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Checkpoint Inhibitor

Relatlimab + Nivolumab for Advanced Melanoma (RELATIVITY-047 Trial)

Phase 2 & 3
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
Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to approximately 3 years
Awards & highlights

RELATIVITY-047 Trial Summary

This trial will compare the effectiveness of two drugs for treating melanoma that has spread or cannot be removed by surgery.

Who is the study for?
This trial is for individuals with advanced melanoma that can't be removed by surgery or has spread, and who haven't had previous systemic cancer treatments. They must have a confirmed diagnosis of Stage III (unresectable) or Stage IV melanoma and provide tumor tissue for analysis. People with active brain metastases, uveal melanoma, or autoimmune diseases cannot participate.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining two drugs: Relatlimab and Nivolumab versus using Nivolumab alone in treating advanced melanoma. The goal is to see if the combination works better than just one drug on its own.See study design
What are the potential side effects?
Potential side effects from Relatlimab and Nivolumab may include immune-related reactions such as inflammation in various organs, skin rash, hormone gland problems, infusion-related reactions, fatigue, and flu-like symptoms.

RELATIVITY-047 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My melanoma is at an advanced stage and cannot be surgically removed.
Select...
I have not received systemic anticancer therapy for my advanced melanoma.
Select...
I can provide a tissue sample from my cancer that cannot be surgically removed.

RELATIVITY-047 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to approximately 3 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
Progression Free Survival (PFS)
Secondary outcome measures
Overall Response Rate (ORR)
Overall Survival (OS)
Other outcome measures
The Number of Participant Deaths in the Study
The Number of Participants Experiencing Adverse Events (AEs)
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
+3 more

Side effects data

From 2022 Phase 1 & 2 trial • 578 Patients • NCT02488759
41%
Diarrhoea
36%
Nausea
35%
Fatigue
32%
Anaemia
28%
Constipation
26%
Pruritus
25%
Vomiting
25%
Pyrexia
24%
Decreased appetite
23%
Urinary tract infection
23%
Hypothyroidism
23%
Abdominal pain
20%
Arthralgia
19%
Rash maculo-papular
17%
Headache
17%
Asthenia
17%
Alanine aminotransferase increased
16%
Malignant neoplasm progression
16%
Hyperthyroidism
15%
Aspartate aminotransferase increased
15%
Oedema peripheral
14%
Back pain
13%
Cough
13%
Lipase increased
13%
Hypomagnesaemia
12%
Rash
12%
Hypoalbuminaemia
11%
Hyponatraemia
11%
Hypokalaemia
11%
Dizziness
10%
Blood creatinine increased
10%
Dyspnoea
9%
Amylase increased
9%
Dry skin
8%
Pneumonitis
8%
Colitis
8%
Myalgia
7%
Hyperglycaemia
7%
Pain in extremity
7%
Chills
6%
Upper respiratory tract infection
6%
Acute kidney injury
6%
Weight decreased
6%
Insomnia
5%
Blood alkaline phosphatase increased
5%
Hepatotoxicity
5%
Dyspepsia
5%
Flank pain
5%
Pelvic pain
5%
Dry mouth
5%
Vaginal haemorrhage
5%
Productive cough
5%
Intestinal obstruction
4%
Abdominal pain upper
4%
Mucosal inflammation
4%
Hypertension
4%
Lymphoedema
3%
Pain
3%
Nasal congestion
3%
Pyelonephritis
3%
Peripheral sensory neuropathy
3%
Anxiety
3%
Stomatitis
3%
White blood cell count decreased
3%
Sepsis
3%
Infusion related reaction
3%
Hypercalcaemia
3%
Hypotension
3%
Muscular weakness
2%
Gastritis
2%
Hypertransaminasaemia
2%
Musculoskeletal chest pain
2%
Lymphocyte count decreased
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Dehydration
2%
Paraesthesia
2%
Hypophysitis
2%
Hypophosphataemia
2%
Infected neoplasm
2%
Non-cardiac chest pain
2%
Hydronephrosis
2%
Respiratory tract infection
2%
Rhinitis
2%
Immune-mediated enterocolitis
2%
Skin infection
2%
Procedural pain
2%
Influenza like illness
2%
Tumour pain
2%
Female genital tract fistula
2%
Dysgeusia
2%
Transaminases increased
2%
Oropharyngeal pain
2%
Confusional state
2%
Pulmonary embolism
2%
Dysphagia
2%
Groin pain
2%
Autoimmune hepatitis
2%
Cardiac arrest
2%
Ileus
2%
Fall
2%
Musculoskeletal pain
2%
Pericardial effusion
1%
Septic shock
1%
Lung adenocarcinoma
1%
Ear pain
1%
Night sweats
1%
Sudden death
1%
Small intestinal obstruction
1%
Asthma
1%
Fistula
1%
Autoimmune nephritis
1%
Uveitis
1%
Haematuria
1%
Deep vein thrombosis
1%
Vertigo
1%
Pyelonephritis acute
1%
Tumour haemorrhage
1%
Pneumothorax
1%
Tongue ulceration
1%
Face oedema
1%
Ureteric stenosis
1%
Skin ulcer
1%
Upper-airway cough syndrome
1%
Neck pain
1%
Oesophagitis
1%
Hepatitis
1%
Soft tissue infection
1%
Tuberculosis
1%
Diabetic ketoacidosis
1%
Dyspnoea exertional
1%
Myocarditis
1%
Pancreatitis
1%
Encephalitis
1%
Rash pruritic
1%
Death
1%
Kidney infection
1%
Recall phenomenon
1%
Blood magnesium decreased
1%
Liver function test increased
1%
Bell's palsy
1%
Device occlusion
1%
Urinary retention
1%
Urinary tract obstruction
1%
Immune-mediated lung disease
1%
Pleural effusion
1%
Chest pain
1%
Anorectal disorder
1%
Thyroid disorder
1%
Abdominal distension
1%
Anal fistula
1%
Inappropriate antidiuretic hormone secretion
1%
Autoimmune cholangitis
1%
Hepatic function abnormal
1%
Hypersensitivity
1%
Pneumonia
1%
Bronchitis
1%
Lymph node pain
1%
Performance status decreased
1%
Systemic inflammatory response syndrome
1%
Urosepsis
1%
Fracture
1%
Encephalopathy
1%
Ascites
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metastatic Combo B
Metastatic Combo D
Metastatic Monotherapy
Neoadjuvant
Metastatic Combo C
Metastatic Combo A

RELATIVITY-047 Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: NivolumabExperimental Treatment1 Intervention
Monotherapy
Group II: Arm A: Relatlimab + NivolumabExperimental Treatment2 Interventions
Combination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Relatlimab
2018
Completed Phase 2
~1110

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,125,822 Total Patients Enrolled
177 Trials studying Melanoma
56,852 Patients Enrolled for Melanoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03470922 — Phase 2 & 3
Melanoma Research Study Groups: Arm A: Relatlimab + Nivolumab, Arm B: Nivolumab
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03470922 — Phase 2 & 3
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03470922 — Phase 2 & 3

Frequently Asked Questions

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

Are people being recruited for this study right now?

"Currently, this clinical trial is not looking for more participants. However, this may change in the future as the study was last updated on September 8th, 2022. Additionally, there are 1530 other trials that are presently accepting patients."

Answered by AI

What are the origins of this clinical trial?

"Relatlimab has been under investigation for a decade. In 2010, Medarex ran the first clinical trial with 127 participants. Based on the success of this study, Relatlimab received Phase 1 drug approval. At present, there are 749 active trials in 2348 cities and 50 countries."

Answered by AI

How many individuals are enrolled in this clinical trial?

"Recruitment for this trial has ceased. The listing was first published on April 11th, 2018 and underwent its final edit on September 8th, 2022. There are 781 and 749 studies currently recruiting patients with melanoma and Relatlimab respectively."

Answered by AI

What is Relatlimab's primary therapeutic purpose?

"Relatlimab is an immunotherapy medication that can be used to treat a patient suffering from malignant neoplasms, unresectable melanoma, or squamous cell carcinoma."

Answered by AI

Are there any other drugs in development that are similar to Relatlimab?

"Relatlimab was first studied a decade ago, at H. Lee Moffitt Cancer Center and Research Institute. So far, there is a body of 249 completed studies to draw data from. Additionally, there are 749 active clinical trials involving relatlimab with many of these being performed in Montreal, Quebec."

Answered by AI

In how many different medical settings is this research project being conducted today?

"Patients are currently being accepted at 50 different institutions across North America, including Local Institution - 0075 in Montreal, Quebec, Local Institution - 0120 in Baltimore, Maryland and Local Institution - 0018 in Charlotte, North carolina."

Answered by AI
~103 spots leftby Mar 2025