CLINICAL TRIAL

Nivolumab for Various Advanced Cancer

High Risk
Waitlist Available · 18+ · All Sexes · Mineola, NY

This study is evaluating whether a drug called Nivolumab can help people who have had surgery for bladder cancer.

See full description

About the trial for Various Advanced Cancer

Treatment Groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nivolumab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Side Effect Profile for DOCETAXEL

DOCETAXEL
Show all side effects
40%
Fatigue
32%
Neutropenia
29%
Anaemia
29%
Dyspnoea
27%
Decreased appetite
26%
Diarrhoea
25%
Nausea
22%
Alopecia
21%
Asthenia
19%
Cough
19%
Pyrexia
15%
Constipation
13%
Vomiting
12%
Neuropathy peripheral
12%
Myalgia
12%
Arthralgia
12%
Oedema peripheral
10%
Febrile neutropenia
10%
Mucosal inflammation
9%
Back pain
9%
Chest pain
9%
Dizziness
9%
Rash
8%
Hyperglycaemia
8%
Pneumonia
7%
Abdominal pain
7%
Malignant neoplasm progression
7%
Leukopenia
7%
Headache
7%
Haemoptysis
6%
White blood cell count decreased
6%
Neutrophil count decreased
6%
Paraesthesia
5%
Bone pain
5%
Musculoskeletal pain
5%
Insomnia
5%
Weight decreased
3%
Hypomagnesaemia
3%
Upper respiratory tract infection
3%
Bronchitis
2%
Musculoskeletal chest pain
2%
Infection
2%
Respiratory failure
2%
Atrial fibrillation
2%
Pruritus
2%
Sepsis
2%
Dehydration
2%
Cerebrovascular accident
2%
Pulmonary haemorrhage
2%
Lung infection
2%
Pulmonary embolism
1%
Pleural effusion
1%
Neutropenic infection
1%
Skin infection
1%
Hypoglycaemia
1%
Clostridium difficile colitis
1%
Tumour pain
1%
Metastases to central nervous system
1%
Cardiac tamponade
1%
Enterocolitis infectious
1%
Intestinal perforation
1%
Mental status changes
1%
Aphasia
1%
Confusional state
1%
Goitre
1%
Superior vena cava syndrome
1%
Septic shock
1%
Bronchopneumonia
1%
Chills
1%
Dysphonia
1%
Pneumothorax
1%
Oropharyngeal pain
1%
Hyponatraemia
1%
Delirium
1%
Arterial haemorrhage
1%
Chronic obstructive pulmonary disease
1%
Cardio-respiratory arrest
1%
Acute respiratory failure
1%
Stridor
1%
Febrile bone marrow aplasia
1%
Calculus ureteric
1%
Interstitial lung disease
1%
VIIth nerve paralysis
1%
Peripheral sensory neuropathy
1%
Pancytopenia
1%
Urinary tract infection
1%
Respiratory tract infection
0%
Dysphagia
0%
Ischaemic stroke
0%
Hypothyroidism
0%
Lower respiratory tract infection
0%
Atrial thrombosis
0%
General physical health deterioration
0%
Spinal cord compression
0%
Sudden death
0%
Hypophosphataemia
0%
Generalised tonic-clonic seizure
0%
Sinus bradycardia
0%
Hypercalcaemia
0%
Pneumonitis
0%
Myasthenic syndrome
0%
Peripheral ischaemia
0%
Pulmonary thrombosis
0%
Convulsion
0%
C-reactive protein increased
0%
Tubulointerstitial nephritis
0%
Lobar pneumonia
Fatigue
40%
Neutropenia
32%
Anaemia
29%
Dyspnoea
29%
Decreased appetite
27%
Diarrhoea
26%
Nausea
25%
Alopecia
22%
Asthenia
21%
Cough
19%
Pyrexia
19%
Constipation
15%
Vomiting
13%
Neuropathy peripheral
12%
Myalgia
12%
Arthralgia
12%
Oedema peripheral
12%
Febrile neutropenia
10%
Mucosal inflammation
10%
Back pain
9%
Chest pain
9%
Dizziness
9%
Rash
9%
Hyperglycaemia
8%
Pneumonia
8%
Abdominal pain
7%
Malignant neoplasm progression
7%
Leukopenia
7%
Headache
7%
Haemoptysis
7%
White blood cell count decreased
6%
Neutrophil count decreased
6%
Paraesthesia
6%
Bone pain
5%
Musculoskeletal pain
