Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Vidutolimod + Nivolumab for Prostate Cancer
Phase 2
Recruiting
Led By Mehmet A Bilen, M.D.
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects refractory to a novel antiandrogen therapy and failed at least 1 taxane based chemotherapy regimen
Willingness to provide pre- and post-treatment fresh tumor biopsies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
Study Summary
This trial is testing whether a combination of two drugs, vidutolimod and nivolumab, can better treat patients with prostate cancer that has spread to other parts of the body by stimulating the immune system to more effectively kill cancer cells.
Who is the study for?
Men over 18 with advanced prostate cancer resistant to certain therapies and chemotherapy, or those unsuitable for such treatments. Participants must have stable vital functions, no severe bleeding risks, measurable disease amenable to injection, and be willing to provide biopsies. They should not have other active cancers or serious illnesses that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing vidutolimod combined with nivolumab in men whose prostate cancer has spread despite treatment. Vidutolimod activates immune cells while nivolumab blocks a protein that turns off the immune response, potentially allowing the body to better fight cancer.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms from vidutolimod (fever, chills), and typical immunotherapy-related issues like fatigue, skin rash or inflammation of organs due to nivolumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have cancer that didn't respond to a new hormone therapy and one chemotherapy.
Select...
I am willing to provide tissue samples before and after treatment.
Select...
My prostate cancer has spread to other parts of my body.
Select...
I have had an orchiectomy or my testosterone levels are below 50 ng/dL.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
I am a man who is either surgically sterile or will use contraception.
Select...
My blood clotting tests are normal or near normal, unless I'm on blood thinners.
Select...
I am a man aged 18 or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of Treatment
Secondary outcome measures
ORR
Objective response rate (ORR)
Overall survival (OS)
+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: Treatment ((vidutolimod, nivolumab)Experimental Treatment2 Interventions
Patients receive vidutolimod SC on days 1 and 7 of cycle 1, IT on day 14 of cycle 1 and days 1 and 14 of cycle 2, and then SC on day 1 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 14 of cycle 2 and on day 1 of subsequent cycles. Cycles of nivolumab repeat every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cycles of vidutolimod repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,770 Total Patients Enrolled
28 Trials studying Prostate Cancer
1,930 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,844 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,686 Total Patients Enrolled
17 Trials studying Prostate Cancer
7,157 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that didn't respond to a new hormone therapy and one chemotherapy.I am willing to provide tissue samples before and after treatment.All my side effects from previous cancer treatments are mild.I stopped taking anti-PD1/PDL1 due to a severe side effect.I am currently on medication for an infection.My prostate cancer is not adenocarcinoma but a different type.I have not had a live virus vaccine in the last 30 days.I have not had severe heart problems in the last 6 months.I haven't had cancer treatment in the last 14 days.I have untreated brain metastases that are causing symptoms or getting bigger.My prostate cancer has spread to other parts of my body.I have had an orchiectomy or my testosterone levels are below 50 ng/dL.My kidney function, measured by creatinine levels, is within the normal range.I have had a transplant of tissue or an organ from another person.I am a man who is either surgically sterile or will use contraception.I have another cancer that is getting worse or needed treatment in the last 3 years.I have had pneumonitis treated with steroids or have it now.I have been treated with CMP-001 or anti-PD1/PDL1 before.My blood clotting tests are normal or near normal, unless I'm on blood thinners.I finished my last cancer treatment at least 2 weeks ago.I have taken more than 10 mg/day of prednisone or similar medication in the last week.I am a man aged 18 or older.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with HIV, hepatitis B, or hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment ((vidutolimod, nivolumab)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Are there any unfilled slots in this clinical trial that patients can apply for?
"The study recently hosted on clinicaltrials.gov is no longer recruiting patients, as it was initially posted on November 30th 2022 and the most recent update occurred in August 26th 20202. However, there are still 1252 other studies that are actively enrolling participants at this time."
Answered by AI
Are there any threats posed by Nivolumab to human health?
"A score of 2 was assigned to Nivolumab's safety, as prior clinical data indicates that it is likely safe - but no efficacy information has been gathered yet."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger