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Checkpoint Inhibitor

Nivolumab for Prostate Cancer

Phase 2
Waitlist Available
Led By David J. Einstein, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have experienced biochemical recurrence (BCR) plus have minimum PSA values noted below: Following primary RP: Any detectable rising PSA after RP (or after salvage RT if performed), minimum PSA 1.0 at time of screening Following primary RT: PSA rise to ≥2 ng/mL above the nadir No evidence of metastases on conventional imaging (CT or MRI plus bone scan) PSA doubling time (PSADT) <10 months --PSADT: calculated as per Prostate Cancer Working Group 3 (PCWG3) and the Memorial Sloan Kettering Cancer Center calculator: (https://www.mskcc.org/nomograms/prostate/psa_doubling_time) With linear regression model of normal logarithm of PSA and time, based on: At least 3 consecutive PSA values with each value ≥0.2 ng/mL Interval between first and last PSA values is ≥8 weeks but ≤12 months.
PSA doubling time (PSADT) <10 months --PSADT: calculated as per Prostate Cancer Working Group 3 (PCWG3) and the Memorial Sloan Kettering Cancer Center calculator: (https://www.mskcc.org/nomograms/prostate/psa_doubling_time)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether or not the drug is effective in treating prostate cancer.

Who is the study for?
This trial is for men over 18 with high-risk prostate cancer that's come back, shown by rising PSA levels after surgery or radiation. They must have no metastases on scans, a fast PSA doubling time (<10 months), and good organ function. Participants need to understand the study and consent to it, agree to use contraception if necessary, and not be on certain other treatments or have serious health issues.Check my eligibility
What is being tested?
The trial is testing Nivolumab, an immune-based cancer drug for treating prostate cancer that has returned biochemically but hasn't spread. It aims to see how well this drug can manage such cases in patients who meet specific criteria regarding their PSA levels and overall health.See study design
What are the potential side effects?
Nivolumab may cause side effects related to the immune system like inflammation of organs, potential autoimmune reactions, fatigue, skin conditions or digestive problems. The severity of these side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My PSA is rising, and I have no cancer spread on scans. My PSA doubles in less than 10 months.
Select...
My PSA levels double in less than 10 months.
Select...
My PSA levels are rising and are above 1.0 after prostate surgery.
Select...
- You must have tissue samples available for testing, either from a prostatectomy or biopsy. - You must consent to genetic testing performed on this tissue. - You must be at least 18 years old and have adequate organ and marrow function. - You must have a certain level of blood counts and normal kidney and liver function. - You must have a testosterone level of at least 100 ng/dL. - You must have recovered from any toxicity related to prior treatment or have no treatment-related toxicity greater than grade 2. - Having a history of other cancer is not a problem as long as it's stable and doesn't require treatment. - You must be able to understand and follow study procedures. - Male patients with female partners of reproductive potential must agree to use contraception during the trial period.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Select...
I had prostate cancer confirmed by biopsy and treated with surgery or radiation.
Select...
I agree to use contraception during the trial if my partner can become pregnant.
Select...
I had prostate cancer confirmed by biopsy and treated with surgery or radiation.
Select...
My biopsy showed cancer in at least 3 tissue samples.
Select...
My kidney function is within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control
Secondary outcome measures
Best PSA response during nivolumab treatment as an absolute change relative to baseline
Change in PSA doubling time (PSADT) at end-of-study relative to baseline
Maximal change in prostate specific antigen (PSA) during nivolumab treatment
+3 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
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%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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

2Treatment groups
Experimental Treatment
Group I: PD-L1 PositiveExperimental Treatment1 Intervention
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Group II: PD-L1 NegativeExperimental Treatment1 Intervention
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
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?

Dana-Farber Cancer InstituteOTHER
1,071 Previous Clinical Trials
340,333 Total Patients Enrolled
76 Trials studying Prostate Cancer
16,084 Patients Enrolled for Prostate Cancer
Beth Israel Deaconess Medical CenterLead Sponsor
835 Previous Clinical Trials
13,006,499 Total Patients Enrolled
23 Trials studying Prostate Cancer
3,723 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,270 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,416 Patients Enrolled for Prostate Cancer

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03637543 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03637543 — Phase 2

Frequently Asked Questions

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

What is the extent of Nivolumab's research history?

"Nivolumab was first studied a decade ago, in 2010, at the H. Lee Moffitt Cancer Center and Research Institute. So far, there have been 249 completed trials with 747 more still underway. A large concentration of these active clinical trials are based in South Weymouth, New hampshire."

Answered by AI

How many willing test subjects are there for this experiment?

"That is accurate. The clinicaltrials.gov website contains information revealing that this study is currently looking for 34 patients at 5 sites. This trial was originally posted on 10/18/2018 and was most recently edited on 5/16/2022."

Answered by AI

Are people with the qualifying condition still able to join this research project?

"That is correct, the online clinicaltrials.gov registry currently lists this study as open and recruiting new patients. This trial was first posted on October 18th, 2018 and was last updated more recently on May 16th, 2022. A total of 34 individuals are needed for this research project taking place at 5 different hospitals or clinics."

Answered by AI

Have other research groups looked into this intervention before?

"Nivolumab is being studied in 747 active clinical trials, which began as early as 2010. The first study, sponsored by Medarex, completed Phase 1 drug approval with 127 patients. In the 10 years since then, 249 more trials have been conducted."

Answered by AI

What is Nivolumab's typical therapeutic application?

"Nivolumab has applications in the treatment of both cancerous and non-cancerous neoplasms. For example, it can be used to treat metastatic melanoma, squamous cell carcinoma, and unresectable esophageal adenocarcinoma."

Answered by AI

What is the Nivolumab FDA approval status?

"Nivolumab is a Phase 2 medication, meaning that while there is some evidence confirming its safety, none exists to show that it is an effective treatment."

Answered by AI
~5 spots leftby Mar 2025