*Credentialing required. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED:
SJMH, Livonia,Sparrow, SJMO, Saginaw

-Patients post-prostatectomy with baseline Gleason ? 7 (per prostatectomy pathology)
-Baseline PSA nadir ? 0.2 ng/ml
-Pathologically proven diagnosis of adenocarcinoma of the prostate. Prostatectomy must have been performed within 365 days (1 year) prior to Step 1
-Prior androgen deprivation therapy (LHRH agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for ? 90 days duration.
-Pathologically lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown
-Any pT-stage is eligible.
-ECOG PS must be 0-1
-Must NOT have clinical or radiologic evidence of metatstatic disease
-Must not have prior RT that would result in overlap of fields
-Must not have prior systemic chemotherapy for this cancer
-Prior whole gland ablative therapy is not allowed

CREDENTIALING REQUIRED. *Please check your site's credentialing status.
CURRENT SITES CREDENTIALED:
Genesys Hurley, Livonia, SJMH, Sparrow, SJMO

-Adenocarcinoma of the prostate treated primarily with radical prostatectomy
-pathologic T-classifications: pT2 or pT3. Patients with positive surgical margins are eligible
-pathologic N-classifications: pN0, pNX.
-No clinical evidence of regional lymph node metastasis.
-A post-radical prostatectomy study entry PSA =45 days after prostatectomy and within 30 days prior to Step 1, < 2.0 ng/mL.
-No evidence of a local recurrence in the prostate fossa based on a digital rectal examination (DRE)
-No evidence of bone metastases
-Zubrod Performance Status 0-1
-Must not have post-prostatectomy PSA nadir = 0.2 ng/mL AND Gleason = 7
-Must not be pT2 with a negative surgical margin and PSA < 0.1 ng/mL
-Must not have had androgen deprivation therapy started prior to prostatectomy for > 6 months
-Must not have had androgen deprivation therapy started after prostatectomy for > 6 weeks
-Must not have had neoadjuvant chemotherapy before or after prostatectomy.
-Must not have had prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT volumes.

 **ePRO training required prior to first patient enrollment.** 

CREDENTIALING REQUIRED. Please check your site's credentialing status.

CURRENT SITES CREDENTIALED: Trinity Health Medical Center (Ann Arbor, Brighton, Canton), Chelsea, Livonia, Sparrow

Eligibility Criteria:

3.1 Eligibility Criteria (13-AUG-2024) A patient cannot be considered eligible for this study unless ALL of the following conditions are met.

3.1.1 Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted;

3.1.2 Any T-stage is eligible (AJCC 8th ed);

3.1.3 Appropriate stage for study entry based on Fluciclovine F-18 PET scan (FACBC, Axumin) F-18 PSMA PET (PyLarify) scan, Gallium-68 PSMA PET scan, flotufolastat F-18 PSMA PET scan (Posluma), or C-11 or F-18 Choline PET within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease (see Appendix IV for molecular imaging guidelines). For patients with PSA <0.20 ng/mL at time of registration, PET scan is recommended but not required.

3.1.4 Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen or nodal disease on imaging at time of recurrence (including external iliacs, internal iliacs, and/or obturator nodes); peri-prostatic and peri-rectal nodes can also be considered regional lymphadenopathy and are allowed;

3.1.5 History/physical examination within 90 days prior to registration;

3.1.6 Age ≥ 18;

3.1.7 ECOG Performance Status of 0-1 within 90 days prior to registration;

3.1.8 Detectable PSA after radical prostatectomy. Detectable PSA is defined as serum PSA >0 ng/mL at least 30 days after prostatectomy (see Section 3.1.9). 

3.1.9 Patients who have already started on post-prostatectomy GnRH agonist/antagonist for ≤ 180 days prior to registration are eligible (Note: patients who started on an oral antiandrogen are eligible if started ≤ 180 days and stopped prior to registration);

3.1.10 Adequate hematologic function within 90 days prior to registration defined as follows: • Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors • Platelet count ≥100,000 x 109 /µL independent of transfusion and/or growth factors

3.1.11 Serum potassium ≥3.5 mmol/L within 90 days prior to registration;  

**PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELIGIBILITY LIST** 

Site staff must complete ePRO online training in Rave prior to the first patient enrollment.

** Substudy Closureof Accrual for Arms 1 and 2: Health-Related Quality of Life (QOL)**

**Effective 09/10/2024 the intensification cohort (Groups 3 and 4) is CTA** 

*DTL Required- Physicians must sign toxicity grid

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: SJMH (AA, Brighton, Canton, Chelsea), Livonia, Sparrow, GenHur, Saginaw

**SJMH/Livonia will not be participating in the EBRT Treatment Technology: Proton beams portion of this trial**

CONSENT NOTE: Patients consented prior to V. 09/24/2021 include Abiraterone on Arm 4. The study was amended after amendment #1 to remove abiraterone from protocol treatment for all new patients. Those patients enrolled prior to amendment #1 have the choice to continue abiraterone. All patients consented after this amendment must use the consent form not containing abiraterone in the name. 

