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Checkpoint Inhibitor
Relatlimab + Nivolumab for Lymphoma (RELATIVITY-069 Trial)
Phase 1 & 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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from the last treatment of last participant
Awards & highlights
RELATIVITY-069 Trial Summary
This trial is testing a new combination of two drugs to treat cancer in young people.
Who is the study for?
This trial is for young individuals with high-risk, recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma who haven't responded to standard therapy. They must have measurable disease confirmed by PET scan and not have had certain prior treatments like anti-CTLA-4 antibodies or stem cell transplants.Check my eligibility
What is being tested?
The study tests the combination of Relatlimab plus Nivolumab in pediatric and young adult patients. It aims to determine how safe this combo is, how well it's tolerated, what levels of the drugs stay in the body, and if it effectively treats these types of lymphomas.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting different organs, infusion-related symptoms such as fever or chills, fatigue, possible changes in blood counts leading to increased infection risk or bleeding tendencies.
RELATIVITY-069 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from the last treatment of last participant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from the last treatment of last participant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Curve within a dosing interval (AUC(TAU))
Complete Metabolic Response (CMR) Rate defined as the proportion of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria
Incidence of dose-limiting toxicities (DLTs)
+6 moreSecondary outcome measures
Number of deaths
Number of participants with AEs
Number of participants with AEs leading to discontinuation
+3 moreSide effects data
From 2023 Phase 1 & 2 trial • 62 Patients • NCT0331061962%
Neutropenia
54%
Thrombocytopenia
46%
Fatigue
38%
Nausea
38%
Anaemia
38%
Dizziness
31%
Back pain
31%
Leukopenia
23%
Decreased appetite
23%
Lymphopenia
23%
Hypophosphataemia
23%
Diarrhoea
23%
Arthralgia
23%
Cytokine release syndrome
23%
Constipation
15%
Night sweats
15%
Weight decreased
15%
Neurotoxicity
15%
Tremor
15%
Dysarthria
15%
Dysphonia
15%
Muscular weakness
15%
Cough
15%
Hypotension
15%
Contusion
15%
Vomiting
15%
Sinusitis
15%
Candida infection
15%
Ecchymosis
8%
International normalised ratio increased
8%
Mastication disorder
8%
Benign prostatic hyperplasia
8%
Erythema
8%
Confusional state
8%
Brain fog
8%
Pruritus
8%
Dry mouth
8%
Viral infection
8%
Joint swelling
8%
Epistaxis
8%
Dermatitis acneiform
8%
Rash
8%
Liver function test increased
8%
Deep vein thrombosis
8%
Flushing
8%
Haematoma
8%
Paraesthesia
8%
Thrombophlebitis
8%
Haemorrhage intracranial
8%
Hyperkalaemia
8%
Hyporeflexia
8%
Acute kidney injury
8%
Abdominal distension
8%
Hypoalbuminaemia
8%
Vulvitis
8%
Bone pain
8%
Atrial fibrillation
8%
Orthostatic hypotension
8%
Coccydynia
8%
Neuropathy peripheral
8%
Dry eye
8%
Non-cardiac chest pain
8%
Oedema peripheral
8%
Blood creatinine increased
8%
Resting tremor
8%
Pollakiuria
8%
Agitation
8%
Delirium
8%
Depression
8%
Libido decreased
8%
Febrile neutropenia
8%
Pneumonia
8%
Abdominal pain
8%
Mucosal inflammation
8%
Swelling
8%
Hyponatraemia
8%
Headache
8%
Gastrooesophageal reflux disease
8%
Dry skin
8%
Ileus
8%
Hyperbilirubinaemia
8%
Pain in extremity
8%
Urinary tract pain
8%
Colitis ischaemic
8%
Intention tremor
8%
Anxiety
8%
Prostatic specific antigen increased
8%
Haematuria
8%
Hypokalaemia
8%
Myalgia
8%
Wheezing
8%
Hypervolaemia
8%
Oropharyngeal pain
8%
Influenza
8%
Aspartate aminotransferase increased
8%
Dehydration
8%
Infusion related reaction
8%
Limb discomfort
8%
Sinus tachycardia
8%
Pain
8%
Dyspnoea
8%
Tachypnoea
8%
Gastrointestinal haemorrhage
8%
Mesenteric artery stenosis
8%
Hypocalcaemia
8%
Hypomagnesaemia
8%
Rhinitis allergic
8%
Upper-airway cough syndrome
8%
Rash pruritic
8%
Alanine aminotransferase increased
8%
Rhinorrhoea
8%
Cerumen impaction
8%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
RELATIVITY-069 Trial Design
1Treatment groups
Experimental Treatment
Group I: Relatlimab + NivolumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relatlimab
2018
Completed Phase 2
~1120
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,646 Previous Clinical Trials
4,131,074 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is an aggressive B-cell lymphoma, such as Burkitt lymphoma.My lymphoma affects my brain, spinal cord, or has spread within its coverings.I have been treated with drugs targeting LAG-3.I have had a stem cell transplant using my own cells.I have had a bone marrow transplant from another person.My cancer shows up on PET scans.I have been treated with specific immune system targeting drugs, except anti-PD(L)-1 therapies.My lymphoma has not improved after second-line treatment.My Hodgkin lymphoma did not respond to the first standard treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Relatlimab + Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently partaking in this experiment?
"Bristol-Myers Squibb is coordinating the trial, which necessitates that 68 suitable patients are recruited. To facilitate this process, Nemours Childrens Hospital in Wilmington and a Local Institution in Valhalla have been selected as potential sites for enrolment."
Answered by AI
Is this experiment actively recruiting participants?
"Affirmative. As evinced by the information on clinicaltrials.gov, this study is actively enrolling participants and was first listed online in September 13th 2022. A total of 68 people are needed across 14 different medical sites for this trial to be successful."
Answered by AI
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