Castrate Resistant Prostate Cancer study: Pembrolizumab vs 177Lu-PSMA-617
Official title Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT05766371
What this study is testing
What is Pembrolizumab?
An investigational IV medicine being studied as a potential treatment for castration‑resistant prostate cancer. It is designed to block the PD‑1 protein on immune cells, helping the immune system recognize and attack cancer cells.
Also referred to as Keytruda.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is looking at the safety and effect of combining pembrolizumab (an immune‑system drug) with 177Lu‑PSMA‑617 (a radiation therapy that targets prostate cancer cells).
- Who it's for
- Men who have metastatic castration‑resistant prostate cancer and whose disease has grown after at least one hormone therapy such as abiraterone, enzalutamide, or apalutamide.
- What's involved
- Participants will receive both pembrolizumab and 177Lu‑PSMA‑617 through clinic visits, along with regular check‑ups and lab tests to monitor their health.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Male participants who are at least 18 years of age on the day of signing informed consent.
- Histologically confirmed prostate adenocarcinoma that is progressive metastatic castration-resistant prostate cancer by Prostate Cancer Clinical...
- Castrate level of serum testosterone at study entry (\< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on...
- At least one Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) (PSMA PET) avid lesion on screening PSMA PET.
- Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or...
You likely can't join if
- De novo small cell neuroendocrine prostate cancer will not be allowed due to putative lower PSMA expression in this tumor subtype.
- Soft tissue lesions (lymph nodes \> 1.5 centimeter (cm) in short axis, visceral/soft tissue lesions \> 1 cm) on screening Computerized tomography...
- Has received other systemic anti-cancer therapies administered within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study...
- Untreated brain metastases at study entry.
- Receipt of prior PSMA-directed radiotherapy.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-Programmed cell death-ligand 2 (PD-L2) agent or with an agent directed to another...
See the full eligibility criteria
Who can join
- Male participants who are at least 18 years of age on the day of signing informed consent.
- Histologically confirmed prostate adenocarcinoma that is progressive metastatic castration-resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria at the time of study entry.
- Castrate level of serum testosterone at study entry (\< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for...
- At least one Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) (PSMA PET) avid lesion on screening PSMA PET. A positive lesion is defined as uptake above background liver.
- Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide.
- Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade \<= 1 (except for any grade alopecia and grade \<= 2 neuropathy).
- Prior radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from start of study treatment on cycle 1, day 1 (C1D1).
- Eastern Cooperative Oncology Group (ECOG) performance status \ = 70%).
- absolute neutrophil count \>=1,500/microliter (mcL)
- platelets \>=100,000/mcL
- hemoglobin \> 9.0 g/dL
- total bilirubin \<= 1.5 x upper limit of normal (ULN). In patients with known or suspected Gilbert's disease, direct bilirubin \<= ULN
- aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \<= 2.5 x institutional ULN (\<= 5 x ULN in patients with liver metastases)
- alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<= 2.5 x institutional upper limit of normal (\<= 5 x ULN in patients with liver metastases)
- creatinine \<= 1.5 x within institutional upper limit of normal OR
- creatinine clearance Glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2, calculated using the Cockcroft-Gault equation or 24 hour urine collection.
- Participants must use appropriate methods of contraception during study treatment and for at least 6 months after last study treatment.
- Participants must provide consent to comply to recommended radioprotection precautions during study.
- Participants willing to undergo a tumor biopsy. Bone or soft tissue lesion is allowed. Note: The biopsy can be waived if there is no safely accessible lesion in the judgement of the treating investigator.
- Last treatment was \> 28 days prior to C1D1.
- No evidence of new/progressive brain metastases is observed on magnetic resonance imaging (MRI) obtained during screening window
- Patient is clinically stable without requirement of steroid treatment for at least 14 days prior to first dose of study treatment on C1D1.
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
- Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of...
- It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
- Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- De novo small cell neuroendocrine prostate cancer will not be allowed due to putative lower PSMA expression in this tumor subtype.
- Soft tissue lesions (lymph nodes \> 1.5 centimeter (cm) in short axis, visceral/soft tissue lesions \> 1 cm) on screening Computerized tomography (CT) that are negative on PSMA PET.
- Has received other systemic anti-cancer therapies administered within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception.
- Untreated brain metastases at study entry.
- Receipt of prior PSMA-directed radiotherapy.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-Programmed cell death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic...
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment on C1D1.
- Receipt of \> 2 lines of prior taxane-based chemotherapy.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a prednisone equivalent dose of \> 10 mg daily or other form of immunosuppressive therapy within 7 days prior to first dose of study drug.
- Has a history of (non-infectious) ≥ grade 2 pneumonitis/interstitial lung disease that required steroids within past 2 years or has current ≥ grade 1 pneumonitis/ interstitial lung disease at the time of study...
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug on C1D1. Note-Administration of a killed vaccine is allowed.
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure.
- Uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months before study entry.
- Clinically significant arrhythmias not controlled by medication. Note: Chronic rate controlled, or paroxysmal atrial fibrillation/flutter is not an exclusion to study participation.
- Prior external beam radiation involving \> 25 percent (%) of bone marrow or within 14 days of start of protocol therapy on C1D1.
- Major surgery within 28 days of study treatment. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study...
- Has an active infection requiring intravenous antibiotics within 7 days prior to C1D1.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Participants who are HbsAg positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study entry
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
- Has a known history of active Bacillus Tuberculosis (TB).
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- History of bleeding diathesis and currently on anti-coagulation therapy that cannot be safely discontinued for the tumor biopsy procedure.
- Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.