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A Rollover Phase II Study Testing the Biologic Activity and Safety of AGS-003 in Renal Cell Carcinoma Subjects With Prolonged Response or Stable Disease and Ongoing AGS-003 Treatment in Protocol AGS-003-004 or AGS-003-006


Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Renal Cell Carcinoma

Thank you

Trial Information

A Rollover Phase II Study Testing the Biologic Activity and Safety of AGS-003 in Renal Cell Carcinoma Subjects With Prolonged Response or Stable Disease and Ongoing AGS-003 Treatment in Protocol AGS-003-004 or AGS-003-006


AGS-003-005 is a rollover, open label, Phase II clinical study testing the biologic activity
and safety of AGS-003 in subjects who have experienced either partial responses or prolonged
stable disease and continue to benefit from ongoing treatment with AGS-003 in protocols
AGS-003-004 or AGS-003-006.

Rollover subjects from AGS-003-004 will continue with AGS-003 monotherapy booster dosing
until disease progression or until a discontinuation criterion is reached.

Subjects that progress on AGS-003 monotherapy (from the AGS-003-004 protocol) may start
sunitinib treatment and re-initiate AGS-003 therapy beginning with the induction phase
dosing schedule.

Rollover subjects from AGS-003-006 will continue sunitinib dosing in combination with
booster dosing of AGS-003 until disease progression or until a discontinuation criterion is
reached.

If a subject has disease progression due to a new tumor lesion, upon consultation between
the investigator, Argos representatives and the Argos medical monitor, the subject may be
considered for re-manufacture of study product (from the new metastatic lesion) and dosing
with this new product in combination with sunitinib beginning with the induction phase
dosing schedule.

For those subjects initiating treatment with the induction phase as described above,
restaging imaging occurs at screening (baseline), prior to the fifth dose in the induction
phase (as applicable) and every 12 weeks during the booster phase (at the start of the
sunitinib holiday, 2 weeks prior to the next AGS-003 dose).

For subjects on combination therapy, if dosing with sunitinib is stopped due to
sunitinib-related issues, treatment with AGS-003 may continue.

Close-out visits will occur upon disease progression (other than circumstances discussed
above which are eligible for re-induction) or upon decision to terminate the study by the
sponsor.

Quarterly follow-up for survival for each subject will occur by telephone interview for 1
year following the last AGS-003 administration or study termination.


Inclusion Criteria:



- 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:

1. White blood cell (WBC) ≥ 4000/µL (≥ 4.0 x 103/µL)

2. Absolute neutrophil count (ANC) ≥ 1500/µL (≥ 1.5 x 103/µL)

3. Platelets ≥ 100,000/µL (≥ 100 x 103/µL)

4. Hemoglobin (Hgb) ≥ 9.0 g/dL

- Adequate renal and hepatic function, as defined by the following criteria:

1. 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

2. Total serum bilirubin ≤ 1.5 x ULN

3. 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:

1. Prothrombin time (PT) ≤ 1.5 x ULN

2. Activated partial thromboplastin time (PTT) < 1.5 x ULN

3. Corrected calcium ≤ 11.5 mg/dL

- 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

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

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

- Signed and dated informed consent document indicating that the subject (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment

- No brain metastases detected by magnetic resonance imaging (MRI).

Exclusion Criteria:

- 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

NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other
signs/symptoms of autoimmune disease are not exclusionary.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor response

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

AGS-003-005

NCT ID:

NCT01482949

Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Renal Cell Carcinoma
  • RCC
  • Kidney Cancer
  • Renal Cancer
  • Arcelis
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Emory UniversityAtlanta, Georgia  30322
Blumenthal Cancer Center/Carolinas Medical CenterCharlotte, North Carolina  28203
The Indiana University Cancer CenterIndianapolis, Indiana  46202
Urology of Virginia - Sentara Medical GroupNorfolk, Virginia  23502