CLINICAL TRIAL

Pembrolizumab/Vibostolimab coformulation for Prostate Cancer

Recruiting · 18+ · Male · Haarlem, Netherlands

This study is evaluating whether a combination of drugs may help treat prostate cancer.

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About the trial for Prostate Cancer

Eligible Conditions
Metastatic Castration Resistant Prostate Cancer (CRPC) · Prostatic Neoplasms

Treatment Groups

This trial involves 10 different treatments. Pembrolizumab/Vibostolimab Coformulation is the primary treatment being studied. Participants will be divided into 10 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Pembrolizumab 200 mg
BIOLOGICAL
+
Etoposide
DRUG
+
Carboplatin
DRUG
Experimental Group 2
Etoposide
DRUG
+
Carboplatin
DRUG
Experimental Group 3
Pembrolizumab/Vibostolimab coformulation
BIOLOGICAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Prednisone
FDA approved
Etoposide
FDA approved
Lenvatinib
FDA approved
Carboplatin
FDA approved

Eligibility

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Prostate Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or receptor activator of nuclear factor kappa-β ligand inhibitor) must be on stable doses for ≥4 weeks prior to first dose of study therapy
Is able to provide tumor tissue from a site not previously irradiated as follows: Cohorts A, E, and G: must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC; Cohort B: must provide an archival tumor tissue sample or tumor tissue from a newly obtained core or excisional biopsy from soft tissue if the lesion is clinically accessible; Cohorts C and D with soft tissue disease: must provide a core or excisional biopsy from a soft tissue lesion if clinically accessible within 1 year of screening and after developing mCRPC and an archival specimen if available; and Cohorts F, H, and I must provide a core or excisional biopsy from soft tissue or a bone biopsy. Participants with bone metastasis only must provide an archival tumor tissue specimen
Must be abstinent from heterosexual intercourse, refrain from donating sperm, or agree to use contraception (unless confirmed to be azoospermic) during the intervention period starting with the first dose of study therapy. The length of time required to continue contraception after the last dose of study intervention for each study intervention is as follows: 7 days for abiraterone acetate and lenvatinib; 30 days for enzalutamide; and 95 days for olaparib, docetaxel, and carboplatin/etoposide. No contraception measures are required during and after the intervention period for MK-7684A
Has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale for Cohorts A and C and a performance status of 0 or 1 for Cohorts B, D, E, F, G, H, and I within 10 days of study start
For Cohort A: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (e.g., abiraterone acetate and/or enzalutamide) are allowed. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to day 1 of Cycle 1
For Cohort B: Has received prior treatment with either abiraterone acetate or enzalutamide (but not both) in the prechemotherapy mCRPC state. Participants in Cohort B must have received at least 4 weeks of either abiraterone or enzalutamide treatment (but not both) who failed treatment or became intolerant of the drug
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Assessed Every 3 Weeks Over the Duration of the Study Which is Estimated to be Approximately 2 Years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Assessed Every 3 Weeks Over the Duration of the Study Which is Estimated to be Approximately 2 Years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pembrolizumab/Vibostolimab coformulation will improve 4 primary outcomes and 8 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years.

ORR Based on PCWG3-modified RECIST 1.1 Assessed by BICR
ASSESSED OVER THE DURATION OF THE STUDY WHICH IS ESTIMATED TO BE APPROXIMATELY 2 YEARS
Time to PSA Progression
ASSESSED OVER THE DURATION OF THE STUDY WHICH IS ESTIMATED TO BE APPROXIMATELY 2 YEARS
Overall Survival (OS)
ASSESSED OVER THE DURATION OF THE STUDY WHICH IS ESTIMATED TO BE APPROXIMATELY 2 YEARS
Composite Response Rate Defined as Any One of the Following: A. Response Based on RECIST 1.1; B. PSA Decrease of ≥50%; or C. Circulating Tumor-cell Count Conversion (Pembrolizumab + Olaparib Cohort Only)
ASSESSED OVER THE DURATION OF THE STUDY WHICH IS ESTIMATED TO BE APPROXIMATELY 2 YEARS
Duration of Response (DOR) Based on PCWG3-modified RECIST 1.1 Assessed by BICR
ASSESSED OVER THE DURATION OF THE STUDY WHICH IS ESTIMATED TO BE APPROXIMATELY 2 YEARS
Radiographic Progression-free Survival (rPFS) Based on PCWG3-modified RECIST 1.1 Assessed by BICR
ASSESSED OVER THE DURATION OF THE STUDY WHICH IS ESTIMATED TO BE APPROXIMATELY 2 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes prostate cancer?

