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PD-1 Inhibitor
Nivolumab for Recurrent Prostate Cancer
Phase 2
Recruiting
Led By Mark Markowski, MD/PhD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inactivating mutation (at least monoallelic of CDK12 by clinical grade testing
Must have at least one of the following genetic alterations identified using archival tissue (i.e. prostate needle biopsy prior to radiation therapy or prostatectomy specimen):
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post-intervention
Awards & highlights
Study Summary
This trial found that in men with prostate cancer that had come back after treatment, those whose tumors had a specific biomarker were more likely to respond to the immunotherapy drug nivolumab than to hormone therapy.
Who is the study for?
This trial is for men over 18 with biochemically recurrent prostate cancer that's MMR-deficient, indicated by specific genetic markers. They must have a PSA level >=1.0 ng/mL and normal organ/bone marrow function. Prior local therapy is required but no recent metastatic disease or ADT treatment in the past 6 months. Participants need a life expectancy of at least 6 months and agree to contraception use.Check my eligibility
What is being tested?
The trial tests Nivolumab, an immune checkpoint inhibitor, as a non-hormonal treatment option for prostate cancer patients with certain biomarkers (dMMR, MSI-H, high TMB). It offers an alternative to standard care like surveillance or hormone therapy which lacks survival benefits in this stage.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation of organs, potential liver toxicity, fatigue, skin reactions and can increase the risk of infections due to its action on the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a specific genetic change in the CDK12 gene.
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My cancer has at least one genetic change identified in previous tissue samples.
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My hemoglobin level is at least 9.0 g/dL and I haven't had a blood transfusion in the last 28 days.
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I haven't had any cancer except skin cancer in the last 5 years.
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My cancer is MSI-high.
Select...
My cancer has a specific genetic mutation in MSH2, MSH6, MLH1, or PMS2.
Select...
My tumor has a high number of mutations.
Select...
I have had surgery or radiation therapy for prostate cancer.
Select...
My cancer lacks certain proteins according to a special test.
Select...
I am a man aged 18 or older.
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I am mostly able to care for myself and carry out daily activities.
Select...
My recent scans show no signs of cancer spread.
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I am a male willing to use two effective birth control methods during and 7 months after treatment.
Select...
My kidneys work well enough, with a creatinine clearance of 40 mL/min or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with PSA50 response
Secondary outcome measures
Metastasis-free survival
Number of participants who achieve undetectable PSA
PSA progression-free survival (PSA-PFS)
+2 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab in biochemically recurrent prostate cancerExperimental Treatment1 Intervention
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,905 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,333 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,449 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,432 Patients Enrolled for Prostate Cancer
Mark Markowski, MD/PhDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had radiation therapy over 6 months ago, if at all.I have cancer that has spread or I have another active cancer.I haven't had hormone therapy for cancer in the last 6 months and my testosterone is above 150 ng/dL.I do not have HIV or AIDS.I do not have any major infections that are not under control.My heart condition severely limits my daily activities.You have had a serious allergic reaction to any type of antibody medication.My cancer has a specific genetic change in the CDK12 gene.My cancer has at least one genetic change identified in previous tissue samples.I haven't taken certain prostate cancer drugs in the last 2 weeks, but stable on finasteride or dutasteride for 6 months.My hemoglobin level is at least 9.0 g/dL and I haven't had a blood transfusion in the last 28 days.I haven't had any cancer except skin cancer in the last 5 years.I am only using corticosteroids for specific, non-systemic reasons.My cancer is MSI-high.My cancer has a specific genetic mutation in MSH2, MSH6, MLH1, or PMS2.My tumor has a high number of mutations.I do not have any severe, uncontrolled health issues that could make treatment risky.I have had surgery or radiation therapy for prostate cancer.My kidneys are functioning well enough for treatment.My bone marrow is not forming cells properly.My cancer lacks certain proteins according to a special test.I have not received any treatments targeting immune checkpoints.I am a man aged 18 or older.You have a serious health condition that, according to the doctor, would make participating in this study too risky.I am mostly able to care for myself and carry out daily activities.You have had an allergic reaction to any of the ingredients in the study drug in the past.My recent scans show no signs of cancer spread.I am cautious with medications that can harm the liver while on nivolumab.I am not on high-dose steroids or other immune-weakening drugs.I am a male willing to use two effective birth control methods during and 7 months after treatment.I do not have an active autoimmune disease except for allowed conditions like vitiligo or type I diabetes.My organ and bone marrow functions are normal as tested within the last 28 days.My kidneys work well enough, with a creatinine clearance of 40 mL/min or more.I cannot control my bowel movements.You are allergic to any of the substances being studied.I have Crohn's disease or ulcerative colitis.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab in biochemically recurrent prostate cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has a similar undertaking been attempted in the past?
"Nivolumab is the focus of 717 ongoing investigations across 2356 cities and 49 nations. Ono Pharmaceutical Co. Ltd initiated its initial study back in 2012, which was composed of 659 patients and proceeded through Phase 1 & 2 drug approval stages. Since then, 252 trials have been completed for Nivolumab."
Answered by AI
Are there any prior studies that have employed Nivolumab?
"Currently, there are 717 clinical trials related to Nivolumab; 82 of them being in Phase 3. These studies span across 40281 locations around the world, with a majority concentrated near Bern, BE."
Answered by AI
Has Nivolumab received authorization from the FDA?
"According to our team's assessment, Nivolumab achieved a score of two as it is in its second phase of clinical trials; while there are some indications that the drug is safe, there has not yet been sufficient data on efficacy."
Answered by AI
What application is Nivolumab typically employed for?
"Nivolumab is often employed to treat malignant neoplasms, though it can also assist those afflicted with conditions such as metastatic esophageal adenocarcinoma, squamous cell carcinoma and unresectable melanoma."
Answered by AI
How many enrollees have been included in this clinical experiment?
"Indeed, the clinical trial page on clinicaltrials.gov reports that this study is currently enrolling patients. It was initially listed on January 13th 2020 and most recently updated April 15th 2022. The research team requires 15 volunteers to be recruited from one medical centre."
Answered by AI
Is this research endeavor currently recruiting individuals for participation?
"Affirmative. According to the information posted on clinicaltrials.gov, this trial is actively seeking participants and has been since it was initially published on January 13th 2020. The last update occurred on April 15th 2022, and the study requires 15 individuals from a single location for enrollment."
Answered by AI
Recent research and studies
CellJournal
Inactivation of CDK12 Delineates a Distinct Immunogenic Class of Advanced Prostate CancerOther Trials to Consider
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