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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 belowSelect...
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.
Select...
I agree to use effective contraception during and for 7 months after my nivolumab treatment.
Select...
My organs and bone marrow are functioning well.
Select...
I am 18 years old or older.
Select...
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.
Select...
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.
Select...
I can take care of myself and perform daily activities.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 year
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 • NCT0204153357%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.I have not received any live vaccines within a week of signing up or during the study.Your condition must have gotten worse after your last treatment.You have a positive COVID-19 test.My kidney cancer is advanced or has spread and shows medullary features.My cancer is advanced or has spread, and tests show a specific protein is missing.I agree to use effective contraception during and for 7 months after my nivolumab treatment.The levels of troponin T or troponin I in your blood are more than twice the normal limit at the hospital you are getting tested at.My organs and bone marrow are functioning well.I am not on any other treatments for kidney cancer.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I am 18 years old or older.I had COVID-19 but recovered over 30 days ago with no symptoms or a negative test.Women who could become pregnant must have a negative pregnancy test within a day before starting the study drug.I have not had major surgery or significant injury in the last 4 weeks.I have received an organ transplant from another person.It doesn't matter if my kidney tumor has been removed or not.I am not sexually active with men, so I don't need birth control.I haven't had any cancer except for certain skin cancers or cervical cancer in the last 2 years.I have not taken any cancer treatments in the last 2 weeks.I have an autoimmune disease.I am willing to provide a fresh biopsy of my tumor.I can take care of myself and perform daily activities.I don't have ongoing major side effects from previous treatments.My cancer has spread to my brain or its coverings and is not under control.I am taking high dose steroids or strong immune-suppressing drugs.I have an active inflammation of the heart muscle.My brain cancer was treated with surgery or targeted radiation and has been stable for at least 1 month.My heart's pumping ability is below 50% as shown in a recent test.You must have at least one place in your body where the disease can be measured.I may or may not have had previous treatments for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab+Relatlimab
Awards:
This trial has 2 awards, including:- 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.
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.
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
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