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Alkylating agents
Nivolumab + Chemotherapy for Mesothelioma
Phase 1
Waitlist Available
Led By Michael Offin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Karnofsky performance status > 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days of the initially planned date
Awards & highlights
Study Summary
This trial will test a new combo therapy for mesothelioma that could make surgery safer and more effective.
Who is the study for?
This trial is for adults with resectable malignant pleural mesothelioma. Participants must have a performance status indicating they are relatively active, agree to contraception if of childbearing potential, and not be pregnant or breastfeeding. They should not have had prior chemo or immunotherapy for mesothelioma, no serious illnesses or other cancers requiring treatment, and no active hepatitis B/C or HIV.Check my eligibility
What is being tested?
The study tests the combination of Nivolumab (an immunotherapy drug) with chemotherapy drugs Pemetrexed and either Cisplatin or Carboplatin before surgery in patients with mesothelioma. It aims to determine if this approach is safe and effective without delaying surgical intervention.See study design
What are the potential side effects?
Nivolumab can cause immune-related side effects like inflammation in various organs, skin reactions, hormonal gland problems leading to hormone deficiencies. Chemotherapies such as Cisplatin/Carboplatin and Pemetrexed may cause nausea, kidney damage, low blood cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am mostly independent and can care for myself.
Select...
I have been diagnosed with cancer in the lining of my lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days of the initially planned date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days of the initially planned date
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients going to operating room for surgical resection
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%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
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%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Neoplasm progression
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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 with pemetrexed and cisplatin or carboplatinExperimental Treatment3 Interventions
Eligible patients will receive two cycles of neoadjuvant therapy with nivolumab 360 mg, pemetrexed 500 mg/m2, and cisplatin 75 mg/m2 or carboplatin AUC=5. Subsequently, they will undergo pleurectomy/decortication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin or Carboplatin
2015
Completed Phase 2
~90
Nivolumab
2014
Completed Phase 3
~4750
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,492 Total Patients Enrolled
14 Trials studying Mesothelioma
1,922 Patients Enrolled for Mesothelioma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,598 Total Patients Enrolled
19 Trials studying Mesothelioma
775 Patients Enrolled for Mesothelioma
Michael Offin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
2 Total Patients Enrolled
1 Trials studying Mesothelioma
2 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgeon believes my condition can be treated with surgery.I have received chemotherapy or immunotherapy for mesothelioma.I currently have lung inflammation.I can provide tissue samples for the study, either from previous procedures or by undergoing a new biopsy if safe.You have a negative HIV blood test.I agree to use effective birth control during and after the study as required.I am 18 years old or older.I do not have any serious illnesses or other cancers needing treatment.I agree to use effective birth control during and after the study as required.You have enough infection-fighting white blood cells in your body.Women who could become pregnant must have a negative pregnancy test.Your creatinine levels in the blood are within a certain range.I am mostly independent and can care for myself.I have been diagnosed with cancer in the lining of my lungs.I am currently taking 10 mg or more of prednisone daily.I have been treated for an autoimmune disease with immune-modifying drugs in the last 2 years.I have active hepatitis B or C.Your liver enzymes (AST and ALT) are not more than 3 times the normal limit.Your total bilirubin level should be no higher than 1.5 mg/dl.
Research Study Groups:
This trial has the following groups:- Group 1: nivolumab with pemetrexed and cisplatin or carboplatin
Awards:
This trial has 1 awards, including:- 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.
How many participants are being recruited to participate in this investigation?
"Confirmed. Clinicaltrials.gov states that this study, which was initially posted on November 12th 2019, is actively enrolling people in need of help. 35 patients are needed from 7 different medical centres to participate in the trial."
Answered by AI
In what locales are the experiments related to this study taking place?
"This clinical trial is presently endeavouring to find participants from 7 different sites with 4 of them in Commack, Middletown and Harrison. To reduce traveling costs if you join the study, it's best to pick a clinic near your location."
Answered by AI
What pathologies has Nivolumab been approved to address?
"Nivolumab is often prescribed to treat cancers, including unresectable melanoma and squamous cell carcinoma. Additionally, it may be beneficial for those with locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
Does this trial still have open spots for participants?
"Affirmative. Clinicaltrials.gov reveals that this investigation is recruiting participants at the present time, with 35 people sought from 7 distinct sites since it was first made public on November 12th 2019 and last modified on January 26th 2022."
Answered by AI
Are there any other documented research studies that have tested Nivolumab as a treatment?
"Nivolumab was first tested in 1997 at City of Hope Comprehensive Cancer Center; since then, 2003 trials have been completed and 1819 are ongoing. A bulk of these studies are currently being conducted out of Commack, New jersey."
Answered by AI
What risks are associated with Nivolumab treatment?
"Since Nivolumab is still in its first clinical trial, the safety rating of this treatment was conservatively assessed as 1. This assessment reflects the limited amount of data available to ascertain both efficacy and safety."
Answered by AI
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