Durvalumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

NCT02966587 | Withdrawn Phase 2 DMC FDA Drug

• 3 other identifiers: 9768NCI-2016-01618P30CA015704
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well durvalumab works in treating patients with prostate cancer that is resistant to hormones and has spread to other places in the body. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.

Conditions

Castration Levels of Testosterone; Hormone-Resistant Prostate Cancer; Microsatellite Instability

Outcome Measures

Primary Outcomes (1)

• Response rate to durvalumab defined according to modified RECIST 1.1 criteria or a reduction in PSA level >= 50%

  Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a response.

  Up to 3 years

Secondary Outcomes (6)

• Incidence of adverse events according to NCI-CTCAE version 4.0

  Up to 3 years

• Overall survival

  From the start of treatment until death from any cause, assessed up to 3 years

• PSA PFS

  From the start of treatment until PSA progression, assessed up to 3 years

• PSA response rate as defined per the PCWG3 criteria

  Up to 3 years

• Radiographic PFS

  From the start of treatment until disease progression, clinical progression, or death, whichever occurs first, assessed up to 3 years

Other Outcomes (4)

• Mismatch repair gene mutational status and mutational load determined by UW-OncoPlex

  Up to 3 years

• PD-L1 expression assessed by IHC and transcript profiling (e.g. qRT-PCR)

  Up to 3 years

• Relative location of T-cells using CD3/CD8 IHC

  Up to 3 years

Study Arms (1)

Treatment (durvalumab)

EXPERIMENTAL

Patients receive durvalumab IV over 60 minutes on day 1. Courses repeat every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Biological: Durvalumab; Other: Laboratory Biomarker Analysis

Interventions

Durvalumab BIOLOGICAL

Given IV

Also known as: Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

Treatment (durvalumab)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (durvalumab)

Eligibility Criteria

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

You may qualify if:

• Patient must have evidence of castration resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 3 \[PCWG3\] criteria) and a castrate serum testosterone level (i.e. =\< 50 mg/dL); if a subject also received an anti-androgen, he must first progress through antiandrogen withdrawal prior to being eligible; the minimum timeframe to document failure of anti-androgen withdrawal will be four weeks
• Patients must have received at least one of the approved products known to improve the overall survival of patients with metastatic castration resistant prostate cancer (i.e. abiraterone, enzalutamide, sipuleucel-t, radium-223, docetaxel or cabazitaxel)
• Microsatellite instability as determined by MSI-plus assay
• Ability to understand and the willingness to sign a written informed consent
• Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\] authorization) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Life expectancy of \>= 4 months
• Hemoglobin \>= 9.0 g/dL Note: patient may receive blood transfusion to achieve a hemoglobin \>= 9.1 g/dL; however, hemoglobin must be stable at or above 9 g/dL two weeks prior to dosing
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9 /L (\>= 1500 per mm\^3)
• Platelet count \>= 100 x 10\^9/L (\>= 100,000 per mm\^3)
• Serum bilirubin =\< 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician and the study principal investigator (PI)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =\< 5 x ULN
• Serum creatinine clearance (CL) \> 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
• Body weight \> 30 kg

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Previous enrollment in the present study
• Participation in another clinical study with an investigational product during the last 14 days
• Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
• History of another primary malignancy except for:
• Malignancy treated with curative intent and with no known active disease \>= 5 years before the first dose of study drug and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ)
• Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =\< 28 days prior to the first dose of study drug (if sufficient wash-out time has not occurred due to the schedule or pharmacokinetics \[PK\] properties of an agent, a longer wash-out period may be required)
• Major surgical procedure (as defined by the local/lead site PI) within 28 days prior to the first dose of investigational product (IP); Note: local surgery of isolated lesions for palliative intent is acceptable
• Ongoing systemic therapy (other than a luteinizing hormone-releasing hormone agonists \[LHRH\] agonist/antagonist) for prostate cancer including, but not limited to:
• CYP-17 inhibitors (e.g. ketoconazole, abiraterone)
• Antiandrogens (e.g. bicalutamide, nilutamide)
• Second generation antiandrogens (e.g. ARN-509)
• Immunotherapy (e.g. sipuleucel-T)

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Microsatellite Instability

Interventions

durvalumab; Immunoglobulin G; Disulfides

Condition Hierarchy (Ancestors)

Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Study Officials

• Michael Schweizer

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: May 15, 2018
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

US (1)