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Monoclonal Antibodies

Nivolumab + Ramucirumab for Mesothelioma

Phase 2

Waitlist Available

Led By Arkadiusz Z Dudek, MD

Research Sponsored by Arkadiusz Z. Dudek, MD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of treatment start until death or date of last contact, up to a maximum of 32 months.

Awards & highlights

Study Summary

This trial will test if a combo of two drugs can help people with mesothelioma who have already tried other treatments.

Eligible Conditions

Mesothelioma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of treatment start until death or date of last contact, up to a maximum of 32 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of treatment start until death or date of last contact, up to a maximum of 32 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of treatment start until death or date of last contact, up to a maximum of 32 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response Rate

Secondary outcome measures

Adverse Event Assessment

Overall Survival

Progression-free Survival (PFS)

Side effects data

From 2016 Phase 3 trial • 1253 Patients • NCT01168973

46%

Fatigue

36%

Neutropenia

32%

Diarrhoea

30%

Decreased appetite

27%

Nausea

26%

Alopecia

24%

Dyspnoea

23%

Stomatitis

22%

Cough

22%

Anaemia

19%

Epistaxis

18%

Neutrophil count decreased

17%

Oedema peripheral

17%

Constipation

16%

Mucosal inflammation

16%

Pyrexia

14%

Lacrimation increased

14%

Vomiting

14%

Febrile neutropenia

13%

Myalgia

13%

Leukopenia

12%

Peripheral sensory neuropathy

12%

Back pain

11%

Dysgeusia

11%

Hypertension

11%

Insomnia

11%

Headache

11%

Arthralgia

11%

Asthenia

11%

Weight decreased

Abdominal pain

White blood cell count decreased

Oropharyngeal pain

Pain in extremity

Thrombocytopenia

Rash

Dizziness

Nail discolouration

Dehydration

Pain

Dyspepsia

Haemoptysis

Paraesthesia

Dysphonia

Productive cough

Hyperglycaemia

Pneumonia

Platelet count decreased

Bone pain

Chronic obstructive pulmonary disease

Hyponatraemia

Metastatic pain

Lobar pneumonia

Pleural effusion

Pneumothorax

Pulmonary embolism

Pulmonary haemorrhage

Syncope

Confusional state

Death

Atrial fibrillation

General physical health deterioration

Renal failure acute

100%

80%

60%

40%

20%

Study treatment Arm

Ramucirumab and Docetaxel

Placebo and Docetaxel

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nivolumab + RamucirumabExperimental Treatment2 Interventions

Nivolumab 240mg IV + Ramucirumab 8mg/kg IV

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Ramucirumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Arkadiusz Z. Dudek, MDLead Sponsor

2 Previous Clinical Trials

67 Total Patients Enrolled

HealthPartners Institute Regions Cancer Care CenterUNKNOWN

Eli Lilly and CompanyIndustry Sponsor

2,618 Previous Clinical Trials

3,201,483 Total Patients Enrolled

10 Trials studying Mesothelioma

776 Patients Enrolled for Mesothelioma

Frequently Asked Questions

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

What are some other instances in which Ramucirumab has been tested?

"First studied in 2010, ramucirumab has completed 309 clinical trials as of now. Additionally, there are 792 active trials taking place globally--many of which are based in Tampa, Florida."

Answered by AI

What is the FDA's official stance on Ramucirumab?

"While there is some evidence to support the safety of Ramucirumab, it only received a score of 2 because this medication has not been proven effective yet in clinical trials."

Answered by AI

Have there been other trials like this one before?

"Ramucirumab has been researched for a decade. After the first study in 2010, which was sponsored by Medarex and included 127 participants, Ramucirumab received Phase 1 drug approval. As of now, there are 792 live trials for Ramucirumab being conducted in cities across 51 countries."

Answered by AI

Are new participants being accepted into this research project at this time?

"This particular clinical trial is no longer recruiting patients. The dates for this study were from June 26th, 2018 to August 1st, 2022. However, there are still 158 trials seeking patients with mesothelioma and 792 trials searching for participants that have malignant tumours."

Answered by AI

What are the most common reasons that patients are prescribed Ramucirumab?

"While malignant neoplasms is the primary indication for Ramucirumab, this medication can also offer relief to patients with unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Could you provide a number for how many different locations this trial is being conducted?

"Currently, Moffitt Cancer Center in Tampa, Karmanos Cancer Center (Wayne State University) in Detroit, and HealthPartners Institute Regions Cancer Care Center in Minneapolis are conducting this clinical trial. There 4 other locations running the trial as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma

Arkadiusz Z. Dudek, MD 2018. "Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03502746.

All > Mesothelioma