In a nutshell
This clinical trial is evaluating the safety and effectiveness of an experimental treatment, BXCL701, in combination with pembrolizumab (Keytruda) for people with small cell neuroendocrine prostate cancer (SCNPCa). The main outcome to be measured will be the response rate to the study treatment.
The details
Prostate cancer is the most common cancer in men. Most prostate cancers are classified as adenocarcinomas. These respond to male sex hormones called androgens (such as testosterone) and can be monitored through prostate-specific antigen (PSA) levels in the blood.
However, Small Cell Neuroendocrine Prostate Cancer (SCNC) is a more aggressive type of prostate cancer and it does not respond to androgens and cannot be monitored through PSA levels. Some patients develop SCNC after their adenocarcinoma stops responding to hormonal therapy and spreads to other tissues. Current treatments for SCNC often involve chemotherapy, surgery, and/or radiotherapy. However, new treatments are needed for this type of cancer.
Pembrolizumab (Keytruda) is an antibody-based drug that helps the immune system attack cancer cells. It has been approved for the treatment of several types of cancer. BXCL701 is a dipeptidyl peptidase (DPP) inhibitor. DPP is a protein involved in the immune function. By blocking DPP, BXCL701 works by boosting the immune system. Experimental studies have shown that pembrolizumab and BXCL701 have synergistic actions.
This study is evaluating the safety and effectiveness of BXCL701 combined with pembrolizumab in people with SCNC. The main outcome evaluated will be the response to study treatment.
Who are they looking for?
This trial is recruiting about 40 participants with Small Cell Neuroendocrine Prostate Cancer (SCNC). Participants with metastatic or locally advanced prostate cancer that is progressing or has stopped responding to at least one line of whole body (systemic) therapy such as hormonal therapy or chemotherapy (metastatic castration-resistant prostate cancer) can also be included.
To be included in the trial, participants must have adequate kidney, liver and bone marrow function tests and must agree to use effective birth control measures during the study and up to 6 months after the last dose of study drugs.
People cannot participate if they have had more than 2 lines of chemotherapy or if they have received immunotherapy such as pembrolizumab. People with any other type of active cancer, with serious heart, lung or brain conditions cannot participate. People with an autoimmune disease requiring corticosteroids with uncontrolled infections including HIV or Hepatitis B or C will also be excluded from the trial. People who are being treated with DPP4 inhibitors (i.e., gliptins) are excluded from the trial.
How will it work
There will be 2 stages in this study. During the first stage, some of the participants will receive 0.6 mg of BXCL701 tablets every day for days 1 to 14 of a 21-days cycle. Participants will also receive an intravenous infusion of 200 mg of pembrolizumab on day 1 of each 21-days cycle. After the dose of BXCL701 has been determined, the second stage will begin. During the second stage more participants will be recruited. All participants will take BXCL701 tablets every day on days 1 to 14 and a pembrolizumab infusion on day 1 of each 21-days cycle. This study treatment will continue until disease progression or unacceptable side effects.
All participants will attend study center visits and will be evaluated using imaging, blood, and urine tests to measure response to study treatment. Survival, duration of response, and side effects will also be assessed.
Clinical trial locations
| Type: | Interventional |
| Participants: | 135 |
| Study ID: | NCT03910660 |
| Sponsor: |