5%
Insomnia
5%
Weight decreased
5%
Hypomagnesaemia
3%
Upper respiratory tract infection
3%
Bronchitis
3%
Musculoskeletal chest pain
2%
Infection
2%
Respiratory failure
2%
Atrial fibrillation
2%
Pruritus
2%
Sepsis
2%
Dehydration
2%
Cerebrovascular accident
2%
Pulmonary haemorrhage
2%
Lung infection
2%
Pulmonary embolism
2%
Pleural effusion
1%
Neutropenic infection
1%
Skin infection
1%
Hypoglycaemia
1%
Clostridium difficile colitis
1%
Tumour pain
1%
Metastases to central nervous system
1%
Cardiac tamponade
1%
Enterocolitis infectious
1%
Intestinal perforation
1%
Mental status changes
1%
Aphasia
1%
Confusional state
1%
Goitre
1%
Superior vena cava syndrome
1%
Septic shock
1%
Bronchopneumonia
1%
Chills
1%
Dysphonia
1%
Pneumothorax
1%
Oropharyngeal pain
1%
Hyponatraemia
1%
Delirium
1%
Arterial haemorrhage
1%
Chronic obstructive pulmonary disease
1%
Cardio-respiratory arrest
1%
Acute respiratory failure
1%
Stridor
1%
Febrile bone marrow aplasia
1%
Calculus ureteric
1%
Interstitial lung disease
1%
VIIth nerve paralysis
1%
Peripheral sensory neuropathy
1%
Pancytopenia
1%
Urinary tract infection
1%
Respiratory tract infection
1%
Dysphagia
0%
Ischaemic stroke
0%
Hypothyroidism
0%
Lower respiratory tract infection
0%
Atrial thrombosis
0%
General physical health deterioration
0%
Spinal cord compression
0%
Sudden death
0%
Hypophosphataemia
0%
Generalised tonic-clonic seizure
0%
Sinus bradycardia
0%
Hypercalcaemia
0%
Pneumonitis
0%
Myasthenic syndrome
0%
Peripheral ischaemia
0%
Pulmonary thrombosis
0%
Convulsion
0%
C-reactive protein increased
0%
Tubulointerstitial nephritis
0%
Lobar pneumonia
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01642004) in the DOCETAXEL ARM group. Side effects include: Fatigue with 40%, Neutropenia with 32%, Anaemia with 29%, Dyspnoea with 29%, Decreased appetite with 27%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients who have not received prior neoadjuvant cisplatin chemotherapy and who do not want to receive cisplatin-based adjuvant chemotherapy are ineligible for this treatment. show original
or call 1-888-815-4572 You can find information about participating in clinical trials for BMS drugs on the website www.BMSStudyConnect.com or by calling 1-888-815-4572. show original
The person had to have invasive cancer that is likely to come back, originating in the bladder, ureter, or renal pelvis. show original
In order to be eligible for the study, the participant must have had a radical surgery such as a radical cystectomy within the last 120 days. show original
The patient must not have any diseases that are detectable by imaging within 4 weeks of receiving the medication. show original
The tissue that will be used for biomarker analysis must be provided. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Approximately 5 years after the first subject is randomized
Screening: ~3 weeks
Treatment: Varies
Reporting: Approximately 5 years after the first subject is randomized
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Approximately 5 years after the first subject is randomized.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nivolumab will improve 3 primary outcomes and 9 secondary outcomes in patients with Various Advanced Cancer. Measurement will happen over the course of on going.

