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An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced Renal Cell Carcinoma, Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

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Trial Information

An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

Inclusion Criteria


Key Inclusion Criteria for Tumor Collection:

1. Diagnosis or clinical signs of advanced RCC as defined by TNM classification of [any
T, any N, M1].

2. Scheduled for unilateral or partial nephrectomy

Key Exclusion Criteria for Tumor Collection:

1. RCC that does not meet TNM classification of [any T, any N, M1].

2. Known inability to undergo sunitinib treatment as currently labeled, due to
pre-existing medical conditions

3. Requirement for systemic chronic immunosuppressive drugs or corticosteroids

4. Brain metastases detected by MRI or computerized cranial tomography, if central
nervous system scans are available

5. Four or more of the following preoperative risk factors:

1. Albumin < LLN

2. LDH > ULN

3. Symptoms at presentation due to metastases (i.e., bone pain, neurologic
symptoms)

4. Retroperitoneal adenopathy

5. Supradiaphragmatic adenopathy

6. Clinical stage T3 or T4

7. Liver metastases

Key Inclusion Criteria for Treatment Study:

1. Advanced disease, histologically assessed as RCC, with a component of clear cell
histology

2. Measurable metastatic disease that can be monitored throughout the course of the
study participation per RECIST 1.1 (refer to Appendix C)

3. Subjects who are candidates for a first-line therapy initiating with sunitinib

4. Time from diagnosis to treatment < 1 year

5. Karnofsky performance status (KPS) ≥ 80%

6. Life expectancy of 6 months or greater

7. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to
Grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for
Adverse Events Version 4.0

8. Adequate hematologic, renal, hepatic, and coagulation function

9. Negative serum pregnancy test for female subjects with reproductive potential, and
agreement of all male and female subjects of reproductive potential to use a reliable
form of contraception during the study and for 12 weeks after the last dose of study
drug

10. Normal ECG or clinically non-significant finding(s) at Screening

11. Able to abstain from taking prohibited drugs, either prescription or
non-prescription, during the treatment phase of the study

12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures

Key Exclusion Criteria for Treatment Study:

1. Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC,
including immunotherapy, chemotherapy, hormonal, or investigational therapy

2. Prior history of malignancy other than RCC within the preceding 3 years, except for
adequately treated in situ carcinomas or non-melanoma skin cancer

3. History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or evidence of brain or leptomeningeal disease

4. Patients with 5 or more of the following risk factors:

1. Time from diagnosis to treatment <1 year

2. Hgb < LLN

3. Corrected calcium > 10.0 mg/dL

4. KPS < 80%

5. Neutrophils > ULN

6. Platelets > ULN

5. Planned or elective surgical treatment or radiation therapy post-nephrectomy within
28 days before Visit 1 (Day 0)

6. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)

7. Clinically significant cardiovascular conditions within 3 months prior to
Randomization

8. Significant gastrointestinal abnormalities

9. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication

10. Active autoimmune disease or condition requiring chronic immunosuppressive therapy

11. Clinically significant infections, including human immunodeficiency virus, syphilis,
and active hepatitis B or C

12. Current treatment with an investigational therapy on another clinical trial

13. Pregnancy or breastfeeding

14. Any serious medical condition or illness considered by the investigator to constitute
an unwarranted high risk for investigational treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Duration from randomization to death

Outcome Time Frame:

From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study

Safety Issue:

No

Principal Investigator

Robert Figlin, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

AGS-003-007

NCT ID:

NCT01582672

Start Date:

November 2012

Completion Date:

December 2015

Related Keywords:

