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Checkpoint Inhibitor
Osimertinib + Ipilimumab for Lung Cancer (Osi+Ipi Trial)
Phase 1
Waitlist Available
Led By Wallace Akerley, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed metastatic, non-small cell lung cancer (NSCLC)
Presence of any sensitizing epidermal growth factor receptor (EGFR) tumor mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will remain on treatment until progression and then followed for survival for 5 years from the end of treatment visit.
Awards & highlights
Osi+Ipi Trial Summary
This trial is testing a new medical treatment and is open to new participants. It starts with a phase 1b safety run-in to test how safe the treatment is, followed by an expansion cohort to test how effective the treatment is.
Who is the study for?
This trial is for adults with metastatic non-small cell lung cancer (NSCLC) that has a specific EGFR mutation. Participants must have an ECOG Performance Status of ≤2, indicating they are ambulatory and capable of self-care. They should not have had prior EGFR targeted therapy or recent radiation, and cannot have uncontrolled brain metastases or autoimmune diseases. Effective contraception is required if there's a risk of conception.Check my eligibility
What is being tested?
The study tests the combination of Osimertinib, a medication targeting certain mutations in NSCLC, with Ipilimumab, an immunotherapy drug. It starts with assessing safety (phase 1b), followed by evaluating how well this combination works in more patients (expansion cohort).See study design
What are the potential side effects?
Possible side effects include diarrhea, skin rash, liver enzyme elevation suggesting inflammation or damage to the liver cells; fatigue; immune-related conditions such as colitis or pneumonitis; hormonal gland problems leading to changes in mood or behavior.
Osi+Ipi Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be non-small cell and has spread.
Select...
My tumor has a specific EGFR mutation.
Select...
I have been taking a stable dose of osimertinib for at least 28 days without my cancer getting worse.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Osi+Ipi Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will remain on treatment until progression and then followed for survival for 5 years from the end of treatment visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will remain on treatment until progression and then followed for survival for 5 years from the end of treatment visit.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Short and Long term tolerability of ipilimumab in combination with osimertinib: Adverse Events (AEs)
Secondary outcome measures
Ipilimumab
Efficacy of osimertinib in combination with ipilimumab: Ipilimumab progression free survival (iPFS)
Efficacy of osimertinib in combination with ipilimumab: Objective response rate (ORR)
+2 moreSide effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
Osi+Ipi Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment: all patientsExperimental Treatment2 Interventions
Patients entering trial should be on stable dose of osi for ≥4 weeks. Patients will self-administer osi by mouth regardless of food once daily. Doses should be taken at about the same time every day (±6hrs) and recorded on the patient dosing diary. Doses missed outside of the dosing window should not be made up but patients should be instructed to take their next dose at their regularly scheduled time. Ipi will be administered at the assigned dose level every 21 days (±3days) for a max of 4 doses. Ipi must be infused using a volumetric pump over 90min (±10min) through an IV line. Upon completion of the ipilimumab regimen, patients will continue osimertinib daily until disease progression, initiation of new anti-cancer therapy, or death by any cause.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,095 Previous Clinical Trials
1,775,561 Total Patients Enrolled
Wallace Akerley, MDPrincipal InvestigatorHuntsman Cancer Institute
4 Previous Clinical Trials
204 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am post-menopausal or not pregnant.My lung cancer is confirmed to be non-small cell and has spread.I am not on immunosuppressive medication, except for allowed steroids.My tumor has a specific EGFR mutation.You have had a serious allergic reaction to the study drug or any of its ingredients in the past.My blood, liver, and kidney functions are all within normal ranges.I do not have any serious recent illnesses or heart conditions that are not under control.I have been taking a stable dose of osimertinib for at least 28 days without my cancer getting worse.I am using or willing to use effective birth control during and after the study.I have recovered from previous treatment side effects, or they are mild and stable.I have previously received treatment targeting EGFR.I have an autoimmune disease that could worsen with immune-boosting treatments.I have a history of immune-related colitis, bowel disease, or lung inflammation.You have a long-term infection of hepatitis B or C virus with a detectable amount of the virus in your blood.I have conditions like abscesses or blockages in my abdomen that increase my risk for bowel tears.I have HIV with a detectable viral load in the last 6 months.I have not received a live vaccine in the last 4 weeks.I haven't had any cancer except for certain skin cancers or early-stage cancers in the last 2 years.My brain metastases are not under control.I have not had radiation therapy in the last 2 weeks.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: all patients
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.
Has Ipilimumab received clearance from the FDA?
"Ipilimumab's safety was given a 1 on our scale due to the lack of data supporting its efficacy, as this is only Phase 1 clinical trial."
Answered by AI
What applications is Ipilimumab most commonly employed for?
"For those with advanced colorectal carcinoma, who have experienced progression after treatment with fluoropyrimidine, oxaliplatin and irinotecan, and whose regional lymph nodes are larger than 1mm in diameter, ipilimumab may be a viable course of action."
Answered by AI
Is the enrollment period still open for this research project?
"Indeed, the trial is still searching for participants and has been since August 20th 2020. The data on clinicaltrials.gov was also recently updated in April 2021 of this year."
Answered by AI
What is the enrolment capacity of this trial?
"That is correct. According to clinicaltrials.gov, the research was first made available on August 20th 2020 and has been actively recruiting since then, with a most recent update taking place April 21st 2022. The medical trial requires 26 participants from 1 site for data collection purposes."
Answered by AI
Are there any prior experiments involving Ipilimumab?
"At present, 55 Phase 3 studies of Ipilimumab are in progress with 418 active clinical trials. Although Uniondale, New york is the main hub for research into this drug, there are over 25 thousand locations conducting experiments on it worldwide."
Answered by AI
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