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Checkpoint Inhibitor
Vorolanib + Nivolumab for Thoracic Tumors
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
Small Cell Lung Cancer patients must have progressed on platinum-based chemotherapy and may have received up to three prior lines of therapy for stage IV disease provided no prior regimen included an oral VEGF TKI; prior regimens can include an anti-PD-1 or PD-L1 agent.
Checkpoint Inhibitor Naïve Non-Small Cell Lung Cancer patients must have progressed on front-line cytotoxic chemotherapy or have refused chemotherapy and may have received up to three prior treatment regimens for stage IV disease provided no regimens included an anti-PD1 or PD-L1 agent or an oral VEGF TKI. Prior bevacizumab or ramucirumab is allowed.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 2 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new combination treatment for lung cancer patients who have not responded to other treatments.
Eligible Conditions
- Refractory Thoracic Tumors
- Thymic Carcinoma
- Small Cell Lung Cancer
- Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
If you have Small Cell Lung Cancer, you must have tried platinum-based chemotherapy and up to three other treatments for stage IV cancer. However, you cannot have taken an oral VEGF TKI before. You can have taken an anti-PD-1 or PD-L1 medication before.
Select...
You have advanced lung cancer and have already received chemotherapy, but it didn't work or you declined it. You have not yet received any immunotherapy or certain targeted drugs. You may have received up to three different treatments for your cancer.
Select...
You have advanced non-small cell lung cancer and have already tried a certain type of immunotherapy called checkpoint inhibitor. You have also tried up to three other treatments for this stage of cancer, but none of them included a specific type of medication.
Select...
You have a specific type of lung cancer (NSCLC) with certain genetic mutations, and you have already tried medication taken by mouth for it. You may have also tried other treatments before.
Select...
You have a detectable and measurable tumor that can be monitored by CT or MRI scans using a specific set of criteria called RECIST 1.1.
Select...
You have enough infection-fighting white blood cells, specifically a count of at least 1,500 per microliter.
Select...
You have thymic carcinoma, but you cannot have surgery at the time of the study. You may have received other treatments before, but not ones that include certain drugs.
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%
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%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
10%
Alopecia
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
9%
Abdominal pain upper
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%
General physical health deterioration
2%
Atrial fibrillation
2%
Embolism
2%
Cardiac failure
2%
Adrenal insufficiency
2%
Sepsis
2%
Malignant pleural effusion
1%
Circulatory collapse
1%
Pancytopenia
1%
Atrial flutter
1%
Lung cancer metastatic
1%
Cancer pain
1%
Syncope
1%
Pericardial effusion
1%
Colitis
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal haemorrhage
1%
Small intestinal obstruction
1%
Performance status decreased
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Confusional state
1%
Bronchial obstruction
1%
Pneumothorax
1%
Respiratory tract infection
1%
Respiratory failure
1%
Superior vena cava syndrome
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~4120
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,974 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,601 Previous Clinical Trials
4,047,563 Total Patients Enrolled
Xcovery Holdings, INCUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known or suspected autoimmune disease that is currently active.You have had a solid tumor transplant.You have either tried and failed at least one type of treatment, or you have chosen not to receive chemotherapy.You are 18 years old or older, regardless of gender.You have a specific type of lung cancer (NSCLC) with certain genetic mutations, and you have already tried medication taken by mouth for it. You may have also tried other treatments before.You have a detectable and measurable tumor that can be monitored by CT or MRI scans using a specific set of criteria called RECIST 1.1.You have enough infection-fighting white blood cells, specifically a count of at least 1,500 per microliter.You have wounds that are not healing, significant bleeding that is ongoing, or difficulty swallowing pills.You have a serious heart condition.You have another type of cancer that is currently active or was diagnosed within the past 2 years that could affect your participation in the study.You have read and agreed to a document that explains the study and you have signed and dated it to show that you understand and consent to participate.If you have Small Cell Lung Cancer, you must have tried platinum-based chemotherapy and up to three other treatments for stage IV cancer. However, you cannot have taken an oral VEGF TKI before. You can have taken an anti-PD-1 or PD-L1 medication before.You have had a major surgery or significant injury within 28 days before starting the study treatment that includes bevacizumab, or any other anti-cancer treatment.You are able to perform daily activities without significant limitations or with only slight limitations.You have advanced lung cancer and have already received chemotherapy, but it didn't work or you declined it. You have not yet received any immunotherapy or certain targeted drugs. You may have received up to three different treatments for your cancer.You have advanced non-small cell lung cancer and have already tried a certain type of immunotherapy called checkpoint inhibitor. You have also tried up to three other treatments for this stage of cancer, but none of them included a specific type of medication.You have thymic carcinoma, but you cannot have surgery at the time of the study. You may have received other treatments before, but not ones that include certain drugs.You haven't fully recovered from the side effects of your previous cancer treatment.You have had an allergic reaction or couldn't tolerate specific cancer treatments before.
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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