  • Advanced Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • RCC
  • Kidney Cancer
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Loyola University Medical CenterMaywood, Illinois  60153
East Jefferson General HospitalMetairie, Louisiana  70011
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Virginia Mason Medical CenterSeattle, Washington  98111
Rush University Medical CenterChicago, Illinois  60612-3824
Madigan Army Medical CenterTacoma, Washington  98431-5048
Hartford HospitalHartford, Connecticut  06102-5037
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
University of MinnesotaMinneapolis, Minnesota  55455
Tulane University Medical CenterNew Orleans, Louisiana  70112
University of UtahSalt Lake City, Utah  
Duke University Medical CenterDurham, North Carolina  27710
SUNY Upstate Medical UniversitySyracuse, New York  13210
Oregon Health Sciences UniversityPortland, Oregon  
Nebraska Methodist HospitalOmaha, Nebraska  68114
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
California Pacific Medical Center Research InstituteSan Francisco, California  94115
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of Colorado HospitalDenver, Colorado  80262
Providence Portland Medical CenterPortland, Oregon  97213-3635
M.D. Anderson Cancer CenterHouston, Texas  77030
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
Albany Medical CenterAlbany, New York  12208
University of Maryland, Greenebaum Cancer CenterBaltimore, Maryland  21201
Vanderbilt University School of MedicineNashville, Tennessee  37232-6307
David Geffen School of Medicine at UCLALos Angeles, California  90095
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
University of Kansas Cancer CenterKansas City, Kansas  66160
University of Iowa Hospital and ClinicsIowa City, Iowa  52242
University of Virginia Health SystemCharlottesville, Virginia  22903
Urology of IndianaIndianapolis, Indiana  46254
Mayo Clinic - RochesterRochester, Minnesota  55905
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
MD Anderson - OrlandoOrlando, Florida  32806
Aurora Health CareElkhorn, Wisconsin  53121
Medical University of South Carolina (MUSC)Charleston, South Carolina  29425
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
The Urology Center of ColoradoDenver, Colorado  80211
Urology of VirginiaNewport News, Virginia  23606
Levine Cancer InstituteCharlotte, North Carolina  28211
John Theurer Cancer Center at Hackensack UMCHackensack, New Jersey  07601
Mercy Cancer CenterToledo, Ohio  43623
Jewish Hospital & St. Mary's HealthcareLouisville, Kentucky  40245
Associated Medical Professionals of New YorkSyracuse, New York  13210
Edward Hines Jr VA HospitalHines, Illinois  60141
Idaho Urologic InstituteMeridian, Idaho  83642
Samuel Oschin Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  
Vanguard Health ChicagoChicago, Illinois  60640
Associated Urologists of North CarolinaRaleigh, North Carolina  27607
University of Texas Medical Branch - GalvestonGalveston, Texas  77555
Advanced Urology, P.C.Parker, Colorado  80134
Emory Univeristy HospitalAtlanta, Georgia  30322
University of Illinois HospitalChicago, Illinois  60612
Edward H. Kaplan and AssociatesSkokie, Illinois  60076
Southern Illinois University - Simmons Cancer InstituteSpringfield, Illinois  62702
Franciscan St. Francis Health - Franciscan Physician Network Oncology and Hematology SpecialistsIndianapolis, Indiana  46237
Greater Baltimore Medical Center (GBMC)Baltimore, Maryland  21204
Karmanos Cancer Institute - Wayne State University School of MedicineDetroit, Michigan  48201
Cancer and Hematology Clinics of Western Michigan - Spectrum HealthGrand Rapids, Michigan  49503
Hematology Oncology Associates of CNYEast Syracuse, New York  13057
New York Medical College - Urology Center of WestchesterHawthorne, New York  10532
North Shore Long Island Jewish Hospital System - Monter Cancer CenterNew Hyde Park, New York  11040
Mount Sinai School of Medicine - Medical CenterNew York, New York  10029
Strong Memorial Hospital - University of Rochester Medical CenterRochester, New York  14642
Wake Forest Baptist Health - Wake Forest University School of MedicineWinston-Salem, North Carolina  27157
TriState Urologic Services PSC Inc. The Urology GroupCincinnati, Ohio  45212
St. Luke's Hospital - Bethlehem CampusBethlehem, Pennsylvania  18015
The Pennsylvania State University - Penn StateHershey, Pennsylvania  17033
Hershey Cancer Institute - Hershey Medical CenterHershey, Pennsylvania  17033
Greenville Hospital System - Cancer Centers of the CarolinasGreenville, South Carolina  29605
Seattle Cancer CenterSeattle, Washington  98109