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Monoclonal Antibodies
Cohort B for Prostate Cancer
Phase 2
Recruiting
Led By Matthew Dallos, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
"This trial aims to test whether adding 2141-V11 to standard prostate cancer treatments is effective. 2141-V11 activates the immune system to target and destroy cancer cells. Researchers will assess if
Who is the study for?
Men over 18 with prostate cancer who have not had certain treatments or surgeries for it. They must be able to consent, have a targetable lesion on MRI, and agree to use contraception if sexually active. Excluded are those with recent experimental therapy, significant heart disease, inability to undergo MRI, known metastases in specific organs, inflammatory bowel disease, HIV under certain conditions, seizure risks, severe allergies or liver impairment.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a new antibody called 2141-V11 when combined with standard prostate cancer treatments. It aims to activate the immune system against cancer cells and will measure success by checking for minimal residual disease – tiny amounts of cancer that might remain after treatment.See study design
What are the potential side effects?
While specific side effects of 2141-V11 aren't listed here, similar immune-activating antibodies can cause reactions like flu-like symptoms (fever/chills), fatigue, allergic responses at infusion sites and potentially affect organ function due to an overactive immune response.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with a complete response or minimal residual disease.
Side effects data
From 2021 Phase 2 trial • 22 Patients • NCT03019640100%
Nausea
100%
White blood cell decreased
100%
Lymphocyte count decreased
100%
Fever
100%
Platelet count decreased
100%
Anemia
100%
Neutrophil count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Hypotension
59%
Anorexia
55%
Hypophosphatemia
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
50%
Headache
45%
Hypoalbuminemia
45%
Hypocalcemia
45%
Alanine aminotransferase increased
41%
Hypokalemia
41%
Dizziness
36%
Hyponatremia
36%
Anxiety
32%
Investigations
32%
Insomnia
32%
Vomiting
32%
Chills
32%
Cough
32%
Febrile neutropenia
32%
Hypertension
27%
Pain
27%
Alkaline phosphatase increased
27%
Aspartate aminotransferase increased
23%
Infections and infestations
23%
Hypomagnesemia
23%
Dysphagia
23%
Arthralgia
23%
Esophagitis
23%
Hiccups
18%
Dehydration
18%
Hypoxia
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hemorrhoids
14%
Infusion related reaction
14%
INR increased
14%
Immune system disorders
14%
Bloating
14%
Paresthesia
14%
Pleural effusion
14%
Dyspepsia
14%
Hypermagnesemia
14%
Rectal pain
9%
Sore throat
9%
Upper respiratory infection
9%
Blood bilirubin increased
9%
Bone pain
9%
Cholesterol high
9%
Creatinine increased
9%
Nasal congestion
9%
Papulopustular rash
9%
Arthritis
9%
Back pain
9%
Dry skin
9%
Dysgeusia
9%
Flushing
9%
General disorders and administration site conditions
9%
Hypernatremia
9%
Hyperuricemia
9%
Non-cardiac chest pain
9%
Renal and urinary disorders
9%
Skin ulceration
5%
Hypoglycemia
5%
Lymph node pain
5%
Tremor
5%
Hypothyroidism
5%
Thromboembolic event
5%
Urinary tract pain
5%
Lymphocyte count increased
5%
Myalgia
5%
Urinary tract infection
5%
Urinary frequency
5%
Lung infection
5%
Weight gain
5%
Vascular disorders
5%
Lung
5%
Eye disorders
5%
Gastroesophageal reflux disease
5%
Mucosal infection
5%
Metabolism and nutrition disorders
5%
Musculoskeletal and connective tissue disorder
5%
Peripheral motor neuropathy
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Rash acneiform
5%
Respiratory failure
5%
Acute kidney injury
5%
Ear pain
5%
Edema face
5%
Encephalopathy
5%
Endocrine disorders
5%
Atelectasis
5%
Atrial fibrillation
5%
Bladder infection
5%
Epistaxis
5%
Flatulence
5%
Gastrointestinal pain
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypercalcemia
5%
Neck pain
5%
Nervous system disorders
5%
Pain in extremity
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Skin hyperpigmentation
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment1 Intervention
Men presenting with low-volume metastatic disease for whom a multimodality therapeutic approach including removal of the primary has the potential to eliminate all disease.
Group II: Cohort BExperimental Treatment1 Intervention
Men presenting with clinically localized or locoregional high-risk disease.
Group III: Cohort AExperimental Treatment1 Intervention
Men presenting with clinically localized intermediate-risk disease for whom surgery can be safely delayed for neoadjuvant treatment.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,799 Total Patients Enrolled
132 Trials studying Prostate Cancer
51,983 Patients Enrolled for Prostate Cancer
Matthew Dallos, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
202 Total Patients Enrolled
3 Trials studying Prostate Cancer
145 Patients Enrolled for Prostate Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the level of risk associated with Cohort A for individuals?
"According to our evaluation at Power, the safety rating for Cohort A is a 2 as per our scale from 1 to 3. This score reflects available safety data without corresponding efficacy evidence due to the trial being in Phase 2."
Answered by AI
Is the enrollment for this medical study currently accepting new participants?
"As documented on clinicaltrials.gov, this medical investigation is actively pursuing eligible participants. The trial was initially listed on March 28th, 2024 and most recently revised on March 29th, 2024."
Answered by AI
Are there multiple locations in North America conducting this clinical trial?
"The trial is currently ongoing at seven sites, such as Memorial Sloan Kettering in Basking Ridge, Middletown, and Montvale."
Answered by AI
What is the upper limit for the total number of participants who can enroll in this clinical trial?
"Indeed, information from clinicaltrials.gov indicates that this research endeavor is actively seeking suitable participants. This trial was initially uploaded on March 28th, 2024 and last revised on March 29th, 2024. The study aims to recruit a total of 99 patients distributed across seven different locations."
Answered by AI
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