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Nivolumab Safety for Cancer

Phase 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have completed treatment with nivolumab, progressed on prior nivolumab treatment or discontinued nivolumab due to toxicity in the Parent Study are not eligible to receive nivolumab in this study. These participants may be enrolled for safety and survival follow-up only.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to 135 days after discontinuation of treatment
Awards & highlights

Study Summary

This trial is testing the long-term safety of a cancer drug.

Who is the study for?
This trial is for cancer patients who have previously been treated with Nivolumab, either completed the treatment, experienced progression during it, or stopped due to side effects. They can join for long-term safety follow-up but not receive further Nivolumab unless deemed beneficial by the original study criteria.Check my eligibility
What is being tested?
The main focus of this rollover study is to monitor the long-term safety of Nivolumab in participants who are currently receiving or have received it as part of an earlier 'Parent Study'. It involves observing these patients over time.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones associated with Nivolumab include fatigue, skin issues (like rash), problems with lung function (pneumonitis), and immune-related reactions affecting various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not completed, progressed on, or stopped nivolumab due to side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to 135 days after discontinuation of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to 135 days after discontinuation of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of AEs leading to Discontinuation
Incidence of Adverse Events (AEs)
Incidence of Death
+4 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%
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

32Treatment groups
Experimental Treatment
Group I: E9: Cabozantinib MonotherapyExperimental Treatment1 Intervention
Group II: E8: Capecitabine MonotherapyExperimental Treatment1 Intervention
Group III: E7: Rucaparib MonotherapyExperimental Treatment1 Intervention
Group IV: E6: Sunitinib MonotherapyExperimental Treatment1 Intervention
Group V: E5: Enzalutamide MonotherapyExperimental Treatment1 Intervention
Group VI: E4: Leucovorin + Oxaliplatin + FluorouracilExperimental Treatment3 Interventions
Group VII: E3: Leucovorin + FluorouracilExperimental Treatment1 Intervention
Group VIII: E2: Regorafinib MonotherapyExperimental Treatment1 Intervention
Group IX: E1: Bevacizumab MonotherapyExperimental Treatment1 Intervention
Group X: E11: Pembrolizumab MonotherapyExperimental Treatment1 Intervention
Group XI: E10: Pemetrexed MonotherapyExperimental Treatment1 Intervention
Group XII: D4: Nivolumab + BevacizumabExperimental Treatment1 Intervention
Group XIII: D3: Nivolumab + DaratumumabExperimental Treatment2 Interventions
Group XIV: D2: Nivolumab + RucaparibExperimental Treatment2 Interventions
Group XV: D1: Nivolumab + TemozolomideExperimental Treatment2 Interventions
Group XVI: C9: Relatlimab + Nivolumab SAV + BevacizumabExperimental Treatment3 Interventions
Group XVII: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1Experimental Treatment2 Interventions
Group XVIII: C7: Relatlimab + Nivolumab SAV Dose 3Experimental Treatment2 Interventions
Group XIX: C6: Relatlimab + Nivolumab + CapecitabineExperimental Treatment2 Interventions
Group XX: C5: Relatlimab + Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group XXI: C4: Relatlimab + Nivolumab SAV Dose 2Experimental Treatment2 Interventions
Group XXII: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2Experimental Treatment1 Intervention
Group XXIII: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1Experimental Treatment2 Interventions
Group XXIV: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1Experimental Treatment1 Intervention
Group XXV: C12: Relatlimab + Nivolumab SAV Dose 5Experimental Treatment2 Interventions
Group XXVI: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2Experimental Treatment2 Interventions
Group XXVII: C10: Relatlimab + Nivolumab SAV Dose 4Experimental Treatment2 Interventions
Group XXVIII: B3: Nivolumab + Ipilimumab + TrametinibExperimental Treatment3 Interventions
Group XXIX: B2: Nivolumab + Ipilimumab + CabozantinibExperimental Treatment3 Interventions
Group XXX: B1: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group XXXI: A2: Nivolumab Monotherapy Dose 2Experimental Treatment1 Intervention
Group XXXII: A1: Nivolumab Monotherapy Dose 1Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Sunitinib
2014
Completed Phase 3
~4380
Fluorouracil
2014
Completed Phase 3
~11540
Enzalutamide
2014
Completed Phase 4
~2760
Daratumumab
2014
Completed Phase 3
~1860
Ipilimumab
2014
Completed Phase 3
~2620
Pembrolizumab
2017
Completed Phase 2
~2010
Trametinib
2014
Completed Phase 2
~1550
Leucovorin
2005
Completed Phase 4
~5730
Nivolumab
2014
Completed Phase 3
~4750
Pemetrexed
2014
Completed Phase 3
~5250
Relatlimab
2018
Completed Phase 2
~1120
Temozolomide
2010
Completed Phase 3
~1930
Rucaparib
2016
Completed Phase 3
~1990
Bevacizumab
2013
Completed Phase 4
~5280
Cabozantinib
2020
Completed Phase 2
~1080
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
10,171 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
203,571 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,719,535 Total Patients Enrolled

