Inclusion Criteria:
1. Ability to understand and the willingness to sign a written informed consent document.
2. Age ≥ 18 years
3. Histologic evidence of adenocarcinoma of the prostate who are deemed candidates for
radical prostatectomy. Variants such as neuroendocrine components or ductal carcinoma
are allowed. Pure small cell carcinoma is not allowed.
4. At least two intermediate risk factors or classified as high risk or very high risk
clinically localized disease as defined by NCCN guidelines:
a. Very high risk. At least one of the following: i. cT3b-T4 disease ii. Primary
Gleason pattern of 5 iii. More than 4 cores with a Gleason sum of 8, 9 or 10 b. High
risk: At least one of the following: i. cT3a disease ii. Gleason sum of 8, 9 or 10
iii. PSA ≥ 20 ng/ml c. At least two of the following intermediate risk factors: i.
cT2b or cT2c disease ii. Gleason sum of 7 (either 3+4 or 4+3) iii. PSA 10-20 ng/ml
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (See Appendix A)
6. International Prostate Symptom Score (IPSS) of <18 within 28 days of Cycle 1 Day 1
7. Adequate normal organ and marrow function as defined below by the following criteria
within 10 days prior to first dose of study treatment. :
1. Hemoglobin ≥ 9.0 g/dL
2. Absolute neutrophil count (ANC ≥1.5 x 109/L)
3. Platelet count ≥100 x 109/L
4. Serum bilirubin ≤ 1.5 x Institutional Upper Limit of Normal (ULN)
5. AST/SGOT and ALT/SGPT ≤ 2.5 x ULN
6. Measured creatinine clearance (CL) >50 mL/min
8. Patient 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.
Exclusion Criteria:
1. History of or known bone, brain, visceral, or soft tissue metastasis, including lymph
nodes based on standard of care imaging with CT or pelvic MRI showing no LNs greater
than 1.5cm and bone scan showing no evidence of bone metastasis.
2. Prior pelvic radiation or prostate cryotherapy or high-intensity focused ultrasound
(HIFU)
3. Any prior treatment with PD-1 or PD-L1 checkpoint inhibitors or with an agent directed
to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137,
PD-L2).
4. Is currently participating in or has participated in a study of an investigational
agent (or used an investigational device) within 4 weeks prior to the first dose of
study treatment.
a. Note: Participants who have entered the follow-up phase of an investigational study
may participate as long as it has been 4 weeks after the last dose of the previous
investigational agent.
5. Prior therapy for prostate cancer
a. Exceptions: Previous alpha-reductase inhibitor use allowed IF patient has not been
taking for at least 30 days prior to study treatment initiation, OR if alpha reductase
inhibitor was not used as a primary treatment of prostate cancer and the PSA on
alpha-reductase inhibitor remains within eligibility when doubled. ]
6. Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy
for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related
conditions (e.g., hormone replacement therapy) is acceptable.
7. Has active autoimmune disease that has required systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids beyond prednisone 10mg
daily or equivalent, or other immunosuppressive drugs). Replacement therapy (eg.,
thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or
pituitary insufficiency, etc.) is not considered a form of systemic treatment.
8. Presence of a condition requiring chronic steroid use (equivalent to >10 mg of
prednisone daily) or other immunosuppressive drugs (i.e., for organ transplant). The
following are exceptions to this criterion:
1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra
articular injection)
2. Steroids as premedication for hypersensitivity reactions (e.g., CT scan
premedication)
9. Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
situations that would limit compliance with study requirement, substantially increase
risk of incurring AEs or compromise the ability of the patient to give written
informed consent
10. History of another primary malignancy except for:
c. Malignancy treated with curative intent and with no known active disease ≥5 years
before the first dose of IP and of low potential risk for recurrence d. Adequately
treated non-melanoma skin cancer or lentigo maligna without evidence of disease e.
Adequately treated carcinoma in situ without evidence of disease
11. History of allogenic stem cell transplant
12. History of active primary immunodeficiency
13. Known history of human immunodeficiency virus
14. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is
detected) infection.
15. Has received a live vaccine within 30 days prior to the first dose of study drug.
Examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection
are generally killed virus vaccines and are allowed; however, intranasal influenza
vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
16. Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.
17. Any condition which, in the opinion of the investigator, would preclude participation
in this trial