Over half of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s occur in men under 50 who are younger than their fathers, and those men are twice as likely to be diagnosed before the age of 50. This suggests that certain environmental factors are accountable for prostate cancer at all ages. The higher levels of prostate-specific antigen (PSA) observed in men of advanced ages may indicate an increased risk of prostate cancer.

Anonymous Patient Answer

How many people get prostate cancer a year in the United States?

Approx. 6,500 men are confirmed to have prostate cancer each year in the United States, making up approximately 1.3% of all men at risk for having prostate cancer. This number includes 1,100 men with Gleason > or = 8 prostate cancer, 1,000 men with pT1 prostate cancer, and 2,000 men with cN0 prostate cancer.

Anonymous Patient Answer

What are the signs of prostate cancer?

There is usually no one specific sign of prostate cancer. However, the symptoms associated with prostate cancer may lead to its identification and diagnosis early.

Anonymous Patient Answer

What are common treatments for prostate cancer?

A variety of treatments are employed for prostate cancer, including medication, and the use of surgery and other treatment modalities. The most common treatment for prostate cancer depends on the disease stage and the aggressiveness of the tumor. A treatment decision based on the person's condition and needs may also be important.

Anonymous Patient Answer

Can prostate cancer be cured?

In more localized [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s, treatment has improved to a level where treatment can reduce symptoms, prolong survival and prevent cancer death. However, in more aggressive disease the ability to cure prostate cancer has been reduced to near death levels. It seems likely that advances in treatment for aggressive disease will continue, and prostate cancer death will continue to fall. Even though patients are able to live a good life, this will never be the case when treatment is not available. Thus, the treatment of prostate cancer cannot be cured.

Anonymous Patient Answer

What is prostate cancer?

Prostate cancer is currently the 7th-most-common cancer to be diagnosed in men in the United States, accounting for approximately 9.1% of all cases. The vast majority of prostate cancer cases occur in men over 50, which presents many problems in terms of healthcare and patient care. This is also why prostate cancer was selected as a subject for this lecture.\n

Anonymous Patient Answer

What is pembrolizumab/vibostolimab coformulation?

In this first line phase III multicenter trial, PD-1 immune checkpoint antibody, plus vb, did not demonstrate superiority over mb in patients with metastatic melanoma. Pembrolizumab plus vibostolimab in patients with advanced melanoma is currently being investigated in a large international multicenter phase 3 clinical trial (ADEPT-IL2-IL13 or ADEPT trial).

Anonymous Patient Answer

Does pembrolizumab/vibostolimab coformulation improve quality of life for those with prostate cancer?

In this exploratory analysis, prostate cancer patients treated with pembrolizumab/vibostolimab coformulation had less nausea, vomiting, fatigue, and anxiety but no more serious adverse events or pain when compared to monotherapy with pembrolizumab/vibostolimab. Further studies are needed to clarify whether the combination is superior to pembrolizumab/vibostolimab for improving quality of life in prostate cancer patients.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

The average age that men are diagnosed with prostate cancer is approximately 72.4 years. This varies geographically, as the average age of diagnosed prostate cancer is highest in British Columbia at 73 years of age and lowest in Mississippi at 70.7 years.

Anonymous Patient Answer

Who should consider clinical trials for prostate cancer?

The vast majority of men with clinically localized prostate cancer are not likely to benefit from enrollment in a clinical research trial. Physicians should be aware that current research trials are only designed for treatment arms with a high probability of cure. Physicians should refrain from discouraging patients with prostate cancer because they are unlikely to have a cure.

Anonymous Patient Answer

Is pembrolizumab/vibostolimab coformulation safe for people?

These data show the potential for a safer formulation. Pembrolizumab/vibostolimab coformulation had a less favorable safety profile and lower antitumor activity than either pembrolizumab or vibostolimab alone.

Anonymous Patient Answer

What are the common side effects of pembrolizumab/vibostolimab coformulation?

The combination of pembrolizumab/vibostolimab shows a broad spectrum of treatment-related side effects, including fatigue, nausea, headache, and fatigue. Patients are encouraged to monitor weight and blood levels of calcium and phosphorus.

Anonymous Patient Answer
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