipilimumab followed by IL2
             causing bowel perforation, ipilimumab followed by indoleam
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose of nivolumab
Time Frame:56 days
Safety Issue:
Description:Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least >= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized.

Secondary Outcome Measures

Measure:Objective response rate
Time Frame:Up to 3 years
Safety Issue:
Description:The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma [cHL]) and their corresponding 95% confidence intervals (calculated using exact binomial) will be reported separately for solid tumor and cHL according to treatment (combination therapy and single agent) using designated response criteria. Descriptive statistics will also be compiled for duration of response.
Measure:Immune function
Time Frame:Up to 3 years
Safety Issue:
Description:Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on immune function (human immunodeficiency virus [HIV] viral load, CD4 and CD8 cells).
Measure:Change in immune status
Time Frame:Baseline up to 3 years
Safety Issue:
Description:Change in immune status from pre-study to the end of study will be examined using a nonparametric Wilcoxon signed-rank test.
Measure:Change in HIV viral load
Time Frame:Baseline up to 3 years
Safety Issue:
Description:Change in HIV viral load from pre-study to the end of study will be examined using a nonparametric Wilcoxon signed-rank test.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Institute (NCI)

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