What side effects are associated with this type of intervention?

Common side effects of PD-1 inhibitors like Nivolumab include fatigue, rash, diarrhea, and immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. While specific data on LAG-3 inhibitors like Relatlimab is limited, potential side effects may overlap with those of other immune checkpoint inhibitors, including fatigue, rash, and immune-related adverse events. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Renal Medullary Carcinoma (RMC) in the provided context. However, immune checkpoint inhibitors such as Nivolumab (a PD-1 inhibitor) are being studied for their efficacy in treating RMC. The combination of Nivolumab and Relatlimab (a LAG-3 inhibitor) is currently under investigation in clinical trials for its potential to control locally advanced or metastatic RMC.

What other types of research exist?

Promising alternatives to Nivolumab and Relatlimab for Renal Medullary Carcinoma patients include combination therapies involving other immune checkpoint inhibitors such as Pembrolizumab (PD-1 inhibitor) and Avelumab (PD-L1 inhibitor). Additionally, targeted therapies like Cabozantinib (a tyrosine kinase inhibitor) and combination regimens involving anti-VEGF agents (e.g., Bevacizumab) with immune checkpoint inhibitors are also being explored for their potential efficacy in treating advanced renal cell carcinoma.

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Checkpoint Inhibitor

Immunotherapy for Renal Medullary Carcinoma

Phase 2

Waitlist Available

Led By Pavlos Msaouel, MD,PHD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype

Patients with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by immunohistochemistry

Must not have

Patients receiving any concomitant systemic therapy for renal cell cancer are excluded

Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing if a combination of two drugs, nivolumab and relatlimab, can help control a type of kidney cancer called renal medullary carcinoma that has spread or is hard to treat. These drugs work by helping the immune system recognize and attack cancer cells. The goal is to improve treatment outcomes. Nivolumab has been approved for the treatment of various cancers, including renal cell carcinoma, and is often used in combination therapies.

Who is the study for?

Adults with advanced or metastatic renal medullary carcinoma (RMC), who may or may not have had a kidney removed, and are not currently pregnant or breastfeeding. Participants need to have proper organ function, can be treatment-naïve or previously treated for RMC, and must agree to use effective contraception. Those with controlled brain metastases post-treatment are eligible; however, individuals with severe medical conditions, other recent cancers, HIV/AIDS, uncontrolled brain metastases, active myocarditis or hepatitis B/C infection cannot join.

What is being tested?

The trial is testing the effectiveness of combining two immunotherapy drugs—nivolumab and relatlimab—in treating RMC that has spread beyond the kidney. The study aims to see if this drug combination can control the disease's progression in patients who meet specific health criteria.

What are the potential side effects?

Potential side effects include immune-related reactions affecting different organs which could lead to inflammation issues such as colitis or hepatitis; skin problems like rash; endocrine disorders including thyroid dysfunction; fatigue; infusion-related reactions; and possibly increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney cancer is advanced or has spread and shows medullary features.

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My cancer is advanced or has spread, and tests show a specific protein is missing.

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I am 18 years old or older.

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I am willing to provide a fresh biopsy of my tumor.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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I am not on any other treatments for kidney cancer.

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I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.

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I have received an organ transplant from another person.

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I have not taken any cancer treatments in the last 2 weeks.

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I have an autoimmune disease.

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I don't have ongoing major side effects from previous treatments.

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My cancer has spread to my brain or its coverings and is not under control.

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I am taking high dose steroids or strong immune-suppressing drugs.

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I have an active inflammation of the heart muscle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: Nivolumab+RelatlimabExperimental Treatment2 Interventions

nivolumab 480 mg IV plus relatlimab 480 mg IV every 4 weeks for up to 2 years

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Relatlimab

FDA approved

0 / 14Eligibility 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

Renal Medullary Carcinoma (RMC) is often treated with immune checkpoint inhibitors, such as Nivolumab and Relatlimab. Nivolumab targets the PD-1 receptor on T-cells, preventing cancer cells from evading the immune response. Relatlimab inhibits LAG-3, another checkpoint that downregulates T-cell activity. By blocking these pathways, these drugs enhance the body's immune response against cancer cells. This is particularly important for RMC patients, as these tumors are typically resistant to conventional therapies, making immune checkpoint inhibitors a crucial option for potentially improving outcomes.

Assessment of prognostic factors in previously treated Japanese patients with metastatic renal cell carcinoma who received nivolumab: An observational multi-institute study.Nivolumab for the Treatment of Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma (nccRCC): A Single-Institutional Experience and Literature Meta-Analysis.Cabozantinib in advanced non-clear-cell renal cell carcinoma: a multicentre, retrospective, cohort study.