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A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors (IVY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02009449
Recruitment Status : Active, not recruiting
First Posted : December 12, 2013
Last Update Posted : January 24, 2024
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

Condition or disease Intervention/treatment Phase
Melanoma Prostate Cancer Ovarian Cancer Renal Cell Carcinoma Colorectal Carcinoma Pancreatic Carcinoma Non-small Cell Lung Carcinoma Solid Tumors Breast Cancer Drug: Pegilodecakin Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) Drug: gemcitabine/nab-paclitaxel Drug: Capecitabine Drug: Pazopanib Drug: Pembrolizumab Drug: Paclitaxel Drug: nivolumab Drug: Gemcitabine/carboplatin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors
Actual Study Start Date : November 15, 2013
Actual Primary Completion Date : February 19, 2019
Estimated Study Completion Date : August 25, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: Dose Escalation Cohort 1
Pegilodecakin (1 ug/kg) - Daily subcutaneous (SC) injections of pegilodecakin for up to 22 months
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 2
Pegilodecakin (2.5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 3
Pegilodecakin (5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 4
Pegilodecakin (10 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 5
Pegilodecakin (20 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Escalation Cohort 6
Pegilodecakin (40 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Dose Expansion Cohort 1
at least 15 RCC participants will be dosed with pegilodecakin for up to 22 months
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part B: Dose Escalation Cohort 1

Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Other Name: Taxol or taxotere and paraplatin or platinol
Experimental: Part B: Dose Escalation Cohort 2

Pegilodecakin (5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Other Name: Taxol or taxotere and paraplatin or platinol
Experimental: Part B: Dose Escalation Cohort 3

Pegilodecakin (10 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Other Name: Taxol or taxotere and paraplatin or platinol
Experimental: Part B: Dose Expansion Cohort

Daily SC injection with pegilodecakin with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles.

Day 1

  • Paclitaxel 200/175 mg/m2 IV, or
  • Docetaxel 75/65 mg/m2 IV And
  • Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or
  • Cisplatin 75mg/m2 IV
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Day 1 of every 21 day cycle
Other Name: Taxol or taxotere and paraplatin or platinol
Experimental: Part C: Dose Escalation Cohort 1

Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
Experimental: Part C: Dose Escalation Cohort 2

Pegilodecakin (5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
Experimental: Part C: Dose Escalation Cohort 3

Pegilodecakin (10 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
Experimental: Part C: Dose Expansion Cohort 1

Daily SC injection with pegilodecakin with FOLFOX4 Every 14 days FOLFOX4; (14 days = 1 cycle) ;

Day 1

  • Oxaliplatin 85 mg/m2 IV over 2 hours
  • Leucovorin 200 mg/m2 IV over 2 hours followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
  • Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by
  • 5-FU 400 mg/m2 IV bolus and
  • 5-FU 600 mg/m2/day IV over 22 hours
 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Intravenous administration on Day 1 and 2 of every 14 day cycle
Other Name: Eloxatin®/Leucovorin/5-FU
Experimental: Part D: Dose Escalation Cohort 1

Pegilodecakin (5 ug/kg) daily subcutaneous injections with Gemcitabine and nab-paclitaxel on Days 1, 8, 15 of each cycle (28 days = 1 cycle).

Nab-paclitaxel 125 mg/m2 IV over 30 minutes followed by

• Gemcitabine 1000 mg/m2 IV.

 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: gemcitabine/nab-paclitaxel
Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
Other Name: Gemzar/Abraxane ABI-007
Experimental: Part E: Dose Escalation Cohort 1

Pegilodecakin (10 ug/kg) daily subcutaneous injections with capecitabine BID daily for 14 days of each cycle (21 days= 1 cycle).

