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PD-1 Inhibitor
Pembrolizumab + Vorinostat for Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Jhanelle Gray, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
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 up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether combining two drugs, pembrolizumab and vorinostat, can help people with advanced lung cancer.
Who is the study for?
Adults over 18 with Stage IV non-small cell lung cancer (NSCLC) can join this trial. Participants must have measurable disease, adequate organ function, and no prior treatments with certain immune therapies if in Phase II. They should not be on other HDAC inhibitors besides vorinostat or have had recent chemotherapy. Safe sex practices are required to avoid conception during the trial.
What is being tested?
The study tests pembrolizumab alone versus its combination with vorinostat for advanced NSCLC patients. Pembrolizumab is FDA-approved for melanoma and lung cancer; vorinostat is approved for some blood cancers. The goal is to assess the safety and effectiveness of this drug combo.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues, changes in blood counts, potential infection risks, and possibly others specific to each drug's profile.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase I: Maximum Tolerated Dose (MTD)
Secondary study objectives
Phase II: Progression Free Survival (PFS) per Treatment Arm
Other study objectives
Upper arm
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Phase Ib ExpansionExperimental Treatment2 Interventions
Pembrolizumab plus Vorinostat.
Level 1: Maximum Tolerated Dose (MTD)
Group II: Phase I Dose EscalationExperimental Treatment2 Interventions
Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks
Group III: Arm B: Pembrolizumab plus VorinostatActive Control2 Interventions
Pembrolizumab plus Vorinostat treatment.
Level 1: MTD
Group IV: Arm A: PembrolizumabActive Control1 Intervention
Pembrolizumab treatment only.
Level 1: Pembrolizumab 200 mg Q3 wks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorinostat
2014
Completed Phase 3
~1600
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,724 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,119 Total Patients Enrolled
Jhanelle Gray, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
6 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of tuberculosis.I have previously received treatments targeting the immune system for cancer.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I received chest radiation of more than 30Gy less than 6 months ago.I haven't had any cancer antibody treatments in the last 4 weeks or have recovered from their side effects.I have never been treated with drugs targeting the immune system for cancer.I haven't had chemotherapy in the last 3 weeks or targeted therapy/radiation in the last 2 weeks, and I've recovered from previous treatment side effects.Your tumor has a PD-L1 score of at least 1%.I am fully active or restricted in physically strenuous activity but can do light work.My diagnosis is Stage IV non-small cell lung cancer.You have a measurable tumor according to specific guidelines for evaluating tumors.I have been diagnosed with interstitial lung disease.My condition worsened after at least one treatment.I haven't received treatment for stage IV cancer, except targeted therapy for specific mutations.My organs are functioning well.I agree to use barrier contraception during and for 120 days after the study.I have been treated for an autoimmune disease in the last 2 years.I have or had lung inflammation treated with steroids.I have a history of heart failure that affects my daily activities.I am not taking any HDAC inhibitors except for vorinostat.I have not received a live vaccine in the last 30 days.I am 18 years old or older.You have a current, active infection of Hepatitis B or Hepatitis C.I am currently being treated for an infection.I am willing to provide a new tissue sample from my tumor for the study.I am not allergic to pembrolizumab, vorinostat, or their ingredients.I have another cancer that is getting worse or needs treatment.I have been diagnosed with HIV.I have fully recovered from any major surgery before starting treatment.I have cancer that has spread to my brain or spinal cord.I can provide tissue samples from previous biopsies if available.I am using two birth control methods or am not having sex to avoid pregnancy during and after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Dose Escalation
- Group 2: Arm B: Pembrolizumab plus Vorinostat
- Group 3: Phase Ib Expansion
- Group 4: Arm A: Pembrolizumab
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.
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