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

Study Details

Primary objective:

Maximum tolerated dose of nivolumab [Time Frame: 56 days]

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 objectives:

  1. Objective response rate [Time Frame: Up to 3 years]

    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.

  2. Immune function [Time Frame: Up to 3 years]

    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).

  3. Change in immune status [Time Frame: Baseline up to 3 years]

    Change in immune status from pre-study to the end of study will be examined using a nonparametric Wilcoxon signed-rank test.

  4. Change in HIV viral load [Time Frame: Baseline up to 3 years]

    Change in HIV viral load from pre-study to the end of study will be examined using a nonparametric Wilcoxon signed-rank test.

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 
  • HIV-1 infection
  • Participants must have measurable disease
  • Prior therapy for metastatic disease permitted
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
  • HIV viral load should be well suppressed, defined as below the limit of detection of the local assay or below 75 copies/mLCD4 count requirements differ depending on progression of the study. (Please contact study team for details.)
  • Participants must be purified protein derivative (PPD) negative
  • Women of childbearing 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
  • Participants MUST receive appropriate care and treatment for HIV infection and should be under the care of a physician experienced in HIV management
  • Participants who have hepatitis C and hepatitis B 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

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 active brain metastases or leptomeningeal metastases must be excluded
  • Participants with clinical or radiographic evidence of pancreatitis are excluded
  • Uncontrolled intercurrent illness 
  • 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
  • Other inclusion/exclusion criteria are present. Please contact the study team for a complete list.
Aids Malignancy Consortium
Principal Investigator(s)
Dr. Faysal Haroun
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