A Rollover Protocol for Subjects Previously Treated With AGS-003

NCT01482949 | Terminated Phase 2

• 1 other identifier: AGS-003-005
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.

Conditions

Renal Cell Carcinoma

Keywords

RCC; Kidney Cancer; Renal Cancer; Arcelis

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).

  From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.

Secondary Outcomes (11)

• Clinical benefit (stable disease or response)

  From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.

• Immune function

  From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.

• Progression Free Survival (PFS)

  From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.

• Overall Survival (OS)

  From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.

• Treatment-emergent Adverse Events

  From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.

Study Arms (1)

AGS-003 in combination with sunitinib

EXPERIMENTAL

Subjects will undergo Induction (AGS-003 every 3 weeks until 5 doses are administered) followed by Booster (AGS-003 at 3 month intervals). Subjects that will begin sunitinib therapy will be on this arm.

Drug: AGS-003

Interventions

AGS-003 DRUG

Autologous Dendritic Cell Immunotherapy

Also known as: Arcelis

AGS-003 in combination with sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-006.
• Measurable disease that can be monitored per RECIST throughout the course of study participation.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematologic function, as defined by the following criteria:
• White blood cell (WBC) ≥ 4000/µL (≥ 4.0 x 103/µL)
• Absolute neutrophil count (ANC) ≥ 1500/µL (≥ 1.5 x 103/µL)
• Platelets ≥ 100,000/µL (≥ 100 x 103/µL)
• Hemoglobin (Hgb) ≥ 9.0 g/dL
• Adequate renal and hepatic function, as defined by the following criteria:
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or, if serum creatinine \> 1.5 x ULN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
• Total serum bilirubin ≤ 1.5 x ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
• Adequate coagulation function as defined by the following criteria:
• Prothrombin time (PT) ≤ 1.5 x ULN

You may not qualify if:

• Any serious medical condition considered by the investigator to constitute an unwarranted high risk for investigational treatment
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening computed tomography (CT) scan or MRI
• Pregnancy or breastfeeding
• Active autoimmune disease or condition requiring chronic immunosuppressive therapy

Sponsors & Collaborators

• Argos Therapeutics: lead

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Lee F Allen, M.D., Ph.D.

  Argos Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 1, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)