Media Library

Cancer Research Study Groups: C7: Relatlimab + Nivolumab SAV Dose 3, C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2, B2: Nivolumab + Ipilimumab + Cabozantinib, A2: Nivolumab Monotherapy Dose 2, B3: Nivolumab + Ipilimumab + Trametinib, C12: Relatlimab + Nivolumab SAV Dose 5, B1: Nivolumab + Ipilimumab, C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1, C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1, C4: Relatlimab + Nivolumab SAV Dose 2, C5: Relatlimab + Nivolumab + Ipilimumab, C6: Relatlimab + Nivolumab + Capecitabine, C10: Relatlimab + Nivolumab SAV Dose 4, E5: Enzalutamide Monotherapy, C9: Relatlimab + Nivolumab SAV + Bevacizumab, D1: Nivolumab + Temozolomide, D2: Nivolumab + Rucaparib, E7: Rucaparib Monotherapy, E10: Pemetrexed Monotherapy, A1: Nivolumab Monotherapy Dose 1, E6: Sunitinib Monotherapy, E9: Cabozantinib Monotherapy, D4: Nivolumab + Bevacizumab, D3: Nivolumab + Daratumumab, E2: Regorafinib Monotherapy, E4: Leucovorin + Oxaliplatin + Fluorouracil, E8: Capecitabine Monotherapy, E3: Leucovorin + Fluorouracil, E11: Pembrolizumab Monotherapy, C11: Relatlimab + Nivolumab SAV + PDCT Dose 2, E1: Bevacizumab Monotherapy, C8: Relatlimab + Nivolumab SAV + PDCT Dose 1
Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03899155 — Phase 2
Cancer Patient Testimony for trial: Trial Name: NCT03899155 — Phase 2

Frequently Asked Questions

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

Has Nivolumab received regulatory approval from the FDA?

"Nivolumab's score of 2 on our 1-to-3 scale reflects that, while there is some evidence supporting its safety, this medication has not yet been proven effective."

Answered by AI

Are there any precedents for Nivolumab's use in treatment?

"Nivolumab was first studied in 2010 and, as of now, there are 249 completed clinical trials. There are 747 more active studies currently underway, a large number of which taking place in Baltimore, Maryland."

Answered by AI

What makes this trial unique compared to others?

"Nivolumab has been the subject of 747 clinical trials in 2347 cities and 50 countries since 2010. The first trial, which was conducted by Medarex and completed Phase 1 drug approval in 2010, involved 127 participants. In the nine years since then, there have been 249 additional Nivolumab trials."

Answered by AI

Is this a widespread study taking place in the US?

"To make participation as easy as possible, this trial is currently recruiting out of 43 sites. The locations are located in Baltimore, Westwood and Tampa along with other locations. It is important to select the location closest you to minimize travel requirements if you participate."

Answered by AI

How many people are the researchers testing this on?

"That is accurate. The clinicaltrials.gov webpage for this research indicates that it is currently recruiting patients. 43 medical facilities are enrolling a total of 800 individuals in the study, which was initially posted on August 9th, 2019."

Answered by AI

What cancers has Nivolumab been known to be effective against?

"Nivolumab is most often used as a treatment for cancer, but it can also be administered to patients with other conditions like unresectable melanoma or squamous cell carcinoma."

Answered by AI

Are we still looking for more test subjects for this experiment?

"Yes, as of 10/25/2022 this trial is still recruiting patients from 43 different sites. In total, they are looking for 800 participants to enroll."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

study involves drug related to dostarlimab.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Pan Tumor Rollover Study
2019. "Pan Tumor Rollover Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03899155.
All > Sutent
~787 spots leftby Aug 2029
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