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Checkpoint Inhibitor

Immunotherapy for Renal Medullary Carcinoma

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 year
Awards & highlights

Study Summary

This trial will test if a combination of two drugs can help control RMC that has spread.

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.Check my eligibility
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.See study design
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 agree to use effective contraception during and for 7 months after my nivolumab treatment.
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My organs and bone marrow are functioning well.
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I am 18 years old or older.
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I had COVID-19 but recovered over 30 days ago with no symptoms or a negative test.
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It doesn't matter if my kidney tumor has been removed or not.
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I am not sexually active with men, so I don't need birth control.
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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.
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My brain cancer was treated with surgery or targeted radiation and has been stable for at least 1 month.
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I may or may not have had previous treatments for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To establish the objective response rate (ORR) of patients with locally advanced or metastatic RMC treated with combination nivolumab plus relatlimab.

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Superior vena cava syndrome
1%
Syncope
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Lung cancer metastatic
1%
Cancer pain
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,334 Total Patients Enrolled
Pavlos Msaouel, MD,PHD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05347212 — Phase 2
Renal Medullary Carcinoma Research Study Groups: Nivolumab+Relatlimab
Renal Medullary Carcinoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05347212 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05347212 — Phase 2

Frequently Asked Questions

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

What is the FDA's opinion on Nivolumab?

"Nivolumab has received a score of 2 from our team at Power. This is because, although there is some data supporting safety, none of it points to the drug's efficacy in Phase 2 trials."

Answered by AI

Is this study still enrolling new participants?

"The most recent information on clinicaltrials.gov suggests that this study is still actively looking for participants. The trial was originally posted on 9/22/2022 and there have been no changes since then."

Answered by AI

How many patients are being monitored in this clinical trial?

"Yes, that is correct. The listing on clinicaltrials.gov currently says that this study is looking for 30 more participants and is doing so at 1 site."

Answered by AI
~20 spots leftby Jul 2027