Nivolumab for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD
Prostate Cancer+3 More
Nivolumab - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

Nivolumab in Biochemically Recurrent dMMR Prostate Cancer

See full description

Eligible Conditions

  • Prostate Cancer
  • Prostate Cancer - Recurrent

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Nivolumab will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of up to 100 days post-intervention.

Day 100
Safety and tolerability of Nivolumab in biochemically recurrent prostate cancer as assessed by Incidence of Treatment-Emergent Adverse Events
Month 6
Metastasis-free survival
Number of participants who achieve undetectable PSA
PSA progression-free survival (PSA-PFS)
Percentage of participants with PSA50 response
Time to initiation of next systemic therapy

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

NIVOLUMAB 3 mg/kg
Fatigue
38%
Nausea
29%
Decreased appetite
28%
Cough
25%
Diarrhoea
25%
Dyspnoea
24%
Vomiting
20%
Constipation
19%
Anaemia
14%
Weight decreased
14%
Malignant neoplasm progression
13%
Arthralgia
13%
Pruritus
13%
Aspartate aminotransferase increased
13%
Back pain
13%
Pyrexia
12%
Rash
12%
Oedema peripheral
11%
Myalgia
10%
Productive cough
10%
Abdominal pain
10%
Dizziness
10%
Headache
9%
Non-cardiac chest pain
9%
Hypoalbuminaemia
9%
Alanine aminotransferase increased
9%
Hyponatraemia
9%
Asthenia
8%
Hypokalaemia
7%
Hypothyroidism
7%
Upper respiratory tract infection
7%
Musculoskeletal pain
7%
Hyperglycaemia
6%
Musculoskeletal chest pain
6%
Blood alkaline phosphatase increased
6%
Nasopharyngitis
6%
Pain in extremity
6%
Insomnia
6%
Haemoptysis
6%
Dry skin
6%
Dyspepsia
6%
Chills
6%
Lymphocyte count decreased
6%
Dysgeusia
5%
Hypomagnesaemia
5%
Rash maculo-papular
5%
Pneumonia
4%
Blood creatinine increased
4%
Muscular weakness
4%
Hypophosphataemia
3%
Stomatitis
3%
Chest pain
3%
Dysphonia
3%
Pneumonitis
3%
Mucosal inflammation
2%
Pulmonary embolism
2%
Peripheral sensory neuropathy
2%
Alopecia
2%
Pleural effusion
2%
Lung infection
2%
Pericardial effusion malignant
2%
Epistaxis
2%
Adrenal insufficiency
1%
Cancer pain
1%
Confusional state
1%
Pathological fracture
1%
Dehydration
1%
Respiratory failure
1%
Neutrophil count decreased
1%
Acute coronary syndrome
1%
Hypercalcaemia
1%
Chronic obstructive pulmonary disease
1%
Thrombocytopenia
1%
Syncope
1%
Neutropenia
1%
Infusion related reaction
1%
Pneumothorax
1%
Pulmonary haemorrhage
1%
Deep vein thrombosis
1%
Lacrimation increased
1%
Colitis
1%
General physical health deterioration
1%
Cholecystitis acute
1%
Hypersensitivity
1%
Sepsis
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Urinary tract infection