Overall Survival
ON GOING
the time from randomization to the date of death from any cause.
ON GOING
Overall Survival in Participants With PD-L1 Expression ≥ 1%
ON GOING
the time from randomization to the date of death from any cause.
ON GOING
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
ON GOING
the time from randomization to the date of death due to disease (urothelial cancer).
ON GOING
Disease Specific Survival
ON GOING
the time from randomization to the date of death due to disease (urothelial cancer).
ON GOING
Disease Free Survival (DFS)
APPROXIMATELY UP TO 48 MONTHS
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
APPROXIMATELY UP TO 48 MONTHS
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
APPROXIMATELY UP TO 48 MONTHS
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
APPROXIMATELY UP TO 48 MONTHS
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Patient Q & A Section

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

What are the signs of various advanced cancer?

The [signs of various advanced cancer are not the same in every cancer. To find these signs, search for them through the Cancer.gov or [Oncozoom.com] (http://www.oncozymolife.com/treatments/signs_cancer) databases.

Anonymous Patient Answer

Can various advanced cancer be cured?

These trials reveal that cure or prolonged benefit as a possible treatment of varying advanced cancers is not always achievable. Recent findings also show that for some of these treatments, the risks of treatment may be great.

Anonymous Patient Answer

What are common treatments for various advanced cancer?

There is substantial variation in most treatments across advanced cancer, including palliative care. Most patients were not given any form of palliative care. It is important for palliative and oncologist to inform patients on treatment, as it can alleviate the physical burdens.

Anonymous Patient Answer

What is various advanced cancer?

The term “cancer” is used throughout the literature for all advanced cancers. Although there are many forms of cancer, in general, they share similar qualities such as malignant growth, rapid growth, invasion, metastasis, high resistance, and death from a cancer within 6–8 month. All of them should be treated in a similar manner.

Anonymous Patient Answer

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

There were 815,000 people with various advanced cancer in 2009 in the United States. Based on the assumptions that the true incidence of a specific cancer was 20% in the general population and that 0.

Anonymous Patient Answer

What causes various advanced cancer?

This is one of the few cohorts with known causes of advanced cancer. The vast majority of advanced cancers have a multiomarceral aetiology. There are some unique aetiologies of particular cancers discussed here. Further prospective research into these issues is required to elucidate the mechanisms.

Anonymous Patient Answer

What is the primary cause of various advanced cancer?

The overall results were not very different from other studies in developed countries. Findings from a recent study adds the new information that [breast and [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer)s were more likely to be caused by genetic factors] compared to other studies. In the primary cause [cancers] of the advanced cancers which affect more than 50% of the patients, we could not find the information so far.

Anonymous Patient Answer

What is the average age someone gets various advanced cancer?

Age, gender, ethnicity, marital status, and the presence of a cancer screening test all have significant, complementary associations with various cancers. The distribution of age at diagnosis varied significantly by cancer type and the average age for each type differs by gender and ethnicity, reflecting differing ages at cancer onset. The highest mean ages for cancer with the greatest number of diagnoses were seen for various leukemias/lymphomas, melanoma, brain tumors, and renal cell carcinomas; the lowest mean ages for cancers with the greatest number of diagnoses were seen for lung cancer, pancreatic cancer, testicular cancer, and colorectal cancer. Results from a recent clinical trial is the first to describe the age distribution of all patients in a cohort of different cancers.

Anonymous Patient Answer

What is the latest research for various advanced cancer?

There are many types of advanced cancer, and for many people, cancer therapy is not curative or is not tolerated by the patients. The current research on advanced cancer and the people affected is in its infancy, and there is still work and understanding needed. You can help by viewing the latest research at [Cancer Research UK(CRUK) Cancer Research UK's website.]\n

Anonymous Patient Answer

What are the common side effects of nivolumab?

Although the most common treatment related adverse events are often mild, they necessitate discontinuation for some. The drug should not be prescribed to patients with comorbidities associated with severe toxicity.

Anonymous Patient Answer

What is nivolumab?

While nivolumab has been given the nickname of "-mono" for its ability to treat only one cancer, it is one of a new generation of anti-interleukin-4 antibody (or immunotherapy) drugs that have the ability to treat many diseases. It is approved for patients with metastatic melanoma and metastatic non-small cell lung cancer.\nNivolumab received FDA approval for use in the United States on April 14, 2016 in the treatment of squamous non-small cell lung cancer (NSCLC) with EGFR or ALK mutation positive. Additional clinical trials need to show nivolumab is effective in other cancers.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Various Advanced Cancer by sharing your contact details with the study coordinator.