Pembrolizumab for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carcinoma+8 More
Pembrolizumab - Biological
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two drugs to treat prostate cancer that has spread. The first drug, 177Lu-PSMA-617, is a radioactive agent that targets and kills cancer cells. The second drug, pembrolizumab, is an immunotherapy that helps the body's immune system attack the cancer. The combination of these two drugs may be more effective at treating prostate cancer than either drug alone.

Eligible Conditions
  • Carcinoma
  • Stage IVA Prostate Cancer
  • Stage IV Prostate Cancer
  • Castration Levels of Testosterone
  • Castration-Resistant Prostate Carcinoma
  • Malignant Neoplasms
  • Adenocarcinoma
  • Stage IVB Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 2 years

Month 6
Radiographic progression-free survival (rPFS) rate
Year 2
Lesion-specific response rate by baseline PSMA avidity on gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)
Percent change in T cell repertoire, circulating T cell subsets, tumor infiltrating lymphocytes (TILs), and tumor PD-L1 expression by immunohistochemistry
Prostate-specific antigen (PSA) response rate
Year 2
Median duration of response by RECIST 1.1
Year 2
Overall survival
Year 2
Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (Part B)
Year 1
Recommended phase 2 dose (Part A)
Up to 2 years
Median PSA progression-free survival
Up to 90 days
Frequency and severity of adverse events as defined by CTCAE version 4.0

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Schedule 3 (lutetium Lu 177-PSMA-617, pembrolizumab)
1 of 3
Schedule 2 (lutetium Lu 177-PSMA-617, pembrolizumab)
1 of 3
Schedule 1 (lutetium Lu 177-PSMA-617, pembrolizumab)
1 of 3

Experimental Treatment

43 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1

Schedule 3 (lutetium Lu 177-PSMA-617, pembrolizumab)Experimental Group · 2 Interventions: Pembrolizumab, Lutetium Lu 177-PSMA-617 · Intervention Types: Biological, Drug
Schedule 2 (lutetium Lu 177-PSMA-617, pembrolizumab)Experimental Group · 2 Interventions: Pembrolizumab, Lutetium Lu 177-PSMA-617 · Intervention Types: Biological, Drug
Schedule 1 (lutetium Lu 177-PSMA-617, pembrolizumab)Experimental Group · 2 Interventions: Pembrolizumab, Lutetium Lu 177-PSMA-617 · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Prostate Cancer FoundationOTHER
38 Previous Clinical Trials
2,050 Total Patients Enrolled
7 Trials studying Carcinoma
408 Patients Enrolled for Carcinoma
University of California, San FranciscoLead Sponsor
2,266 Previous Clinical Trials
11,467,288 Total Patients Enrolled
29 Trials studying Carcinoma
7,668 Patients Enrolled for Carcinoma
National Cancer Institute (NCI)NIH
13,005 Previous Clinical Trials
41,301,884 Total Patients Enrolled
1,309 Trials studying Carcinoma
389,843 Patients Enrolled for Carcinoma
Rahul Aggarwal, MDPrincipal Investigator - University of California, San Francisco
UCSF Medical Center at Parnassus
Northwestern University Medical Sch (Medical School)
18 Previous Clinical Trials
1,200 Total Patients Enrolled
4 Trials studying Carcinoma
274 Patients Enrolled for Carcinoma

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
criterion We will not allow histologically confirmed prostate adenocarcinoma that has turned into small cell neuroendocrine prostate cancer
A patient must have at least three lesions on their baseline 68Ga-PSMA-11 PET scan that are considered to be avid, meaning that they have a maximum standardized uptake value (SUVmax) value greater than liver.
The PCWG3 defined metastatic prostate cancer as cancer that had spread beyond the prostate gland and had continued to grow, even after being treated with hormones that usually stop prostate cancer from growing.
for creatinine < 25 mg The patient's serum creatinine is less than 1.5 times the upper limit of normal, or their estimated glomerular filtration rate is greater than 50 ml/min using the Cockcroft-Gault equation or 24 hour urine collection for creatinine less than 25 mg.
Someone who has progressed on at least one of the second generation androgen signaling inhibitors, which include abiraterone, apalutamide, darolutamide, or enzalutamide.
is required A person's absolute neutrophil count must be greater than 1.5 x 10^9/L in order to donate bone marrow.
A person's hemoglobin level is considered to be high if it is 9.0 g/dL or more.
A platelet count that is over 100,000/microliter is considered high.
I am able and willing to comply with study procedures and provide signed and dated informed consent.
The study will enroll patients with a castrate level of serum testosterone at study entry (< 50 ng/dL)

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.