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Protocol Details

Phase I/II Study of PROSTVAC in Combination with Nivolumab in Men with Prostate Cancer

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;



Recruitment Keyword(s)



Prostate Cancer

Investigational Drug(s)


Investigational Device(s)



Biological/Vaccine: PROSTVAC-V/F
Drug: Nivolumab

Supporting Site

National Cancer Institute


The immune system is the cells and organs in the body that recognize and fight infection and cancer. The PROSTVAC vaccine might teach the immune system to find and kill certain prostate cancer cells. Nivolumab is a drug that allows the immune system to fight tumors. Itmight help PROSTVAC work better.


To test the safety and effectiveness of the combination of PROSTVAC and nivolumab. To test this for people with castration resistant prostate cancer and then for other people with localized prostate cancer who are candidates for surgical removal of the prostate.


Men ages 18 and older with prostate cancer


Participants will be screened with:

Medical history

Physical exam

Blood and urine tests


Bone scan

CT scan or MRI

Tumor sample. This may be from a previous procedure.

All participants will get a combination of the study drugs over 8 weeks. They will have 1 visit for the initial injection then 3 booster injection / nivolumab infusion visits. Blood will be tested at these visits.

Over the next 4 weeks, some participants will have:

An exam of the large intestine through the rectum.

CT and bone scans

Standard hormonal treatment

Option to continue treatment every 3 weeks if their disease does not get worse. They will be

have scans every 12 weeks.

Other participants will have surgery to remove the prostate in week 9.

Participants will have a safety visit about a month after their last treatment. This will include a physical exam, blood tests, and possibly scans.

If their cancer progresses, participants will leave the study and may enroll in a long-term follow-up study. They will be contacted once a year to ask about their cancer and treatment.

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For the neoadjuvant cohort, patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis. If evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study. For the CRPC lead in cohort, if histopathological documentation is unavailable, a rising PSA and a clinical course consistent with prostate cancer would be acceptable.

-Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of PROSTVAC in combination with nivolumab, ipilimumab or both in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.

-ECOG performance status of 0 or 1.

-Participants must not have other active invasive malignancies within the past 2 years (with the exception of non-melanoma skin cancers) (for CRPC cohort only).

-Participants must be willing to travel to the study site for follow-up visits

-All participants who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of serious adverse reaction to the vaccine.

-The effects of PROSTVAC in combination nivolumab, ipilimumab or both on the developing human fetus are unknown. For this reason men must agree to use adequate contraception (abstinence, vasectomy) or female partner must use (intrauterine device (IUD), hormonal [birth control, pills, injections, or implants], tubal ligation] prior to study entry and for up to 7 months after the last dose.

-Participants must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation.

-Participants must have normal organ and marrow function as defined below:

--hemoglobin greater than or equal to 8 g/dL

--granulocytes greater than or equal to 1,500/mcL

--platelets greater than or equal to 100,000/mcL

--total bilirubin < 1.5 mg/dL (or less than or equal to 3.0 mg/dL in patients with Gilbert syndrome)

--AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal

--creatinine less than or equal to 1.5 X ULN

-For the lead in cohort:

--Castrate testosterone level (<50ng/dl or 1.7nmol /L)

--Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone:

---Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer OR

---PSA progression defined by sequence of rising values separated by >1 week (2 separate increasing values over a minimum of 2ng/ml (PCWG2 PSA eligibility criteria). If participants had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal. For patients on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal.

--Participants must agree to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone agonist/antagonist or bilateral orchiectomy

-For all neoadjuvant cohorts:

--Participants must be a surgical candidate for radical prostatectomy based on standard workup of PSA, biopsy results, and if necessary supplemental imaging.

--Participants must have chosen radical prostatectomy as their definitive treatment of choice for management of their prostate cancer.

--No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent IV contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed.


-Prior splenectomy.

-The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts (Close household contacts are those who share housing or have close physical contact):

--persons with active or a history of eczema or other eczematoid skin disorders

--those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves

--pregnant or nursing women; children under 3 years of age

-Participants should have no evidence, as listed below, of being immunocompromised:

--HIV positivity due to the potential for decreased tolerance and risk for severe side effects.

--Hepatitis B or C positivity.

-Concurrent use of systemic steroids or steroid eye drops. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal, topical or inhaled steroid use is permitted.

-Participants with known allergy to eggs or to compounds with a similar chemical or biologic composition to PROSTVAC, ipilimumab or nivolumab.

-No prior immune checkpoint inhibitors (e.g., anti-CTLA4, anti-PD-1 or anti-PDL1) are allowed.

-Other serious intercurrent illness.

-Participants with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II IV congestive heart failure.

-Participants with significant autoimmune disease that is active or potentially life threatening if activated.

-Participants with clinically significant cardiomyopathy requiring treatment.

-Participants with ongoing toxicities related to prior therapies targeting T cell coregulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody are excluded

-No transfusion of blood or blood products within 2 weeks and no G-CSF or GM-CSF within 2 weeks prior to initiations of experimental therapy.

-Contraindication to biopsy or prostatectomy (for sequential neoadjuvant cohorts only):

--Bleeding disorders

--Artificial heart valve

--PT/PTT greater than or equal to 1.5 in participants not taking anticoagulation. Participants on anticoagulation (e.g. enoxaparin, oral anticoagulants) are eligible regardless of PT/PTT. Prior to biopsy, anticoagulation will be held per standard practice.

-For participants with localized prostate cancer contraindication to MRI:

--Participants weighing >136 kilograms (weight limit for the scanner tables)

--Allergy to MR contrast agent

--Participants with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices

-History of radiation proctitis (for lead-in CRPC cohort only)

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Not Provided

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Principal Investigator

Referral Contact

For more information:

James L. Gulley, M.D.
National Cancer Institute (NCI)
(301) 480-7164

Katherine O. Lee-Wisdom, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N240
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3525

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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