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Nivolumab for Cancer (FRACTION-RCC Trial)

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Awards & highlights

FRACTION-RCC Trial Summary

This trial is testing different combinations of the immunotherapy drugs nivolumab and ipilimumab to see which is more effective and has fewer side effects in treating advanced kidney cancer.

Eligible Conditions
  • Cancer

FRACTION-RCC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to 30 days after last dose of study therapy (approximately 108 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to 30 days after last dose of study therapy (approximately 108 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Duration of Response (DOR) Per Investigator
Objective Response Rate (ORR) Per Investigator
Progression Free Survival Rate (PFSR) at 24 Weeks.
Secondary outcome measures
Number of Participants Who Died
Number of Participants With Abnormal Hepatic Test Results - Track 1
Number of Participants With Abnormal Hepatic Test Results - Track 2
+5 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%
Hyperkalaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
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%
Sepsis
2%
Malignant pleural effusion
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%
Superior vena cava syndrome
1%
Bronchial obstruction
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

FRACTION-RCC Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + RelatlimabExperimental Treatment2 Interventions
Nivolumab + Relatlimab
Group II: Nivolumab + BMS-986205Experimental Treatment2 Interventions
Nivolumab + BMS-986205
Group III: Nivolumab + BMS-813160Experimental Treatment2 Interventions
Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
Group IV: Nivolumab + IpilimumabActive Control2 Interventions
Nivolumab + Ipilimumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Relatlimab
2018
Completed Phase 2
~1120
BMS-986205
2017
Completed Phase 3
~1200
BMS-813160
2010
Completed Phase 2
~590

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,642 Previous Clinical Trials
4,129,941 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
2017. "A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02996110.
~22 spots leftby May 2025
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