CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer

November 13, 2019 updated by: University of Wisconsin, Madison

Phase I Dose Escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer

The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of six patients will be treated in each dose level. The investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is an open label, single-center Phase I study. All subjects will receive bicalutamide 150mg orally days 1-28. Subjects will receive CP-675,206 IV over one hour on day 29. Doses will range from 6 mg/kg to 15 mg/kg. This cycle will be repeated once at month 3. Once the maximum tolerated dose has been determined, up to 6 additional subjects will be enrolled.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • At least 18 years of age & histologic diagnosis of adenocarcinoma of the prostate
  • Completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease
  • Clinical Stage D0 prostate cancer with rising PSA and PSA >2ng/ml.
  • ECOG performance of <2
  • Normal hematologic, renal and liver function

Exclusion Criteria:

  • Cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy.
  • No prior treatment with an LHRH agonist or nonsteroidal antiandrogen such as casodex or flutamide
  • No evidence for metastatic disease per bone scan or CT scan of the abdomen and pelvis
  • No prior treatment with anti-CTLA 4 monoclonal antibody
  • No history of known autoimmune disorder or HIV, hepatitis B or hepatitis C
  • No known brain metastases
  • No history of inflammatory bowel conditions including diverticulitis, ulcerative colitis, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
Drug: Bicalutamide and CP-675,206 (Tremelimumab)

Dose level -1 :

Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 3 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)

Other Names:
  • Casodex
  • Tremelimumab
Drug: Bicalutamide, CP-675,206 (tremelimumab)

Dose level 1:

Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 6 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)

Other Names:
  • Casodex
  • Tremelimumab
Drug: Bicalutamide, CP-675,206

Final Dose Level:

Bicalutamide 150 mg p.o. q.d. day 1-28, day 85-112

At month 9, if evidence of PSA progression:

Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 (MTD dose) I.V. over 1 hour, day 29

Other Names:
  • Casodex
  • Tremelimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
Time Frame: Up to 12 months after treatment with study agent
Up to 12 months after treatment with study agent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With an Increase in PSA Doubling Time
Time Frame: Up to 18 months after last dose of study agent
Up to 18 months after last dose of study agent
Number of Participants With PSA Recurrence.
Time Frame: one year
PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO07808
  • A534260 (Other Identifier: UW Madison)
  • SMPH/MEDICINE/MEDICINE*H (Other Identifier: UW Madison)
  • H-2008-0086 (Other Identifier: Institutional Review Board)
  • NCI-2011-00713 (Registry Identifier: NCI Trial ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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