Eligibility Criteria  

Prior to Step 1 Registration

-Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration;

- High-risk disease defined as having at least one or more of the following:

• PSA>20 ng/mL prior to starting ADT

• cT3a-T4 by digital exam or imaging (AJCC 8th Ed.)

• Gleason Score of 8-10

• Node positive by conventional imaging with a short axis of at least 1.0 cm 

Appropriate stage for study entry based on the following diagnostic workup:

• History/physical examination within 120 days prior to registration;

• Bone imaging within 120 days prior to registration; Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or NaF PET within 120 days prior to registration (Negative Na F PET/CT or Negative Axumin or Choline PET or Negative fluciclovine, choline or PSMA PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible.

• CT or MRI of the pelvis within 120 days prior to registration (Negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only.

• Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by >10mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure ≤10mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study.

- Age ≥ 18;

- ECOG Performance Status of 0-2 within 120 days prior to registration;

- Adequate hematologic function within 120 days prior to registration defined as follows:

• Hemoglobin ? 9.0 g/dL, independent of transfusion and/or growth factors

• Platelet count ≥ 100,000 x 109 /µL independent of transfusion and/or growth factors  

Ineligibility Criteria 

 Prior to Step 1 Registration

- Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI);

- Prior systemic chemotherapy within ≤3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration);

- Prior radical prostatectomy;

- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;

- Current use of 5-alpha reductase inhibitor 

 Eligibility Criteria: Prior to Step 2 Randomization

 - Confirmation of Decipher score.

 -Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior.

Ineligibility Criteria-  Prior to Step 2 Randomization:

-   Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration.

**See protocol for full eligibility criteria list** 

**Intensification cohort (Groups 3 and 4) CTA Effective 11/22/2024**

*DTL Required- Physicians must sign toxicity grid

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: SJMH (AA, Brighton, Chelsea, Canton), Sparrow, Genesys, Hurley, Saginaw

**IROC LDR/HDR Brachytherapy treatment at Ann Arbor only** 

Prior to Step 1 Registration the patient must meet all of the following criteria in 3.1 and 3.2. Patients MUST have a confirmation of Decipher score prior to Step 2 Randomization. See section 3.3 and 10.1.1 for more details.

- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration;

- Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria: • Has at least one intermediate risk factor (IRF):

- PSA 10-20 ng/mL

- Clinical stage T2b-c (DRE and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition

- Gleason Score 7 (Gleason 3+4 or 4+3 [ISUP Grade Group 2-3])

• Has ONE or more of the following ‘unfavorable’ intermediate-risk designators:

- >1 IRF

- Gleason 4+3=7 (ISUP Grade Group 3)

- ≥50% of biopsy cores positive*

• Absence of high-risk features, see section 3.2.12

*Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s).

Appropriate stage for study entry based on the following diagnostic workup: • History/physical examination within 120 days prior to registration;

• Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or NaF positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, CT or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities).

• Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.0 cm in short axis and/or if biopsy is negative. Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node <=10mm in short axis, negative biopsy), the patient will still be eligible.

-Age ≥ 18;

- ECOG Performance Status of 0-2 within 120 days prior to registration;

- Non-castrate testosterone level (>50ng/dL) within 120 days prior to registration;

- Adequate hematologic function within 120 days prior to registration defined as follows:

• Absolute Neutrophil ≥ 1,000 cells/mm3

• Hemoglobin ≥ 8.0 g/dL, independent of transfusion and/or growth factors

• Platelet count ≥ 100,000 cells/mm3 independent of transfusion and/or growth factors

- Adequate renal function within 120 days prior to registration defined as follows:

Creatinine Clearance (CrCl) ≥30 mL/min estimated by Cockcroft-Gault Equation: 

CrCl (mL/min) = [140 – age (years)] x weight (kg) 72 x serum creatinine (mg / dL)

For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR≥30 mL/min/1.73m2 will be considered adequate:

GFR = 141 × min(Scr/?, 1)-0.411 × max(Scr/?, 1)-1.209 × 0.993Age × 1.159 [if patient identifies as African American]  

where: Scr is serum creatinine in mg/dL, ? is 0.9 for males, min indicates the minimum of Scr/? or 1, and max indicates the maximum of Scr/? or 1 A calculator for this formula is available at: https://www.niddk.nih.gov/health\u0002information/professionals/clinical-tools-patient-management/kidney-disease/laboratory\u0002evaluation/glomerular-filtration-rate-calculators/ckd-epi-adults-conventional-units

- Adequate hepatic function within 120 days prior to registration defined as follows:

• Total Bilirubin: 1.5 ≤ institutional upper limit of normal (ULN) (Note: In subjects with Gilbert’s syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible).

• AST(SGOT) and ALT(SGPT): ≤ 2.5 × institutional ULN

- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol.

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).

- For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy.  

-The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.

Ineligibility Criteria

-Patients with any of the following conditions are NOT eligible for this study

- Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, HIFU, laser thermal ablation, etc.) for prostate cancer.

- Definitive clinical or radiologic evidence of metastatic disease (M1).

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed.

- Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.

- Previous bilateral orchiectomy.

- Previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed.

- Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration.

- Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration.

-Severe, active co-morbidity defined as follows:

• Current severe or unstable angina;

• New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)

• History of any condition that in the opinion of the investigator, would preclude participation in this study.

- Inability to swallow oral pills.

- High Risk features, which includes any of the following:

• Gleason 8-10 [ISUP Grade Group 4-5]

• PSA>20

• cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]  

*DTL Required- Physicians must sign toxicity grid

CREDENTIALING REQUIRED. Please check your site's credentialing status.

CURRENT SITES CREDENTIALED: SJMH (AA, Brighton, Canton, Chelsea), Livonia, Sparrow

Eligibility Criteria

- Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration.

- Age ≥ 18 years.

- ECOG Performance Status 0-2 within 120 days prior to registration. 

-Prior curative-intent treatment to the prostate, by either:

• External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.

• Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes 

-Must have > 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less

**See Protocol for entire eligibility list!** 

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: SJMH (AA, Brighton, Canton, Chelsea), Livonia, Sparrow, Lehigh Valley

Eligibility Criteria:

Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration;

- Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup:

• History/physical examination within 45 days prior to registration;

• CT/MRI of the chest/abdomen/pelvis within 45 days prior to registration;

- Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>3 factors) (See Appendix I).

-Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

-5 Patients with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor.

- Patient not recommended for or refused immediate cytoreductive nephrectomy.

- Candidate for standard of care therapy with either IO-IO or IO-VEGF combination regimen.

- Primary renal tumor measuring 8 cm or less in anterior to posterior dimension only on axial imaging. - Age ≥ 18;

-Karnofsky Performance Status > 60 within 45 days prior to registration;

- Adequate hematologic function within 45 days prior to registration defined as follows:

• Hemoglobin > 8 g/dL (transfusions are allowed)

• Platelet count > 50,000/mm3

• ANC > 1500/mm3

- Adequate renal function within 45 days prior to registration defined as follows:

• Calculated (Calc.) creatinine clearance > 30 mL/min.

Adequate hepatic function within 45 days prior to registration defined as follows:

• Total bilirubin < 1.5 x upper limit of normal (ULN). (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)

• Aspartate aminotransferase and alanine aminotransferase (AST and ALT) < 3 x upper limit of normal (ULN) or < 5 x ULN if hepatic metastases present.

- Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not required for entry into protocol.

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 3.1.16 Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.

- The patient must agree to use a highly effective contraception, including men with vasectomies if they are having sex with a woman of childbearing potential or with a woman who is pregnant, while on study drug and for 6 months following the last dose of study drug. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Please see section 9 for more details.

- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: Trinity Health (AA, Canton, Chelsea, Brighton, Livonia), Genesys, Hurley, Saginaw, Sparrow

Eligibility Criteria:

3.2.1 Documentation of Disease Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer.

3.2.2 Definition of Disease 1. High-risk disease defined as having at least one or more of the following: o cT3a-T3b by digital exam or imaging (AJCC 8th Ed.) Note: cT4 by imaging or on digital rectal exam is not allowed.

o The patient’s PSA value >20 ng/mL prior to starting ADT Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors.

o Gleason Score of 8-10 o Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm 2. Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan. 3. No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative PSMA PET is an acceptable substitute.

3.2.3 Age ≥ 18

3.2.4 ECOG Performance Status of 0-2

3.2.5 Prior Treatment

• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;

• No prior radical prostatectomy;

• Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease in 3.2.2.

3.2.6 Co-Enrollment with NRG-GU009 (ONLY Applies to Patients enrolled in NRG\u0002GU009) Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy. For details, see Section 5.4.  

 **PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELGIBILITY LIST**

No new sites are allowed to participate in this study per the sponsor effective 5/22/17.
CURRENT SITES CREDENTIALED: Lehigh    

-Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer with documented disease progression (disease not amendable to curative therapy). NOTE: Patients with mucinous histology are NOT eligible.

-All patients must have measurable disease
-Patients are allowed to have received up to three prior cytotoxic regimens for treatment of their disease. They must have had one prior platinum-based chemotherapeutic regimen.
-Patients are allowed to have received, but are not required to have received, one or two cytotoxic regimens for management of recurrent or persistent disease. If two cytotoxic regimens had been received for management of recurrent or persistent disease, one of these regimens would have had to contain either a platinum or a taxane agent. (For the purposes of this study PARP inhibitors given for recurrent or progressive disease will be considered cytotoxic.) 
-ECOG PS must be 0-2
-Patients must have progressed < 12 months after completion of their last platinum-based chemotherapy
-Patients must not have had prior therapy with nivolumab or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways
-Patients must not have CNS disease
-Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.
-Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration