Overview

T-Cell Responses to Neoantigens Post Treatment With Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer

Status:
Completed
Trial end date:
2019-11-04
Target enrollment:
0
Participant gender:
Male
Summary
The goal of this clinical research study is to study the impact of ipilimumab on the immune system of patients currently receiving hormone therapy. The safety of these drug combinations will also be studied. This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of melanoma. Its use to treat prostate cancer is investigational. Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Bristol-Myers Squibb
High Impact Clinical Research Support Program
Stand Up To Cancer
Treatments:
Antibodies, Monoclonal
Ipilimumab
Criteria
Inclusion Criteria:

1. Signed written Informed Consent for this protocol.

2. Agreed to participate in laboratory protocol PA13-0291 for the testing of biomarkers
as described in this clinical protocol.

3. Patients included in the study must be >/= 18 years old.

4. Histologically or cytologically confirmed carcinoma of the prostate.

5. Subjects must have metastatic prostate cancer mass tissue collection within 3 months
of study entry.

6. Evidence of metastatic disease on previous bone scan, CT scan and/or MRI.

7. Asymptomatic or minimally symptomatic.

8. Tumor progression while on hormone therapy with castrate levels serum testosterone
( criteria according to the Prostate Cancer Working Group 2 (PCWG2).Castrate levels of
testosterone must be maintained by surgical or medical means throughout the conduct of
the study.

9. ECOG performance status
10. Patients must have normal organ and marrow function as defined below: a) WBC >/=
2500/uL.; b) ANC >/= 1000/uL.; c) Platelets >/= 75 x 10^3/uL.; d) Hemoglobin >/= 9
g/dL.; e) Creatinine metastases. For patients with liver metastasis ALT Bilirubin total bilirubin
11. Patient agrees to use adequate contraception (barrier method of birth control) prior
to study entry, during therapy and up to 3 months after last dose of ipilimumab.

Exclusion Criteria:

1. Treatment with any of the following medications or interventions concomitantly or
within 28 days of starting ipilimumab: a.) Systemic corticosteroids. Use of inhaled,
intranasal, intra-articular and topical steroids is acceptable, as is a short course
(i.e. CT scans.; b.) External beam radiation therapy or major surgery requiring general
anesthetic.; c.) Any systemic therapy for prostate cancer (with the exception of
bisphosphonates and RANK-ligand inhibitors for bone metastases which are allowed)
including chemotherapy, secondary hormonal therapies (such as megestrol acetate,
diethylstilbestrol, ketoconazole, abiraterone, enzalutamide) and non-steroidal
anti-androgens (such as bicalutamide, flutamide or nilutamide).; d.) Immune
modulators, cytokines or vaccines for the management of cancer or non-cancer-related
illnesses.;

2. (Exclusion Criteria #2 Cont.): e.) Any non-oncology vaccine therapy used for
prevention of infectious diseases (for up to one month before any dose of
ipilimumab).; f.) Any other investigational product.

3. Use of controlled schedule III controlled substances for cancer-related pain control.

4. Autoimmune disease: Patients with a history of inflammatory bowel disease (including
Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid
arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus
or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this
study.

5. Any underlying medical or psychiatric condition, which in the opinion of the
Investigator, will make the administration of study drug hazardous or obscure the
interpretation of AEs, such as a condition associated with frequent diarrhea.

6. Patients with known brain metastases.

7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, history of congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

8. Known HIV, Hepatitis B, or Hepatitis C.

9. Untreated symptomatic spinal cord compressions.

10. Other malignancies requiring active therapy or known to be associated with altered
immune response.

11. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI
obstruction and abdominal carcinomatosis which are known risk factors for bowel
perforation.