• Capecitabine 1000 mg/m2 po BID

 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: Capecitabine
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Other Name: Xeloda
Experimental: Part F: Dose Escalation Cohort 1

Pegilodecakin (10 ug/kg) daily subcutaneous injections with paclitaxel on Days 1, 8, 15 of each cycle (28 days= 1 cycle)

• Paclitaxel 80 mg/ m2 IV

 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: Paclitaxel

Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle)

• Paclitaxel 80 mg/ m2 IV
Experimental: Part G: Dose Escalation Cohort 1

Pegilodecakin (10 ug/kg) daily subcutaneous injections with pazopanib orally given daily for 14 days of each cycle (21 days= 1 cycle)

• Pazopanib 800 mg po QD

 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: Pazopanib
Pazopanib will be administered orally daily continuously
Other Name: GW786034
Experimental: Part H: Dose Escalation Cohort 1

Pegilodecakin (10 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle).

• Pembrolizumab 2 mg/kg IV over 30 min

 Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10

Drug: Pembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Other Name: Keytruda, MK-3475
Experimental: Part I: Dose Escalation Cohort 1

Pegilodecakin (20 ug/kg) daily subcutaneous injections with nivolumab on Day 1 of each cycle (14 days= 1 cycle).

• Nivolumab 3 mg/kg IV over 60 min

 Drug: nivolumab
Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
Other Name: Keytruda
Experimental: Part H: Dose Escalation Cohort 2

Pegilodecakin (20 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle).

• Pembrolizumab 2 mg/kg IV over 30 min

 Drug: Pembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Other Name: Keytruda, MK-3475
Experimental: Part H: Dose Escalation Cohort 3

Pegilodecakin (40 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle).

• Pembrolizumab 2 mg/kg IV over 30 min

 Drug: Pembrolizumab
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Other Name: Keytruda, MK-3475
Experimental: Part J: Dose Escalation Cohort 1
Pegilodecakin (10 ug/kg) daily subcutaneous injections with gemcitabine and carbolplatin on Days 1,8 of each cycle (21 days=1 cycle) until disease progression gemcitabine 1000mg/m2 IV over 30 minutes followed by carboplatin AUC2 over 60 minutes
 Drug: Gemcitabine/carboplatin
gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)
Other Name: gemzar/paraplatin


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability as measured by incidence of adverse events [ Time Frame: up to 12 months ]
  2. Pharmacokinetic (PK) parameters [ Time Frame: up to 12 months ]
    PK parameters including the serum trough concentration (Minimal Drug Concentration (Cmin)), the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½).


Secondary Outcome Measures :
  1. Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC) [ Time Frame: up to 12 months ]
  2. Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC) [ Time Frame: approximatley 4 months ]
  3. Anti-Pegilodecakin antibody formation [ Time Frame: up to 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Part A Escalation Cohorts:

o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies

Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:

  • Tumors with all histological diagnosis or tissue origin may be enrolled

  • Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.

    • Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC)
    • At least 18 years of age
    • Performance Status of 0 or 1
    • Adequate organ function

Exclusion Criteria:

  • Hematologic malignancies
  • Pregnant or lactating
  • Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders
  • Myocardial infarction within the last 6 months
  • Unstable angina, or unstable cardiac arrhythmia requiring medication
  • Surgery within the last 28 days
  • Systemic fungal, bacterial, viral, or other infection
  • History of bleeding diathesis within the last 6 months
  • Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009449


Locations
Layout table for location information
United States, California
UCLA Medical Hematology & Oncology
Los Angeles, California, United States, 90024
UCSF
San Francisco, California, United States
United States, Colorado
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States, 34232
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Oklahoma
Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Eli Lilly and Company
ARMO BioSciences
Investigators
Layout table for investigator information
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02009449    
Other Study ID Numbers: 17159
J1L-AM-JZGA ( Other Identifier: Eli Lilly and Company )
AM0010-001 ( Other Identifier: ARMO BioSciences )
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Phase 1/Phase 1b
Oncology
Cancer
Solid Tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urogenital Diseases
Male Urogenital Diseases
Endocrine Gland Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Endocrine System Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases