Ipilimumab for Metastatic Castration Sensitive Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Metastatic Castration Sensitive Prostate Cancer+2 More
Ipilimumab - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This study is evaluating whether a combination of hormones and immunotherapy can improve survival in men with prostate cancer.

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Eligible Conditions

  • Metastatic Castration Sensitive Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic Castration Sensitive Prostate Cancer

Study Objectives

This trial is evaluating whether Ipilimumab will improve 1 primary outcome and 3 secondary outcomes in patients with Metastatic Castration Sensitive Prostate Cancer. Measurement will happen over the course of at 12 and 20 months.

2 years
Toxicity
overall survival (OS)
progression-free survival (PFS)
Month 20
undetectable PSA

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Metastatic Castration Sensitive Prostate Cancer

Trial Design

2 Treatment Groups

Ipilimumab & Degarelix With Radical Prostatectomy
1 of 2
Ipilimumab & Degarelix With Prior With Radical Prostatectomy
1 of 2
Experimental Treatment

This trial requires 16 total participants across 2 different treatment groups

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

Ipilimumab & Degarelix With Radical ProstatectomyWeek 1: Degarelix SQ injection (except patients who have already received hormonal therapy per standard of care and are not yet due for their next dose) and Ipilimumab at 3 mg/kg intravenously (IV). Surgery Radical prostatectomy (RP)will be performed during week 3 ± 1 week or after recovery to grade ≤ 1 adverse events experienced during the induction period related to treatment. Continued Androgen Depletion and Ipilimumab Weeks 5, 9, 13, 17, 21, 25, and 29: Degarelix 80 mg SQ (except patients who have already received hormonal therapy per standard of care and are not yet due for their next dose) Week 11, 14, 17 or after sufficient wound healing and recovery post RP: Ipilimumab 3 mg/kg IV Follow-up Twelve week intervals until Week 87.
Ipilimumab & Degarelix With Prior With Radical ProstatectomyWeek 1: Degarelix 240 mg SQ injection and Ipilimumab at 3 mg/kg intravenously (IV) Continued Androgen Depletion and Ipilimumab Weeks 5, 9, 13, 17, 21, 25, and 29: Degarelix 80 mg SQ Week 4,7,10: Ipilimumab 3mg/kg IV Follow-up Twelve week intervals until Week 81, with MD visits at weeks 52 and 84 (12 and 20 months).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Degarelix
FDA approved
Ipilimumab
FDA approved
Radical Prostatectomy
2005
Completed Phase 2
~650

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Metastatic Castration Sensitive Prostate Cancer or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Target Population: Cohort A Patients with castration-sensitive oligometastatic prostate cancer who have not received primary local therapy (radiation or surgery), and no more than 5 months of prior androgen deprivation therapy.
The subject must be age 18 or older, and be willing and able to provide informed consent.
The subject must have histologically confirmed adenocarcinoma of the prostate with tissue confirmation at selected study site.
The subject must have newly diagnosed prostate cancer with a metastatic site(s).
The subject must have a history or presence of ≤ 10 bony metastatic lesions
Note: bone mets that are not clearly identified on bone imaging, but are biopsy proven are allowed
History or presence of distant metastatic lymph node(s) (e.g., retroperitoneal or non-regional pelvic lymph nodes) are allowed
History or presence of regional pelvic lymph nodes (as per AJCC Cancer Staging [7th edition]) will be considered a metastatic site if greater than 1.5cm in shortest dimension.
The subject must have Karnofsky performance status of 80-100.
WBC ≥ 2000/μL

Patient Q&A Section

How many people get hypersensitivity a year in the United States?

"The estimated annual incidence of hypersensitivity reaction in US general population ranges from 1.6-4.8/100,000, but the number increases with age. The higher rate in the pediatric population is intriguing and supports the concept of heightened immunologic response to environmental and microbial antigens. The prevalence of the hypersensitivity reaction in the population has yet to be studied in large magnitude, but it may be important in determining the risk of development of asthma and allergic rhinitis." - Anonymous Online Contributor

Unverified Answer

What are the signs of hypersensitivity?

"These include itching, burning, hives, swollen, tender, inflamed and red skin. These can occur from hypersensitivity to foods, insect bites, medications or airborne or contact allergens.\n" - Anonymous Online Contributor

Unverified Answer

What is hypersensitivity?

"Hypersensitivity occurs when the body's allergic response to a harmless substance causes physical symptoms, such as itching, swelling, or blistering (i.e., local and/or generalized reactions) in an allergic body type (i.e., one is allergic to one or more substances). In all types of hypersensitivity, the immune system responds to a very small quantity of a foreign substance (e.g., a viral particle, a foreign bacterium, or an allergen) that otherwise would not be dangerous or detrimental to one's health, but in excess causes an allergic reaction." - Anonymous Online Contributor

Unverified Answer

Can hypersensitivity be cured?

"Hypersensitivity is a rare form of [allergy](https://www.withpower.com/clinical-trials/allergy), and is not easily treated. The most effective treatment is avoidance of the presumed causative agents. For people who cannot or will not avoid their sensitizers, allergen immunotherapy can be a useful treatment." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypersensitivity?

"There is a growing trend of using complementary and alternative medicine (CAM) for many of the common diagnoses, treatments, and conditions that people have to deal with. A growing number use CAM to try to solve their problems. There are many conflicting claims regarding the value of CAM, and only few medical professionals recommend it. There is limited use of CAM for managing anxiety disorders, insomnia, and irritable bowel syndrome." - Anonymous Online Contributor

Unverified Answer

What causes hypersensitivity?

"Most people have been exposed to at least one trigger factor throughout their lives, including: cigarette smoking, chemical inhalants and air pollution. However, these factors do not cause asthma or atopy. At present there is no single cause of these two conditions – just factors affecting the respiratory tract that act together to set off a chain of processes leading to the symptoms of asthma or atopy. There is no clear single cause of persistent cough caused by asthma, and both conditions can be caused by common viral infections.\n" - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hypersensitivity?

"Although the treatment of hypersensitivity remains incompletely understood yet, the current treatment options have been [expanded], and some are used as the first line treatment of choice. There was no significant decrease in the incidence of hypersensitivity reactions over the past 20 years. There have been advances in the understanding of [interferons] and [new drug classes] in treating hypersensitivity reactions." - Anonymous Online Contributor

Unverified Answer

Is ipilimumab safe for people?

"Ipilimumab was well tolerated by the vast majority of patients in the open-label trial. Most patients had adverse events that were manageable; however, adverse events sometimes led to treatment discontinuation. While this study is only a snapshot of a single therapy, the rate and severity of severe adverse events were not surprising. Nevertheless, the benefit of ipilimumab is clear, given its efficacy in controlling disease activity in patients with Crohn's disease." - Anonymous Online Contributor

Unverified Answer

What does ipilimumab usually treat?

"This report shows that ipilimumab can be used to treat a wide range of conditions. Importantly, there are also many conditions for which ipilimumab is frequently used but does not seem to be effective; for these conditions, there are no reported clinical trials. Because no single condition seems to benefit from ipilimumab, our observations provide a starting point for future clinical trials of ipilimumab." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hypersensitivity?

"Based on surveys of over 4000 hypersensitivity subjects, the average age of onset was 21.7 years, with a 90% of cases occurring after the age of 60." - Anonymous Online Contributor

Unverified Answer

How quickly does hypersensitivity spread?

"Most cases of food-related anaphylaxis were due to IgE sensitization to allergens, which quickly spread, with the duration of symptoms following the accidental ingestion ranging from 5 minutes to 72 hours." - Anonymous Online Contributor

Unverified Answer

Is ipilimumab typically used in combination with any other treatments?

"The combined use of ipilimumab with other T-specific agents and targeted agents such as androgen-receptor antagonists, epidermal growth factor receptor inhibitors, chemotherapy regimens, monoclonal antibodies, and immune system inhibitors is common in clinical practice. The use of adjuvant ipilimumab in patients with esophageal cancer following surgery or esophageal cancer-associated peritoneal metastases has also been reported." - Anonymous Online Contributor

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