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Northwestern University Feinberg School of Medicine
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Polsky Urologic Cancer Institute

Clinical Trials

Clinical trials are research studies that help doctors find new and better ways to prevent and treat cancer. Almost every cancer treatment that is saving lives today is the result of a clinical trial. Search below to find clinical trials related to urologic cancer, visit the About Clinical Trials page on the Lurie Cancer Center website to learn more and talk with your doctor to decide if a clinical trial is right for you.

Trials
The Genetics of Prostate Cancer in Active Surveillance
Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
1. Patients diagnosed with prostate cancer
2. Patients with Gleason ≤ 3+3 prostate cancer
3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00059221
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Stockdale, Jazmine +1 312 694 2417
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NU 15U06: A Phase 1 Dose-Escalation Study of Intravesical Pembrolizumab and Bacillus Calmette-Guerin (BCG) in Subjects with High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerabili…
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of Pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the Pembrolizumab. Overview Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body‰Ûªs immune system to work against tumor cells. Pembrolizumab is FDA approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the USFDA for bladder cancer, hence it is considered an investigational agent for this disease. Description of Treatment All study participants will take the same study drug, Pembrolizumab. Pembrolizumab will be given intravesically through urethra. With intravesical therapy, doctor administers the drug directly into the bladder (through a catheter), rather than giving it by mouth or injecting it into a vein. During the first six weeks of therapy, one will also receive treatment with BCG as a standard of care. We expect that one will receive treatment for up to 1 year or until your disease gets worse (whichever occurs first). After completing treatment, the study team will continue to watch you for side effects for at least 30 days. The study team will also continue to check periodically to see how you are doing until your disease returns.
Some of the eligibility criteria include:

- Participants must have a recurrent, high or low risk non-muscle-invasive bladder carcinoma.
- Participants must (be BCG refractory) have received at least one 6-week course of BCG induction plus 1 maintenance dose, OR 2 full 6-week courses of induction BCG treatment.
- Participants must be 18 or older.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02808143 STU00202754
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Study Coordinator 312 695 1102
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NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in p…
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
Some of the eligibility criteria include:

- participants must have been diagnosed with prostate cancer that is metastatic (has spread outside of the prostate region) and castration-resistant (means the cancer is still growing even when testosterone levels are close to zero)
- participants must be males 18 years of age or above

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Hussain, MahaHussain, Maha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03012321 STU00203960
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Study Coordinator 312 695 1102
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The Molecular Markers of Bladder Cancer
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
Meeks, Joshua JMeeks, Joshua J
STU00204352
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312 695 8146
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(xIRB NCI CIRB) SWOG 1602: A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
The purpose of this study is to test two things:• Compare any …
The purpose of this study is to test two things:• Compare any good and bad effects of using the Tokyo-172 version of BCG with thecurrently used BCG LIVE (TICE® BCG) version of BCG on people with bladdercancer receiving BCG in the bladder. The study will be considered successful ifapproximately the same number of patients who receive the different treatments arefree from high grade recurrence of their bladder cancer after one year of treatment.• Using the Tokyo-172 version of BCG, compare any good and bad effects of adding aBCG vaccination (given under the skin) in addition to placing BCG in only thebladder. The study will be considered successful if the vaccination results in an 8%improvement in the number of patients who are free from high grade recurrence oftheir bladder cancer after one year of treatment.
Some of the eligibility criteria include: - Participants must have high grade bladder cancer thathas not entered the muscle - Participants must be 18 or older - Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03091660 STU00205010
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Study Coordinator 312 695 1102
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(xIRB NCI CIRB) ECOG-ACRIN 8143 A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Nivolumab is a drug that may help stimulate one’s immune system to attack any cancer cells that may rem…
Nivolumab is a drug that may help stimulate one’s immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent cancer from returning but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for kidney cancer that has been removed but is at risk for coming back. The study drug, nivolumab, is already FDA-approved for participants who have kidney cancer that has spread outside of the kidney to other organs or lymph nodes. The use of nivolumab in this study is investigational (not approved by the FDA) for early stages of cancer where we do not know for sure if the disease has spread outside of the kidney. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long participants are able to live without any signs or symptoms of cancer compared to the usual approach.
  • Participants must have Renal Cell Cancer
  • Participants must be 18 or older
  • Participants must have disease confirmed by biopsy
Sosman, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03055013 STU00205209
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Study Coordinator 312 695 1102
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NU JH17U01: Overcoming drug resistance in metastatic castration-resistant prostate cancer with novel combination of TGF-β receptor inhibitor LY2157299 and enzalutamide: a randomized multi-site phase II study

This research is being done to test the effectiveness (anti-tumor activity) and safety of…

This research is being done to test the effectiveness (anti-tumor activity) and safety of combining enzalutamide with LY2157299 for the treatment of men with advanced castrate-resistant prostate cancer.

Enzalutamide blocks testosterone production in the body to slow or stop the growth of prostate cancer cells. Enzalutamide (Xtandi®) is approved by the FDA for the treatment of patients with advanced castrate resistant prostate cancer who have received chemotherapy.

