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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT02408861
First received: April 3, 2015
Last updated: May 23, 2017
Last verified: May 2017
  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 solid tumors have spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may block tumor growth in different ways by targeting certain cells. 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 solid tumors.

Condition Intervention Phase
Advanced Malignant Solid Neoplasm Anal Carcinoma HIV Infection Kaposi Sarcoma Lung Carcinoma Metastatic Malignant Solid Neoplasm Unresectable Solid Neoplasm Biological: Ipilimumab Other: Laboratory Biomarker Analysis Biological: Nivolumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV Associated Solid Tumors With an Expansion Cohort in HIV Associated Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of nivolumab defined as the starting dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT [ Time Frame: 56 days ]
    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:
  • Change in HIV viral load [ Time Frame: Baseline to 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.

  • Change in immune status [ Time Frame: Baseline to 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.

  • 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 (HIV viral load, CD4 and CD8 cells).

  • 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) and their corresponding 95% confidence intervals (calculated using exact binomial) will be reported using designated response criteria. Descriptive statistics will be reported for response based on Immune-Related Response Criteria.


Other Outcome Measures:
  • Circulating cytokine markers by multiplex assay [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.

  • Herpesvirus loads (EBV, KSHV, CMV) in plasma [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.

  • Herpesvirus specific CD8 and CD4 T cells in PBMC [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.

  • HIV reactive T cells [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.

  • HPV types in anal swabs (anal cancer cases) [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.

  • Intratumor immune cells by IHC [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.

  • Latent herpesvirus (EBV, KSHV, CMV) in PBMC [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.

  • Latent HIV loads in PBMC using outgrowth assay [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.

  • Viral transcription in tumor biopsies (Kaposi sarcoma cases) [ Time Frame: Up to 3 years ]
    Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test.


Estimated Enrollment: 42
Actual Study Start Date: August 27, 2015
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (nivolumab, ipilimumab)
Patients receive nivolumab IV over 60 minutes on day 1. Patients in dose level 2 also receive ipilimumab IV over 90 minutes on day 1 of every third course of nivolumab, and patients in dose level -2 also receive ipilimumab IV over 90 minutes on day 1 of every sixth course of nivolumab. Courses repeat every 14 days for up to 46 courses of nivolumab (with ipilimumab if receiving dose level 2 or -2) in the absence of disease progression or unacceptable toxicity.
Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • 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%)
  • Leukocytes >= 2,000/mm^3
  • Absolute neutrophil count >= 1,000/mm^3
  • Platelets >= 75,000/mm^3
  • 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
  • Serum lipase and amylase < 1.5 x ULN
  • AST (serum glutamic oxaloacetic transaminase [SGOT])/ALT (serum glutamate pyruvate transaminase [SGPT]) =< 3 X ULN
  • Creatinine < 1.5 UNL or creatinine clearance (CrCl) > 50 ml/min
  • Hemoglobin >= 9 g/dL
  • Serum albumin >= 2.8 g/dL
  • HIV plasma HIV-1 ribonucleic acid (RNA) below detected limit obtained by Food and Drug Administration (FDA)-approved assays (limit of detection: 75) 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 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
  • Participants must be purified protein derivative (PPD) negative; PPD positive participants are permitted if prophylaxis has been completed prior to enrollment
  • 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 to 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 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 Cohort:

    • 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, only participants with CD4 count > 200/mm^3 will be enrolled in this cohort; the expansion is limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer

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 indoleamine 2,3-dioxygenase [IDO] inhibitor resulting in clinical hypophysitis); please keep in mind that inflammatory events may occur weeks to months following the last dose of ipilimumab and possibly nivolumab; assessment of potential effects of prior therapy should include:

    • Immune status
    • Organ damage
    • Risk of autoimmunity
    • Immunopotentiation
  • The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except =< grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs)
  • The subject has a primary brain tumor
  • Participant has >= grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative)
  • Opportunistic infection within the last 3 months
  • Participants 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-Barré 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 participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; participants with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and participants 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; participants 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)
  • Participants who have had evidence of Clostridium (C.) difficile infection, active or acute diverticulitis, intra-abdominal abscess, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02408861

Locations
United States, California
UCLA Center for Clinical AIDS Research and Education Recruiting
Los Angeles, California, United States, 90035
Contact: Ronald T. Mitsuyasu    888-798-0719    rmitsuya@mednet.ucla.edu   
Principal Investigator: Ronald T. Mitsuyasu         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Scott D. Christensen    916-734-5967    schristensen@ucdavis.edu   
Principal Investigator: Scott D. Christensen         
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Chia-Ching (Jackie) Wang    415-476-4082 ext 146    chia-ching.wang@ucsf.edu   
Principal Investigator: Chia-Ching (Jackie) Wang         
UCSF Medical Center-Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Chia-Ching (Jackie) Wang    415-476-4082 ext 146    chia-ching.wang@ucsf.edu   
Principal Investigator: Chia-Ching (Jackie) Wang         
United States, Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Juan C. Ramos    305-243-1326    jramos2@med.miami.edu   
Principal Investigator: Juan C. Ramos         
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Paul G. Rubinstein    312-864-6000    prubinstein@cookcountyhhs.org   
Principal Investigator: Paul G. Rubinstein         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Nina D. Wagner-Johnston    410-955-8839    nwagner7@jhmi.edu   
Principal Investigator: Nina D. Wagner-Johnston         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lee Ratner    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Lee Ratner         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mark A. Dickson    646-888-4164    dicksonm@mskcc.org   
Principal Investigator: Mark A. Dickson         
Montefiore Medical Center-Einstein Campus Recruiting
The Bronx, New York, United States, 10461
Contact: Lakshmi Rajdev    718-405-8404    lrajdev@montefiore.org   
Principal Investigator: Lakshmi Rajdev         
Montefiore Medical Center-Weiler Hospital Recruiting
The Bronx, New York, United States, 10461
Contact: Lakshmi Rajdev    718-405-8404    lrajdev@montefiore.org   
Principal Investigator: Lakshmi Rajdev         
Montefiore Medical Center - Moses Campus Recruiting
The Bronx, New York, United States, 10467-2490
Contact: Lakshmi Rajdev    718-405-8404    lrajdev@montefiore.org   
Principal Investigator: Lakshmi Rajdev         
United States, North Carolina
Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Dirk P. Dittmer    919-966-7960    ddittmer@med.unc.edu   
Principal Investigator: Dirk P. Dittmer         
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Michael S. Lee    919-843-7180    michael_s_lee@med.unc.edu   
Principal Investigator: Michael S. Lee         
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Robert A. Baiocchi    614-293-3196    robert.baiocchi@osumc.edu   
Principal Investigator: Robert A. Baiocchi         
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Douglas F. Beach    215-829-6088    douglas.beach@uphs.penn.edu   
Principal Investigator: Douglas F. Beach         
United States, Washington
Benaroya Research Institute at Virginia Mason Recruiting
Seattle, Washington, United States, 98101-2795
Contact: David M. Aboulafia    206-223-6193    hemdma@vmmc.org   
Principal Investigator: David M. Aboulafia         
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Manoj P. Menon    800-422-6237    mmenon@fhcrc.org   
Principal Investigator: Manoj P. Menon         
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Manoj P. Menon    800-422-6237    mmenon@fhcrc.org   
Principal Investigator: Manoj P. Menon         
Australia, New South Wales
Saint Vincent's Hospital Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Mark N. Polizzotto    61-2-9385-0900      
Principal Investigator: Mark N. Polizzotto         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lakshmi Rajdev AIDS Malignancy Consortium
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02408861     History of Changes
Other Study ID Numbers: NCI-2015-00461
NCI-2015-00461 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AMC-095
PAMC-095_R03PAPP01
AMC-095 ( Other Identifier: AIDS Malignancy Consortium )
AMC-095 ( Other Identifier: CTEP )
U01CA121947 ( US NIH Grant/Contract Award Number )
UM1CA121947 ( US NIH Grant/Contract Award Number )
Study First Received: April 3, 2015
Last Updated: May 23, 2017

Additional relevant MeSH terms:
Carcinoma
Neoplasms
HIV Infections
Lung Neoplasms
Sarcoma, Kaposi
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Herpesviridae Infections
DNA Virus Infections
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on June 23, 2017