1%
Gamma-glutamyltransferase increased
1%
Metastases to central nervous system
1%
Lung neoplasm malignant
1%
Malignant pleural effusion
1%
Metastases to spine
1%
Tumour pain
1%
Cerebrovascular accident
1%
Seizure
1%
Renal failure
1%
Platelet count decreased
1%
White blood cell count decreased
1%
Diverticulitis
0%
Cholestasis
0%
Kyphosis postoperative
0%
Haemangioblastoma
0%
Aphasia
0%
Vascular occlusion
0%
Circulatory collapse
0%
Oesophagitis
0%
Metastases to meninges
0%
Epilepsy
0%
Haematuria
0%
Leukopenia
0%
Cataract
0%
Myocardial ischaemia
0%
Hepatic failure
0%
Influenza
0%
Spinal cord compression
0%
Pulmonary microemboli
0%
Embolism
0%
Iliac artery occlusion
0%
Death
0%
Bronchitis
0%
Localised infection
0%
C-reactive protein increased
0%
Haemoglobin decreased
0%
Presyncope
0%
Polyarthritis
0%
Mental status changes
0%
Bronchial obstruction
0%
Lumbar vertebral fracture
0%
Sinus bradycardia
0%
Radiation pneumonitis
0%
Hypoglycaemia
0%
Muscle spasticity
0%
Vocal cord paralysis
0%
Pulmonary oedema
0%
Suicide attempt
0%
Rash papular
0%
Cellulitis
0%
Haemothorax
0%
Mediastinal disorder
0%
Small intestinal obstruction
0%
Catheter site pain
0%
Appendicitis perforated
0%
Hepatitis
0%
Acute respiratory failure
0%
Pneumonia aspiration
0%
Aortic aneurysm rupture
0%
Vein disorder
0%
Upper gastrointestinal haemorrhage
0%
Osteolysis
0%
Pancytopenia
0%
Febrile neutropenia
0%
Atrial flutter
0%
Atrial fibrillation
0%
Acute left ventricular failure
0%
Cardiac arrest
0%
Cardiac failure
0%
Cardiac failure acute
0%
Cardiac failure congestive
0%
Myocardial infarction
0%
Cardiac tamponade
0%
Pericardial effusion
0%
Gastrointestinal haemorrhage
0%
Dysphagia
0%
Ileus
0%
Large intestinal obstruction
0%
Multiple organ dysfunction syndrome
0%
Performance status decreased
0%
Pain
0%
Appendicitis
0%
Erysipelas
0%
Peritonitis
0%
Respiratory tract infection
0%
Pneumonia bacterial
0%
Septic shock
0%
Skin infection
0%
Subcutaneous abscess
0%
Femur fracture
0%
Procedural complication
0%
Radiation necrosis
0%
Blood bilirubin increased
0%
Upper limb fracture
0%
Transaminases increased
0%
Bone pain
0%
Malignant melanoma
0%
Malignant neoplasm of spinal cord
0%
Non-small cell lung cancer
0%
Ataxia
0%
Depressed level of consciousness
0%
Loss of consciousness
0%
Psychotic disorder
0%
Atelectasis
0%
Eosinophilic pneumonia
0%
Pleuritic pain
0%
Superior vena cava syndrome
0%
Hypotension
0%
Jugular vein thrombosis
0%
Stevens-johnson syndrome
0%
Air embolism
0%
Peripheral artery thrombosis
0%
Fall
0%
Interstitial lung disease
0%
Acute kidney injury
0%
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

1 Treatment Group

Nivolumab in biochemically recurrent prostate cancer
1 of 1
Experimental Treatment

This trial requires 15 total participants across 1 different treatment group

This trial involves a single treatment. Nivolumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Nivolumab in biochemically recurrent prostate cancer
Drug
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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months post-intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months post-intervention for reporting.

Closest Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, MD

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostate Cancer or one of the other 3 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:
Willing and able to provide signed informed consent and HIPAA authorization for the release of personal health information
Males aged 18 years and above
Prior local therapy with prostatectomy or EBRT/brachytherapy is required
Prior salvage or adjuvant radiation therapy is allowed but not mandated. Radiation therapy must have been completed for at least 6 months.
Absolute PSA >=1.0 ng/mL at screening
Microsatellite instability (MSI-high) status by clinical grade testing
MMR protein loss (MSH2, MSH6, MLH1, PMS2) by immunohistochemistry
Inactivating mutation of MSH2, MSH6, MLH1 or PSM2 by clinical grade genomic testing
Tumor mutational burden >= 20 mutations/megabase (TMB >=20 muts/Mb) by clinical grade testing
Inactivating mutation (at least monoallelic of CDK12 by clinical grade testing

Patient Q&A Section

What are the signs of prostate cancer?

"Findings from a recent study suggest that the majority of prostate cancer patients at diagnosis have symptoms. Thus, further investigation into the utility of symptom questionnaires and tools for self-screening is warranted. The high level of symptom interference was notable." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"We have reviewed the literature on therapies used to treat prostate cancer in developing countries in Africa, Asia, Central and South America, and the Caribbean. Although most studies were small and retrospective, our findings are consistent with the literature on developed countries as a whole; that is, patients typically receive aggressive treatments regardless of stage or comorbidity." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"In men aged 45 to 75 years, prostate cancer has a significant impact on HR-QOL. A comprehensive assessment of the physical as well as the psychosocial features of prostate cancer in young men should be initiated for the purpose of assessing HR-QOL in prostate cancer and developing intervention programs to prevent negative patient outcomes." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"answer: The data point to the environmental factors, with possible contributions of lifestyle and diet, as a probable trigger for prostate cancers in the western populations." - Anonymous Online Contributor

Unverified Answer

How many people get prostate cancer a year in the United States?

"Nearly one-fourth (23%) of American men have some symptoms of BPH at any given point in time. Most symptomatic men have no symptoms or other health problems and can be reassured that most symptoms in this cohort are nonsignificant. Over 2% of men in the United States will eventually be diagnosed with prostate cancer." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"Data from a recent study suggest that, although radical treatment may help cure stage 2-4 and high-risk localized PC, its benefit does not extend to low-risk disease or the most indolent stages of disease." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nivolumab for therapeutic use?

"nivolumab is a therapeutic agent which can have a significant impact on the treatment of patients with cancer, especially in metastatic cancer which is currently difficult to treat. Nivolumab has shown to be useful for advanced NSCLC and for metastatic melanoma, and it has been used for some patients with metastatic sarcoma and for early-stage melanoma, including unresectable stage 2 and stage 1B melanomas. However, caution is stressed because of the risk of neurotoxicity." - Anonymous Online Contributor

Unverified Answer

How serious can prostate cancer be?

"The prognosis of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is determined by factors such as the extent of disease and other underlying conditions. Age, race and cancer stage, in particular, remain the most important prognostic factors. Although a high preoperative PSA level, a Gleason score of eight or higher, and clinical stage, can all signify adverse prognosis, cancer stage is still the most important factor, providing an indication of how often the cancer will recur." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating prostate cancer?

"Most recently, however, the role of androgen deprivation has been questioned. We hypothesize that the use of medications that inhibit androgen signaling in prostate cancer might reduce their androgen-insensitivity syndromes. The development of novel androgen-signaling-inhibiting agents must be encouraged." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostate cancer?

"The rate of diagnosed PCa is increasing in Japan. The average age when PCa is diagnosed has remained stable or decreased across a decade. The PCa treatment was not related to other medical expenses except for hospitalizations. Findings from a recent study has a limitation in that it was based on data from a single institution with a low sample size." - Anonymous Online Contributor

Unverified Answer

What does nivolumab usually treat?

"The most commonly reported adverse effects were fatigue, cough, nausea, constipation, and vomiting and were of mild to moderate intensity, while the most frequent effect in more than 10% of patients were constipation affecting up to 14% of patients. No other serious adverse events were reported. The overall and the most common (≥10% of patients) adverse events were considered manageable in most (84%) and were in line with known TNFα antibody therapeutics. Based on these findings, nivolumab is considered safe, but other effects of the drug (e.g. lung injury, interstitial pneumonitis) should be reported immediately. In general, the tolerability profile was similar to that of infliximab." - Anonymous Online Contributor

Unverified Answer

What is nivolumab?

"Clinical presentation was similar to that of ipilimumab. Nivolumab, at a higher dose, resulted in a significantly longer PFS and OS in this exploratory analysis of nivolumab monotherapy in patients with metastatic breast cancer with good performance status and ≥1 prior line of therapy. Results from a recent paper suggest that nivolumab may have potential clinical utility as a monotherapy in patients with metastatic breast cancer." - 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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