LY2157299 is an investigational drug that inhibits a growth factor that is believed to play a role in the spread of the cancer. The use of LY2157299 in this research study is investigational. The word “investigational” means that LY2157299 is not approved for marketing by the Food and Drug Administration (FDA).

You may be eligible for this research study if you are a man with advanced castrate resistant prostate cancer.

Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00000417 STU00205208
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Study Coordinator 312 695 1102
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DRUG CA209-914: A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

The purpose of this study is to test the effectiveness (how well…

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug combination of nivolumab (also known as BMS-936558) and ipilimumab (also known as BMS-734016) in subjects with localized kidney cancer that have had their tumors completely removed but are at risk of having their cancer return.

Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells.

OPDIVO® (nivolumab) is approved for the treatment of certain types of cancer, including skin, kidney, blood, and lung, in multiple countries including the United States, the European Union, and Japan. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. The combination of nivolumab (Opdivo™) and ipilimumab (Yervoy™) is also approved by the US FDA for the treatment of advanced kidney cancer that has spread to other parts of the body and by the US FDA and the EMA for the treatment of metastatic melanoma.

You may be eligible for this research study if you have kidney cancer and have had your tumors completely removed but are at risk of having your cancer return.

Sosman, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03138512 STU00205491
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Study Coordinator 312 695 1102
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Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the inter…
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied. The Food and Drug Administration (FDA) has approved Nivolumab as treatment for advanced renal cell carcinoma, however discontinuation of nivolumab and the combination with Ipilimumab are investigational. Nivolumab is an antibody (type of human protein) drug that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is also an antibody that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is FDA approved for the treatment of melanoma (skin cancer) and has been previously studied in renal cell cancer. Specifically, this study will look at the use of these treatments based on how your disease responds to the treatment. Both of these study drugs are given by IV (intravenous) through a vein. About 12 people are expected to participate in this research study here at Northwestern University out of 160 people in the entire study nationally.
Some of the eligibility criteria include:
• Participants must be 18 or older.
• Patient must have the ability to understand and sign an approved informed consent form (ICF).
• Patient must have a confirmed diagnosis of advanced Renal Cell Carcinoma (RCC).
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Sosman, JeffreySosman, Jeffrey
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03117309 STU00205969
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Study Coordinator 312 695 1102
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PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and ti…
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
Schaeffer, EdwardSchaeffer, Edward
NCT03392181 STU00205957
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Khawaja, Faizan 312 694 2417
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(xIRB) NCI 9767: An Open Label, Multicenter, Single arm Phase II study to evaluate the Activity and Tolerability of the novel mTOR Inhibitor, MLN0128 (TAK-228), in patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the urothelial tract whose tumors harbor a TSC1 and/or TSC2 mutation.
The purpose of this study is to test any good and bad effects of the study drug called MLN0128 (TAK-228). This study is being done to see if MLN0128 (TAK-228) is effective in treating this type of cancer.
• Participants must be 18 years or older
• Participants must have a urinary tract cancer that has spread because the cancer has a mutation in TSC1 and/or TSC2 genes.
• Participants must have already been treated with chemotherapy, but their disease is still growing
Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03047213 STU00206603
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Study Coordinator 312 695 1102
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(xIRB NCI) ECOG ACRIN 8153: Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel(also known as Jevtana®…
The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel(also known as Jevtana®) with the usual approach of the hormonebased therapy abiraterone acetate (also known as Zytiga®) in combination with prednisone on patients with advanced prostate cancerthat have already undergone treatment with hormone therapy and the chemotherapydrug docetaxel.

· Participants must be 18 years or older

Participants have beendiagnosed with prostate cancer that has spread, and is able to grow even though drugsor other treatments to lower the amount of male sex hormones are being used tomanage the cancer.
VanderWeele, DavidVanderWeele, David
NCT03419234 STU00207949
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Study Coordinator 312 695 1102
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(xIRB NCI) Alliance A031501: Phase III Randomized Adjuvant Study Of MK-3475 (pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carconima (AMBASSADOR) versus Observation

· · Had surgery to remove bladder cancer which is inthe deep muscle of the bladder wall (called mus…

· · Had surgery to remove bladder cancer which is inthe deep muscle of the bladder wall (called muscle-invasive bladder cancer) orurothelial cancer (in the urine collection area)

Note: This is only a partial list of eligibilitycriteria. Please contact the Robert H. Lurie Comprehensive Cancer Center ofNorthwestern University for complete screening information if you areinterested in this clinical trial.

The purpose of this study isto compare any good and bad effects of using a drug called MK-3475(pembrolizumab) after the removal of your muscle invasive bladder cancer orurothelial cancer. MK-3475 is a drug that uses a person’s own immune system totreat cancer. This study will allow researchers to know whether treatment withMK-3475 is better, the same, or worse than the usual approach. To be better,the MK-3475 should increase life by 9 months or more, compared to observationalone. The use of MK-3475 could prevent your cancer from returning but it couldalso cause side effects. This immunotherapy drug, MK-3475, is alreadyFDA-approved for use in other types of cancers, but for your type of cancer itis considered experimental. There will be about 739 people taking part in thisstudy.

VanderWeele, DavidVanderWeele, David
NCT03244384 STU00208176
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Study Coordinator 312 695 1102
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