What side effects are associated with this type of intervention?

Common side effects of treatments for Hodgkin's Lymphoma, particularly those involving immune checkpoint inhibitors like Relatlimab (LAG-3 Inhibitor) and Nivolumab (PD-1 Inhibitor), include fatigue, rash, diarrhea, and pruritus. More severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. The combination of these inhibitors may increase the risk and severity of these immune-related adverse events.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of Hodgkin's Lymphoma. Notably, nivolumab (a PD-1 inhibitor) and pembrolizumab (another PD-1 inhibitor) have been approved for patients with relapsed or refractory classical Hodgkin's Lymphoma. These approvals are based on their ability to block the PD-1 pathway, thereby enhancing the immune system's ability to fight cancer. The combination of relatlimab (a LAG-3 inhibitor) and nivolumab (a PD-1 inhibitor) being studied in the trial represents a novel approach by targeting multiple immune checkpoints to potentially improve treatment efficacy.

What other types of research exist?

Promising alternatives to Relatlimab plus Nivolumab for Hodgkin's Lymphoma include Pembrolizumab (PD-1 inhibitor) monotherapy or in combination with chemotherapy, and the combination of Brentuximab Vedotin (an antibody-drug conjugate targeting CD30) with Nivolumab. These alternatives have shown efficacy in clinical trials and are considered viable options for treatment.

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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

Must not have

Aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia

Primary CNS lymphoma of the brain or spinal cord, and secondary CNS lymphoma (ie, from systemic non-Hodgkin lymphoma) involving the brain, spinal cord, or with leptomeningeal seeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 135 days following last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two drugs, relatlimab and nivolumab, in children and young adults whose lymphoma has come back or didn't respond to other treatments. These drugs help the immune system recognize and attack cancer cells. The study aims to see if this combination is safe and effective. Nivolumab has demonstrated clinical benefits in multiple tumors, including classical Hodgkin lymphoma.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is an aggressive B-cell lymphoma, such as Burkitt lymphoma.

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My lymphoma affects my brain, spinal cord, or has spread within its coverings.

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I have been treated with drugs targeting LAG-3.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 135 days following last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 135 days following last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 135 days following last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose-limiting toxicities (DLTs)

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619

71%

White blood cell count decreased

65%

Neutrophil count decreased

59%

Anaemia

59%

Lymphocyte count decreased

53%

Platelet count decreased

41%

Cytokine release syndrome

29%

Neutropenia

29%

Decreased appetite

18%

Diarrhoea

18%

Vomiting

18%

Muscular weakness

18%

Dizziness

18%

Neurotoxicity

18%

Insomnia

18%

Pleural effusion

18%

Hypertension

12%

Pyrexia

12%

Hypoxia

12%

Febrile neutropenia

12%

Thrombocytopenia

12%

Tachycardia

12%

Conjunctival haemorrhage

12%

Fatigue

12%

Pain

12%

Contusion

12%

Hyperuricaemia

12%

Hypokalaemia

12%

Hypomagnesaemia

12%

Tremor

12%

Dyspnoea

12%

Pruritus

Appetite disorder

Extrasystoles

Hypercalcaemia

Atrial fibrillation

Blood creatinine increased

Enteritis

COVID-19

Pneumonia

Agraphia

Large intestine perforation

Hypofibrinogenaemia

Supraventricular extrasystoles

Ventricular tachycardia

Periorbital oedema

Visual impairment

Abdominal distension

Abdominal pain

Anal incontinence

Constipation

Dry mouth

Gastrointestinal disorder

Oedema

Oedema peripheral

Physical deconditioning

Jaundice

Ocular icterus

Conjunctivitis

Cytomegalovirus infection reactivation

Urinary tract infection

Fall

Alanine aminotransferase increased

Blood bilirubin increased

Dehydration

Hypocalcaemia

Hypophosphataemia

Arthralgia

Musculoskeletal chest pain

Amnesia

Peroneal nerve palsy

Anxiety

Confusional state

Urinary retention

Cough

Oropharyngeal pain

Night sweats

Seborrhoeic dermatitis

Deep vein thrombosis

Haematoma

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)

Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)

Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Nivolumab

2015

Completed Phase 3

~4010

Relatlimab

2019

Completed Phase 2

~1150

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Hodgkin's Lymphoma, such as immune checkpoint inhibitors, work by enhancing the body's immune response against cancer cells. Relatlimab (a LAG-3 inhibitor) and Nivolumab (a PD-1 inhibitor) are examples of such treatments. Relatlimab blocks LAG-3, a protein that reduces T-cell activity, while Nivolumab blocks PD-1, a protein that prevents T-cells from attacking cancer cells. By inhibiting these proteins, these drugs help the immune system better recognize and destroy cancer cells, offering new hope for patients with recurrent or refractory Hodgkin's Lymphoma.