Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer

NCT03024216 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Rosser-2015-4
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to compare the safety and tolerability of sequential atezolizumab followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously treated with docetaxel or cabazitaxel.

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• Assessment of AE by CTCAE v4.0

  12 months

• Clinically significant changes in vital signs and clinical laboratory results

  12 months

Secondary Outcomes (7)

• Radiographic progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using PCWG2 criteria, or death from any cause on study

  12 months

• Radiographic progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using modified RECISTv1.1, or death from any cause on study

  12 months

• Confirmed objective tumor response in patients with measurable soft tissue disease at baseline, as assessed by the investigator per PCWG2 criteria

  12 months

• Confirmed objective tumor response in patients with measurable soft tissue disease at baseline, as assessed by the investigator per modified RECISTv1.1 criteria

  12 months

• Duration of confirmed objective response in patients with measurable soft tissue disease at baseline

  12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Atezolizumab1200 mg IV week 1 and week 4 followed by Sipuleucel-T administered weeks 6, 8, and 10

Drug: Atezolizumab1200 mg IV; Drug: Sipuleucel-T

Arm 2

EXPERIMENTAL

Sipuleucel-T administered week 1, 3, and 5 followed by Atezolizumab1200 mg IV weeks 7 and 10

Drug: Atezolizumab1200 mg IV; Drug: Sipuleucel-T

Interventions

Atezolizumab1200 mg IV DRUG

Subjects in ARM 1 will receive 2 doses of atezolizumab 1200 mg intravenously (week 1 and week 4). If no dose limiting toxicity continue onto maintenance, week 13 and receive atezolizumab 1200 mg intravenously every 3 weeks until toxicities or lack of clinical benefit. Subjects in ARM 2 will receive 2 doses at approximately 3 weeks each of atezolizumab 1200 mg intravenously (weeks 7 and 10). If no dose limiting toxicity, continue to receive atezolizumab 1200 mg intravenously every 3 weeks, starting week 13, until toxicities or lack of clinical benefit.

Arm 1; Arm 2

Sipuleucel-T DRUG

Subjects in ARM 1 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 6, 8, 10). Subjects in ARM 2 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 1, 3 and 5)

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• Patients must meet the following criteria for study entry:
• Documentation of Disease:
• \- Progressive castration-resistant metastatic prostate cancer with pathologically confirmed adenocarcinoma of the prostate without small cell features.
• Patients must have Measurable or Non-measurable disease per Prostate Cancer Working Group 2 (PCWG2) response criteria (RECIST criteria will only apply to soft tissue lesions
• Measurable Disease
• For extra-nodal lesions to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT.
• For lymph nodes to be considered measureable (i.e., target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT.
• Non-measurable Disease
• All other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions.
• Lesions that are considered non-measurable include bone lesions (only).
• Asymptomatic or mildly symptomatic metastatic CRPC defined as pain that is relieved by acetaminophen or a non-steroidal anti-inflammatory
• Asymptomatic: Score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours)
• Mildly symptomatic: Score of 2-3 on BPI-SF Question #3
• Progressive disease:
• Patients must have progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy. For patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry.
• Any approved or investigational anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 4 weeks prior to initiation of study treatment.
• Palliative radiotherapy for bone metastases ≥ 4 weeks prior to Cycle 1, Day 1 is allowed
• Treatment for prostate cancer with any of the following:
• Herbal products that may decrease PSA levels within 4 weeks prior to enrollment
• Use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to administration of first dose.
• Prior use of ketoconazole for within 7 days of administration of first dose.
• AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia
• Bisphosphonate therapy for symptomatic hypercalcemia
• Use of bisphosphonate therapy for bone metastasis is allowed.
• The prior or concurrent use of a RANKL inhibitor denosumab
• Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
• Structurally unstable bone lesions suggesting impending fracture
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease;
• Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible.

Sponsors & Collaborators

• University of Hawaii: lead
• Genentech, Inc.: collaborator
• Dendreon: collaborator

Study Sites (3)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Prostate Oncology Specialists, Inc.

Marina del Rey, California, 90292, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Related Publications (1)

• Dorff T, Hirasawa Y, Acoba J, Pagano I, Tamura D, Pal S, Zhang M, Waitz R, Dhal A, Haynes W, Shon J, Scholz M, Furuya H, Chan OTM, Huang J, Rosser C. Phase Ib study of patients with metastatic castrate-resistant prostate cancer treated with different sequencing regimens of atezolizumab and sipuleucel-T. J Immunother Cancer. 2021 Aug;9(8):e002931. doi: 10.1136/jitc-2021-002931.

  PMID: 34376554 DERIVED

MeSH Terms

Interventions

sipuleucel-T

Study Officials

• Jared Acoba, MD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 18, 2017
• Study Start: February 6, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

US (3)