Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
A Phase Ib Study Evaluating the Safety and Tolerability of Sipuleucel-T (Sip-T) in Combination With N-803 in Patients With Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 8 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients will receive treatment for up to 8 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and side effects of sipuleucel-T (Sip-T) with N-803 to find a dose for future studies. It is for adults with prostate cancer that has spread and resists treatment that blocks male hormones. Treatment lasts up to 8 weeks.
This phase Ib single-center open-label de-escalation study uses a modified 3+3 design to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of standard of care Sip-T and N-803 in patients with metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Patients will receive treatment for up to 8 weeks.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, with prostate adenocarcinoma confirmed by a tissue or cell test.
- Cancer has spread to other parts of the body, confirmed by a scan or biopsy.
- Have had surgery to remove the testicles or medicine to lower testosterone, with a testosterone level of 50 ng/dL or less.
- Can receive Sip-T as standard care.
- Side effects from past treatment have returned to normal or are mild, unless they are stable with care or not medically important.
- Can care for yourself and are out of bed or a chair for at least half of your waking hours.
- Blood counts, liver tests, and kidney tests meet study limits. PSA, a blood marker for prostate cancer, is 200 ng/mL or less.
- Can understand and agree to join by signing a consent form, or have a legally authorized person give consent.
Who can't join
- Cancer is growing quickly or causing symptoms, as judged by the study doctor.
- Received immune treatment or whole-body radiation treatment in the past 6 months, or have ever received Sip-T. Prior radiation to specific areas is allowed as listed in the study rules.
- Take medicines that suppress the immune system, except allowed steroids, or are receiving another experimental treatment or imaging drug. Prednisone at 10 mg daily or less and steroids used on skin, inhaled, or injected into joints are allowed.
- Cancer has spread to the brain or the space around it, unless treated and stable for at least 4 weeks. Surgery wounds must be healed, with no nervous system symptoms or steroid use at the first study dose.
- Have had an allergic reaction to Sip-T, N-803, similar substances, or other study drugs.
- Have an uncontrolled illness, such as an active infection or certain heart problems. People with heart disease or past heart-damaging treatment must meet the study's heart function limit.
- Have HIV without effective treatment and an undetectable virus level for at least 6 months.
- Have chronic hepatitis B with virus still detected while on treatment; hepatitis C that is not cured, unless on treatment with no virus detected; or uncontrolled hepatitis A. These viruses can harm the liver.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Histologically or cytologically confirmed prostate adenocarcinoma. * Imaging- or biopsy-proven metastatic disease. May have any type or location of metastases (bone, lymph node, visceral). * Prior treatment must include either orchiectomy or luteinizing hormone-releasing agonist or antagonist treatment with documented testosterone ≤ 50 ng/dL. * Eligible for standard of care Sipuleucel-T. * Recovery to baseline or ≤ grade 1 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and/or stable on supportive therapy. * At least 18 years of age. * ECOG performance status ≤ 2 * Adequate bone marrow and organ function as defined below: * Absolute neutrophil count ≥ 1,500 K/cumm without granulocyte colony-stimulating factor support * Platelets ≥ 100,000 K/cumm without transfusion * Hemoglobin ≥ 10.0 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT) and ALT(SGPT) ≤ 2.5 x IULN * Calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault * PSA ≤ 200 ng/mL. * Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants Exclusion Criteria: * Rapidly progressing disease or symptomatic prostate cancer as assessed by the investigator. * Prior immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) within the 6 months prior to enrollment. * Prior systemic radiotherapy (such as Ra-223, Lu177-PSMA) within the 6 months prior to enrollment. Prior palliative radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment is allowed. Prior definitive radiation therapy for localized prostate cancer is allowed. * Prior exposure to Sipuleucel-T. * Ongoing systemic immune suppression (oral steroids equivalent to 10 mg daily prednisone or less are allowed; topical, inhaled, and intra-articular steroids are allowed). * Currently receiving any other investigational therapeutic or imaging agents. * Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or N-803 or other agents used in the study. * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a 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 Function Classification; to be eligible for this trial, patients should be a class 2B or better. * HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection. * Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection. * History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection. * Uncontrolled infection with hepatitis A.
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Russell K Pachynski, M.D. · Study contact · 314-286-2341 · rkpachynski@wustl.eduRussell K Pachynski, M.D. · Principal investigatorDaniel Thorek, Ph.D. · Principal investigatorJohn Visconti, D.O. · Sub-investigatorMore trials in St Louis