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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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from the last treatment of last participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from the last treatment of last participant for reporting.

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 more
Secondary outcome measures
Number of deaths
Number of participants with AEs
Number of participants with AEs leading to discontinuation
+3 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619
36%
Vomiting
36%
Thrombocytopenia
36%
Nausea
27%
Fatigue
27%
Leukopenia
27%
Anaemia
27%
Hypokalaemia
18%
Hyperbilirubinaemia
18%
Neutropenia
18%
Rash
18%
Nasal discomfort
18%
Insomnia
18%
Hypomagnesaemia
18%
Musculoskeletal chest pain
9%
Squamous cell carcinoma of skin
9%
Blood alkaline phosphatase increased
9%
Encephalopathy
9%
Respiratory syncytial virus infection
9%
Upper respiratory tract infection
9%
Hypocalcaemia
9%
Ileus paralytic
9%
Enterocolitis
9%
Pyrexia
9%
Back pain
9%
Cellulitis
9%
Acute kidney injury
9%
Rash maculo-papular
9%
Abdominal pain
9%
Lymphopenia
9%
Pain
9%
Hypogammaglobulinaemia
9%
Cough
9%
Aspartate aminotransferase increased
9%
Hyponatraemia
9%
Headache
9%
Hypophosphataemia
9%
Dysphonia
9%
Oropharyngeal pain
9%
Hiatus hernia
9%
Arthralgia
9%
Nystagmus
9%
Sepsis
9%
Febrile neutropenia
9%
Bloody discharge
9%
Hypertension
9%
Neurotoxicity
9%
Acute respiratory failure
9%
Chapped lips
9%
Alanine aminotransferase increased
9%
Rhinorrhoea
9%
Pneumonia
9%
Asthenia
9%
Muscular weakness
9%
Abdominal pain upper
9%
Hypertriglyceridaemia
9%
Productive cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
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 D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (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
2,641 Previous Clinical Trials
4,129,996 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05255601 — Phase 1 & 2
Hodgkin's Lymphoma Research Study Groups: Relatlimab + Nivolumab
Hodgkin's Lymphoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05255601 — Phase 1 & 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05255601 — Phase 1 & 2

Frequently Asked Questions

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

How many healthcare facilities are involved in the implementation of this trial?

"This investigation has sites located in Nemours Childrens Hospital, Wilmington Delaware; Local Institution, Valhalla New york; and $Form.Name Arizona as well as 14 other clinics across the country."

Answered by AI

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
~45 spots leftby Jul 2028