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Checkpoint Inhibitor
Nivolumab + Vorolanib for Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Leora Horn, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having progressed on at least one prior line of therapy, or refused chemotherapy, histologically or cytologically confirmed diagnosis of specific cancer types
Men not azoospermic who are sexually active with women of childbearing potential must agree to follow instructions for acceptable contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new combination treatment for lung cancer patients who have not responded to other treatments.
Who is the study for?
Adults with certain thoracic tumors, including various types of lung cancer and thymic carcinoma, who have previously undergone treatment or refused chemotherapy. Participants must not be pregnant or breastfeeding, agree to use contraception if applicable, have at least one measurable lesion, good organ function, and a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory.Check my eligibility
What is being tested?
The trial is testing the combination of oral Vorolanib and infusional Nivolumab in patients with different stages of lung cancer and thymic carcinoma. It's an open-label study where everyone knows what treatment they're getting; it includes dose escalation to find the right amount followed by expansion to see how well it works.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to Nivolumab affecting organs like lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies) as well as skin rash and infusion-related reactions. Vorolanib could cause high blood pressure, diarrhea, fatigue among other symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened after treatment or I refused chemotherapy.
Select...
I am a man who can father children and will use birth control.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase II best response
Phase II best response per Response Evaluation Criteria in Solid Tumors (RECIST)
Phase II recommended combination dose per Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.03
Secondary outcome measures
Disease control rate
Objective response rate as related to PD-L1 status measured as < 1%, 1-49%, and > 50%.
Overall survival
+1 moreSide 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%
Hyponatraemia
14%
Rash
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%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
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%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Circulatory collapse
1%
Confusional state
1%
Pericardial effusion malignant
1%
Syncope
1%
Hypercalcaemia
1%
Femur fracture
1%
Superior vena cava syndrome
1%
Bronchial obstruction
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
6Treatment groups
Experimental Treatment
Group I: EscalationExperimental Treatment2 Interventions
Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
Group II: Dose Expansion - Thymic CarcinomaExperimental Treatment2 Interventions
Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
Group III: Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based ChemotherapyExperimental Treatment2 Interventions
Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
Group IV: Dose Expansion - Non Small-Cell-Lung Cancer Primary RefractoryExperimental Treatment2 Interventions
Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
Group V: Dose Expansion - Non Small-Cell-Lung Cancer NaiveExperimental Treatment2 Interventions
Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
Group VI: Dose Expansion - Non Small-Cell-Lung Cancer Acquired ResistanceExperimental Treatment2 Interventions
Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Xcovery Holdings, Inc.Industry Sponsor
9 Previous Clinical Trials
530 Total Patients Enrolled
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,845 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,645 Previous Clinical Trials
4,130,911 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer treatment in the last 14 days.I had radiosurgery or radiotherapy less than 14 days before starting the treatment.I have not started new treatments for anemia or bone loss within the last 2 weeks.I have a serious heart condition.I haven't had any cancer except for skin cancer in the last 5 years.I am currently on IV antibiotics for an infection.I haven't received G-CSF or GM-CSF treatments in the last 7 days.My cancer has worsened after treatment or I refused chemotherapy.I have not received a live vaccine in the week before starting the treatment.I am 18 years old or older.I agree to use birth control as advised if I can have children.I have wounds that are not healing.I am a man who can father children and will use birth control.I am not taking any strong CYP3A4 inhibitors or inducers.I still have side effects from previous cancer treatments.I am allergic to certain cancer treatments I've had before.My brain metastasis is stable and doesn't cause symptoms.I haven't taken steroids or immunosuppressants in the last 14 days.I do not have an active Hepatitis B or C infection.I have not had another type of cancer in the last 2 years.I do not have any serious or uncontrolled infections.I haven't had major surgery or a serious injury in the last 28 days.I have active lung inflammation or scarring.I have had a fever over 38.0 ºC without a known cause.My organs are functioning well enough for treatment.I haven't taken bevacizumab for cancer in the last 28 days.I cannot swallow pills or have a severe gut problem.I had a clot in my leg or lung less than 4 weeks ago but am now treated and stable.I have had a condition where my lymphocytes grow abnormally.You have been diagnosed with HIV or AIDS.I am currently experiencing or at risk of significant bleeding.I have an autoimmune disease.I have had a solid tumor transplant.You have at least one visible and measurable tumor according to specific medical guidelines.I am fully active or restricted in physically strenuous activity but can do light work.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other scientific trials that have been conducted related to Nivolumab?
"Nivolumab, which was initially introduced to research in 2012 by Local Institution, has already seen 252 clinical trials concluded. Of the 718 active studies taking place now, a substantial amount are concentrated around Philadelphia, Pennsylvania."
Answered by AI
How many participants are involved in this medical experiment?
"This clinical trial is not presently recruiting participants. The information was initially posted on July 10th 2018 and the record was last revised on September 21st 2022. If you are investigating other studies, there are 1,701 medical trials actively accepting patients with small cell lung carcinoma and 718 for Nivolumab which require volunteers."
Answered by AI
Is this an innovative exploration of the subject?
"In the 8 years since its initial trial in 2012, Nivolumab has been studied extensively. Presently there are 718 active clinical trials for this drug across 2356 cities in 49 countries. Initially sponsored by Ono Pharmaceutical Co Ltd., it involved 659 participants and successfully passed Phase 1 & 2 of approval stages. In total, 252 studies have been conducted concerning this medication up to now."
Answered by AI
What are the typical ailments that Nivolumab is employed to address?
"Nivolumab is suitable for treating cancerous tumours, as well as unresectable melanoma, esophageal adenocarcinoma with metastasis, and squamous cell carcinomas."
Answered by AI
Is there an opportunity for individuals to currently join this investigation?
"This clinical trial is not presently enrolling candidates. It was first posted on July 10th 2018 and had its last edit done on September 21st 2022. If you seek other studies, there are 1,701 trials actively recruiting participants with small cell lung carcinoma, as well as 718 offering Nivolumab treatments."
Answered by AI
Are there numerous healthcare facilities administering this research across North America?
"The 8 medical centres hosting this clinical trial include Fox Chase Cancer Center in Philadelphia, Stanford Cancer Institute in Palo Alto, and Providence Cancer Institute Franz Clinic located in Portland. Additionally, there are 5 more places across the United States that are accepting participants for this study."
Answered by AI
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